Trial Outcomes & Findings for Rintatolimod and IFN Alpha-2b for the Treatment of COVID-19 in Cancer Patients (NCT NCT04379518)
NCT ID: NCT04379518
Last Updated: 2026-01-13
Results Overview
This refers to the frequency of grade 3 or 4 AEs considered to be probably or definitely related to the treatment regimen. Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE version \[v\] 5.0).
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
4 participants
Primary outcome timeframe
Up to 30 days post treatment initiation, On average, the timeframe is 25 days
Results posted on
2026-01-13
Participant Flow
Participant milestones
| Measure |
1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2
Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2
Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
3. Experimental: Rrintatolimod Plus Standard of Care)
Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care.
Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2
Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2
Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2
Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2
Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
3. Experimental: Rrintatolimod Plus Standard of Care)
Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care.
Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2
Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2
Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Rintatolimod and IFN Alpha-2b for the Treatment of COVID-19 in Cancer Patients
Baseline characteristics by cohort
| Measure |
1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2
n=4 Participants
Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2
Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
3. Experimental: Rrintatolimod Plus Standard of Care)
Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care.
Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2
Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2
Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=210 Participants
|
—
|
—
|
—
|
—
|
0 Participants
n=20 Participants
|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 6.0 • n=210 Participants
|
—
|
—
|
—
|
—
|
66.3 years
STANDARD_DEVIATION 6.0 • n=20 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=210 Participants
|
—
|
—
|
—
|
—
|
2 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=210 Participants
|
—
|
—
|
—
|
—
|
2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=210 Participants
|
—
|
—
|
—
|
—
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=210 Participants
|
—
|
—
|
—
|
—
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=210 Participants
|
—
|
—
|
—
|
—
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=210 Participants
|
—
|
—
|
—
|
—
|
4 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=210 Participants
|
—
|
—
|
—
|
—
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=210 Participants
|
—
|
—
|
—
|
—
|
0 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days post treatment initiation, On average, the timeframe is 25 daysPopulation: All treated and eligible patients
This refers to the frequency of grade 3 or 4 AEs considered to be probably or definitely related to the treatment regimen. Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE version \[v\] 5.0).
Outcome measures
| Measure |
1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2
n=4 Participants
Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2
Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
3. Experimental: Rrintatolimod Plus Standard of Care)
Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care.
Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2
Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2
Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Treatment and days 1, 3/4, 7 and 11Population: All treated and eligible patients
Will be assessed as cycle threshold values in nasopharyngeal swabs based on quantitative polymerase chain reaction (PCR) in the course of treatment and days 1, 3/4, 7, and 11.
Outcome measures
| Measure |
1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2
n=4 Participants
Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2
Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
3. Experimental: Rrintatolimod Plus Standard of Care)
Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care.
Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2
Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2
Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
|---|---|---|---|---|---|
|
Kinetics of Viral Load
C1D1
|
4300100.7 Viral Copy Number / mL
Standard Deviation 5.9
|
—
|
—
|
—
|
—
|
|
Kinetics of Viral Load
C1D3/4
|
190808.2 Viral Copy Number / mL
|
—
|
—
|
—
|
—
|
|
Kinetics of Viral Load
C1D7
|
1974796.7 Viral Copy Number / mL
|
—
|
—
|
—
|
—
|
|
Kinetics of Viral Load
C1D11
|
16.6 Viral Copy Number / mL
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 30 days post treatment initiationPopulation: All treated and evaluable participants
Will be assessed by the frequency of these complications: (i) progression of infection requiring hospitalization; (ii) respiratory failure requiring mechanical ventilation (primary efficacy endpoint); and (iii) death within 30 days. If present, acute respiratory distress syndrome will be graded by Berlin criteria.
Outcome measures
| Measure |
1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2
n=4 Participants
Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2
Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
3. Experimental: Rrintatolimod Plus Standard of Care)
Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care.
Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2
Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2
Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
|---|---|---|---|---|---|
|
Number of Participants With Selected Clinical Efficacy Complications
Total Number of Participants with complications
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Selected Clinical Efficacy Complications
Number of participants that experienced progression of infection requiring hospitalization
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Selected Clinical Efficacy Complications
Number of participants experienced failure requiring mechanical ventilation
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Selected Clinical Efficacy Complications
Number of participants that died within 30 days
|
2 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 3, 7, 14 post treatment initiationPopulation: All treated and eligible patients
Will be assessed as cycle threshold values in the peripheral blood and nasopharyngeal swab based on quantitative PCR in the course of treatment and days 1, 3, 7, and 14. Data entered are values that were measured, no "placeholders" were entered, zero is a valid measurement.
Outcome measures
| Measure |
1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2
n=3 Participants
Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2
Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
3. Experimental: Rrintatolimod Plus Standard of Care)
Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care.
Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2
Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2
Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
|---|---|---|---|---|---|
|
Kinetics of Viral Load
C1D1
|
0.0 Relative mRNA abundance
Standard Deviation 0.0
|
—
|
—
|
—
|
—
|
|
Kinetics of Viral Load
C1D3
|
0.0 Relative mRNA abundance
|
—
|
—
|
—
|
—
|
|
Kinetics of Viral Load
C1D7
|
0.31 Relative mRNA abundance
Standard Deviation 0.43
|
—
|
—
|
—
|
—
|
|
Kinetics of Viral Load
C1D14
|
0.0 Relative mRNA abundance
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4 , 7, 14 and 30 post treatment initiationPopulation: All treated and eligible patients
Gene expresssion measured by qPCR
Outcome measures
| Measure |
1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2
n=4 Participants
Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2
Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
3. Experimental: Rrintatolimod Plus Standard of Care)
Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care.
Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2
Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2
Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
|---|---|---|---|---|---|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (COX2)
D14
|
1.67 Relative mRNA abundance
Standard Deviation 1.99
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (COX2)
D30
|
4.71 Relative mRNA abundance
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (COX2)
D1 Pre
|
0.82 Relative mRNA abundance
Standard Deviation 0.65
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (COX2)
D1 Post
|
0.68 Relative mRNA abundance
Standard Deviation 0.77
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (COX2)
D4 Pre
|
1.14 Relative mRNA abundance
Standard Deviation 0.99
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (COX2)
D4 Post
|
1.0 Relative mRNA abundance
Standard Deviation 0.35
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (COX2)
D7
|
4.68 Relative mRNA abundance
Standard Deviation 6.92
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 7, 14 and 30 post treatmentPopulation: All treated and eligible patients
Gene expression measured by QPCR
Outcome measures
| Measure |
1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2
n=4 Participants
Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2
Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
3. Experimental: Rrintatolimod Plus Standard of Care)
Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care.
Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2
Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2
Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
|---|---|---|---|---|---|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CCL5)
D1 Pre
|
23.0 Relative mRNA abundance
Standard Deviation 37.5
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CCL5)
D1 Post
|
18.6 Relative mRNA abundance
Standard Deviation 30.5
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CCL5)
D4 Pre
|
32.0 Relative mRNA abundance
Standard Deviation 39.6
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CCL5)
D4 Post
|
28.9 Relative mRNA abundance
Standard Deviation 17.0
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CCL5)
D7
|
19.6 Relative mRNA abundance
Standard Deviation 28.0
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CCL5)
D14
|
57.9 Relative mRNA abundance
Standard Deviation 60.0
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CCL5)
D30
|
116.7 Relative mRNA abundance
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 7, 14, and 30 post treatmentPopulation: All treated and eligible patients
Gene expression measured by qPCR
Outcome measures
| Measure |
1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2
n=4 Participants
Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2
Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
3. Experimental: Rrintatolimod Plus Standard of Care)
Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care.
Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2
Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2
Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
|---|---|---|---|---|---|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CXCL10)
D1 Pre
|
0.01 Relative mRNA abundance
Standard Deviation 0.01
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CXCL10)
D1 Post
|
0.01 Relative mRNA abundance
Standard Deviation 0.01
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CXCL10)
D4 Pre
|
0.03 Relative mRNA abundance
Standard Deviation 0.01
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CXCL10)
D4 Post
|
0.04 Relative mRNA abundance
Standard Deviation 0.01
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CXCL10)
D7
|
0.04 Relative mRNA abundance
Standard Deviation 0.04
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CXCL10)
D14
|
0.03 Relative mRNA abundance
Standard Deviation 0.002
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CXCL10)
D30
|
0.05 Relative mRNA abundance
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 7, 14 and 30 post treatmentPopulation: All treated and eligible patients
Gene expression measured by qPCR
Outcome measures
| Measure |
1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2
n=4 Participants
Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2
Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
3. Experimental: Rrintatolimod Plus Standard of Care)
Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care.
Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2
Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2
Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
|---|---|---|---|---|---|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CCL22)
D1 Post
|
0.0001 Relative mRNA abundance
Standard Deviation 0.0001
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CCL22)
D4 Pre
|
0.0023 Relative mRNA abundance
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CCL22)
D4 Post
|
0.0018 Relative mRNA abundance
Standard Deviation 0.0013
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CCL22)
D7
|
0.0011 Relative mRNA abundance
Standard Deviation 0.0009
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CCL22)
D14
|
0.0043 Relative mRNA abundance
Standard Deviation 0.0050
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CCL22)
D30
|
0.0033 Relative mRNA abundance
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CCL22)
D1 Pre
|
0.0013 Relative mRNA abundance
Standard Deviation 0.0007
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 7, and 30 post treatmentPopulation: All treated and eligible patients, participants with data collected at each time point were analyzed.
Gene expression measured by qPCR
Outcome measures
| Measure |
1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2
n=4 Participants
Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2
Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
3. Experimental: Rrintatolimod Plus Standard of Care)
Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care.
Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2
Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2
Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
|---|---|---|---|---|---|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CXCL12)
D1 Pre
|
0.0038 Relative mRNA abundance
Standard Deviation 0.0006
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CXCL12)
D1 Post
|
2,003.9 Relative mRNA abundance
Standard Deviation 3,470.8
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CXCL12)
D4 Pre
|
0.00021 Relative mRNA abundance
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CXCL12)
D4 Post
|
0.0011 Relative mRNA abundance
Standard Deviation 0.0012
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CXCL12)
D7
|
0.0005 Relative mRNA abundance
Standard Deviation 0.0003
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CXCL12)
D30
|
0.0039 Relative mRNA abundance
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 7, 14 and 30 post treatmentPopulation: All treated and eligible patients
gene expression measured by qPCR
Outcome measures
| Measure |
1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2
n=4 Participants
Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2
Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
3. Experimental: Rrintatolimod Plus Standard of Care)
Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care.
Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2
Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2
Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
|---|---|---|---|---|---|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IL-10)
D1 Pre
|
0.075 Relative mRNA abundance
Standard Deviation 0.069
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IL-10)
D1 Post
|
0.055 Relative mRNA abundance
Standard Deviation 0.064
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IL-10)
D4 Pre
|
0.059 Relative mRNA abundance
Standard Deviation 0.054
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IL-10)
D4 Post
|
0.047 Relative mRNA abundance
Standard Deviation 0.033
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IL-10)
D7
|
0.072 Relative mRNA abundance
Standard Deviation 0.071
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IL-10)
D14
|
0.021 Relative mRNA abundance
Standard Deviation 0.007
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IL-10)
D30
|
0.014 Relative mRNA abundance
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 7, 14 and 30 post treatmentPopulation: All treated and eligible patients
Gene expression measured by qPCR
Outcome measures
| Measure |
1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2
n=4 Participants
Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2
Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
3. Experimental: Rrintatolimod Plus Standard of Care)
Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care.
Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2
Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2
Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
|---|---|---|---|---|---|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IDO1)
D1 Pre
|
0.005 Relative mRNA abundance
Standard Deviation 0.008
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IDO1)
D1 Post
|
0.007 Relative mRNA abundance
Standard Deviation 0.009
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IDO1)
D7
|
0.019 Relative mRNA abundance
Standard Deviation 0.010
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IDO1)
D14
|
0.019 Relative mRNA abundance
Standard Deviation 0.010
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IDO1)
D30
|
0.029 Relative mRNA abundance
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IDO1)
D4 Pre
|
0.018 Relative mRNA abundance
Standard Deviation 0.00001
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IDO1)
D4 Post
|
0.015 Relative mRNA abundance
Standard Deviation 0.003
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 7, 14 and 30 post treatmentPopulation: All treated and eligible patients
Gene expression measured by qPCR
Outcome measures
| Measure |
1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2
n=4 Participants
Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2
Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
3. Experimental: Rrintatolimod Plus Standard of Care)
Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care.
Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2
Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2
Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
|---|---|---|---|---|---|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IFNB1)
D1 Pre
|
0.19 Relative mRNA abundance
Standard Deviation 0.18
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IFNB1)
D1 Post
|
0.35 Relative mRNA abundance
Standard Deviation 0.48
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IFNB1)
D4 Pre
|
0.83 Relative mRNA abundance
Standard Deviation 0.96
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IFNB1)
D4 Post
|
0.85 Relative mRNA abundance
Standard Deviation 1.03
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IFNB1)
D7
|
0.50 Relative mRNA abundance
Standard Deviation 0.50
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IFNB1)
D14
|
1.30 Relative mRNA abundance
Standard Deviation 1.56
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IFNB1)
D30
|
1.68 Relative mRNA abundance
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 7, 14 and 30 post treatmentPopulation: All treated and eligible patients
Gene expression measured by qPCR
Outcome measures
| Measure |
1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2
n=4 Participants
Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2
Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
3. Experimental: Rrintatolimod Plus Standard of Care)
Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care.
Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2
Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2
Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
|---|---|---|---|---|---|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IFNa)
D1 Pre
|
0.13 Relative mRNA abundance
Standard Deviation 0.12
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IFNa)
D1 Post
|
0.22 Relative mRNA abundance
Standard Deviation 0.27
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IFNa)
D4 Pre
|
0.60 Relative mRNA abundance
Standard Deviation 0.65
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IFNa)
D4 Post
|
0.68 Relative mRNA abundance
Standard Deviation 0.83
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IFNa)
D7
|
0.42 Relative mRNA abundance
Standard Deviation 0.42
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IFNa)
D14
|
0.82 Relative mRNA abundance
Standard Deviation 0.94
|
—
|
—
|
—
|
—
|
|
Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IFNa)
D30
|
1.58 Relative mRNA abundance
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 7, 14 and 30 post treatmentPopulation: All treated and eligible patients
Induction of known mediator RIG-1 of antiviral immunity measured by qPCR
Outcome measures
| Measure |
1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2
n=4 Participants
Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2
Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
3. Experimental: Rrintatolimod Plus Standard of Care)
Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care.
Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2
Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2
Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
|---|---|---|---|---|---|
|
Known Mediators of Antiviral Immunity (RIG-1)
D1 Pre
|
0.27 Relative mRNA abundance
Standard Deviation 0.22
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (RIG-1)
D1 Post
|
0.47 Relative mRNA abundance
Standard Deviation 0.42
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (RIG-1)
D4 Pre
|
0.50 Relative mRNA abundance
Standard Deviation 0.17
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (RIG-1)
D4 Post
|
0.63 Relative mRNA abundance
Standard Deviation 0.30
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (RIG-1)
D7
|
0.45 Relative mRNA abundance
Standard Deviation 0.36
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (RIG-1)
D14
|
0.53 Relative mRNA abundance
Standard Deviation 0.33
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (RIG-1)
D30
|
1.16 Relative mRNA abundance
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 7, 14 and 30 post treatmentPopulation: All treated and eligible patients
Induction of known mediator TLR-3 of antiviral immunity measured by qPCR
Outcome measures
| Measure |
1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2
n=4 Participants
Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2
Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
3. Experimental: Rrintatolimod Plus Standard of Care)
Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care.
Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2
Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2
Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
|---|---|---|---|---|---|
|
Known Mediators of Antiviral Immunity (TLR-3)
D30
|
0.06 Relative mRNA abundance
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (TLR-3)
D1 Pre
|
0.01 Relative mRNA abundance
Standard Deviation 0.01
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (TLR-3)
D1 Post
|
0.02 Relative mRNA abundance
Standard Deviation 0.02
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (TLR-3)
D4 Pre
|
0.02 Relative mRNA abundance
Standard Deviation 0.03
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (TLR-3)
D4 Post
|
0.03 Relative mRNA abundance
Standard Deviation 0.03
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (TLR-3)
D7
|
0.01 Relative mRNA abundance
Standard Deviation 0.01
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (TLR-3)
D14
|
0.04 Relative mRNA abundance
Standard Deviation 0.04
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 7, 14 and 30 post treatmentPopulation: All treated and eligible patients
Induction of known mediator ISG-15 of antiviral immunity measured by qPCR
Outcome measures
| Measure |
1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2
n=4 Participants
Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2
Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
3. Experimental: Rrintatolimod Plus Standard of Care)
Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care.
Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2
Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2
Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
|---|---|---|---|---|---|
|
Known Mediators of Antiviral Immunity (ISG-15)
D1 Pre
|
1.29 Relative mRNA abundance
Standard Deviation 2.26
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (ISG-15)
D1 Post
|
1.49 Relative mRNA abundance
Standard Deviation 2.62
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (ISG-15)
D4 Pre
|
0.02 Relative mRNA abundance
Standard Deviation 0.02
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (ISG-15)
D4 Post
|
0.24 Relative mRNA abundance
Standard Deviation 0.02
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (ISG-15)
D7
|
0.37 Relative mRNA abundance
Standard Deviation 0.14
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (ISG-15)
D14
|
0.02 Relative mRNA abundance
Standard Deviation 0.002
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (ISG-15)
D30
|
0.23 Relative mRNA abundance
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 7, 14 and 30 post treatmentPopulation: All treated and eligible patients
Induction of known mediator RNAseL of antiviral immunity measured by qPCR
Outcome measures
| Measure |
1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2
n=4 Participants
Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2
Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
3. Experimental: Rrintatolimod Plus Standard of Care)
Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care.
Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2
Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2
Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
|---|---|---|---|---|---|
|
Known Mediators of Antiviral Immunity (RNAseL)
D1 Pre
|
0.06 Relative mRNA abundance
Standard Deviation 0.04
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (RNAseL)
D1 Post
|
0.10 Relative mRNA abundance
Standard Deviation 0.06
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (RNAseL)
D4 Pre
|
0.10 Relative mRNA abundance
Standard Deviation 0.07
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (RNAseL)
D4 Post
|
0.15 Relative mRNA abundance
Standard Deviation 0.07
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (RNAseL)
D7
|
0.13 Relative mRNA abundance
Standard Deviation 0.08
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (RNAseL)
D14
|
0.10 Relative mRNA abundance
Standard Deviation 0.08
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (RNAseL)
D30
|
0.28 Relative mRNA abundance
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 7, 14 and 30 post treatmentPopulation: All treated and eligible patients
Induction of known mediator OAS2 of antiviral immunity measured by qPCR
Outcome measures
| Measure |
1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2
n=4 Participants
Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2
Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
3. Experimental: Rrintatolimod Plus Standard of Care)
Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care.
Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2
Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2
Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
|---|---|---|---|---|---|
|
Known Mediators of Antiviral Immunity (OAS2)
D1 Pre
|
1.62 Relative mRNA abundance
Standard Deviation 1.44
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (OAS2)
D1 Post
|
1.92 Relative mRNA abundance
Standard Deviation 1.79
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (OAS2)
D4 Pre
|
1.54 Relative mRNA abundance
Standard Deviation 0.82
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (OAS2)
D4 Post
|
2.94 Relative mRNA abundance
Standard Deviation 1.02
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (OAS2)
D7
|
1.98 Relative mRNA abundance
Standard Deviation 1.30
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (OAS2)
D14
|
2.30 Relative mRNA abundance
Standard Deviation 0.66
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (OAS2)
D30
|
2.74 Relative mRNA abundance
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, and 14 post treatmentPopulation: All treated and eligible patients
Induction of known mediator ACE2 of antiviral immunity measured by qPCR
Outcome measures
| Measure |
1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2
n=2 Participants
Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2
Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
3. Experimental: Rrintatolimod Plus Standard of Care)
Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care.
Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2
Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2
Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
|---|---|---|---|---|---|
|
Known Mediators of Antiviral Immunity (ACE2)
D1 Post
|
0.00012 Relative mRNA abundance
Standard Deviation 0.00013
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (ACE2)
D14
|
0.0004 Relative mRNA abundance
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 7, 14 and 30 post treatmentPopulation: All treated and eligible patients
Induction of known mediator Mx1 of antiviral immunity measured by qPCR
Outcome measures
| Measure |
1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2
n=4 Participants
Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2
Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
3. Experimental: Rrintatolimod Plus Standard of Care)
Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care.
Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2
Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2
Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
|---|---|---|---|---|---|
|
Known Mediators of Antiviral Immunity (Mx1)
D1 Pre
|
2.42 Relative mRNA abundance
Standard Deviation 1.69
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (Mx1)
D1 Post
|
3.15 Relative mRNA abundance
Standard Deviation 2.81
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (Mx1)
D4 Pre
|
2.60 Relative mRNA abundance
Standard Deviation 1.65
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (Mx1)
D4 Post
|
3.88 Relative mRNA abundance
Standard Deviation 1.57
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (Mx1)
D7
|
3.13 Relative mRNA abundance
Standard Deviation 1.12
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (Mx1)
D14
|
2.42 Relative mRNA abundance
Standard Deviation 1.12
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (Mx1)
D30
|
3.40 Relative mRNA abundance
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 7, 14 and 30 post treatmentPopulation: All treated and eligible patients
Induction of known mediator IFIT1 of antiviral immunity measured by qPCR
Outcome measures
| Measure |
1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2
n=4 Participants
Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2
Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
3. Experimental: Rrintatolimod Plus Standard of Care)
Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care.
Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2
Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2
Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
|---|---|---|---|---|---|
|
Known Mediators of Antiviral Immunity (IFIT1)
D7
|
1.34 Relative mRNA abundance
Standard Deviation 1.00
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (IFIT1)
D14
|
2.22 Relative mRNA abundance
Standard Deviation 2.37
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (IFIT1)
D30
|
3.83 Relative mRNA abundance
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (IFIT1)
D1 Pre
|
0.99 Relative mRNA abundance
Standard Deviation 0.56
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (IFIT1)
D1 Post
|
1.29 Relative mRNA abundance
Standard Deviation 1.20
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (IFIT1)
D4 Pre
|
1.44 Relative mRNA abundance
Standard Deviation 1.34
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (IFIT1)
D4 Post
|
2.14 Relative mRNA abundance
Standard Deviation 2.15
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 7, 14 and 30 post treatmentPopulation: All treated and eligible patients
Induction of known mediator IFITM3 of antiviral immunity measured by qPCR
Outcome measures
| Measure |
1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2
n=4 Participants
Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2
Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
3. Experimental: Rrintatolimod Plus Standard of Care)
Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care.
Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2
Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2
Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
|---|---|---|---|---|---|
|
Known Mediators of Antiviral Immunity (IFITM3)
D1 Pre
|
17.45 Relative mRNA abundance
Standard Deviation 21.64
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (IFITM3)
D1 Post
|
13.97 Relative mRNA abundance
Standard Deviation 13.93
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (IFITM3)
D4 Pre
|
11.10 Relative mRNA abundance
Standard Deviation 1.77
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (IFITM3)
D4 Post
|
14.55 Relative mRNA abundance
Standard Deviation 1.07
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (IFITM3)
D7
|
12.48 Relative mRNA abundance
Standard Deviation 4.78
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (IFITM3)
D14
|
7.11 Relative mRNA abundance
Standard Deviation 0.96
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (IFITM3)
D30
|
5.93 Relative mRNA abundance
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 7, 14 and 30 post treatmentPopulation: All treated and eligible patients
Induction of known mediator IRF3 of antiviral immunity measured by qPCR
Outcome measures
| Measure |
1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2
n=4 Participants
Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2
Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
3. Experimental: Rrintatolimod Plus Standard of Care)
Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care.
Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2
Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2
Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
|---|---|---|---|---|---|
|
Known Mediators of Antiviral Immunity (IRF3)
D1 Pre
|
2.89 Relative mRNA abundance
Standard Deviation 2.83
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (IRF3)
D1 Post
|
3.04 Relative mRNA abundance
Standard Deviation 2.49
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (IRF3)
D4 Pre
|
3.07 Relative mRNA abundance
Standard Deviation 3.33
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (IRF3)
D4 Post
|
4.14 Relative mRNA abundance
Standard Deviation 4.13
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (IRF3)
D7
|
2.23 Relative mRNA abundance
Standard Deviation 2.08
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (IRF3)
D14
|
4.26 Relative mRNA abundance
Standard Deviation 4.31
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (IRF3)
D30
|
8.14 Relative mRNA abundance
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 7, 14 and 30 post treatmentPopulation: All treated and eligible patients
Induction of known mediator IRF7 of antiviral immunity measured by qPCR
Outcome measures
| Measure |
1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2
n=4 Participants
Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2
Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
3. Experimental: Rrintatolimod Plus Standard of Care)
Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care.
Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2
Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2
Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
|---|---|---|---|---|---|
|
Known Mediators of Antiviral Immunity (IRF7)
D1 Pre
|
0.79 Relative mRNA abundance
Standard Deviation 8.88
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (IRF7)
D1 Post
|
0.41 Relative mRNA abundance
Standard Deviation 0.51
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (IRF7)
D4 Pre
|
0.47 Relative mRNA abundance
Standard Deviation 0.45
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (IRF7)
D4 Post
|
0.79 Relative mRNA abundance
Standard Deviation 0.58
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (IRF7)
D7
|
0.54 Relative mRNA abundance
Standard Deviation 0.47
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (IRF7)
D14
|
0.49 Relative mRNA abundance
Standard Deviation 0.40
|
—
|
—
|
—
|
—
|
|
Known Mediators of Antiviral Immunity (IRF7)
D30
|
0.91 Relative mRNA abundance
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 30 days post treatment initiationPopulation: No patients were evaluable.
Will assess the induction of known mediators of antiviral immunity that include (myxovirus resistance gene, MxA; protein Kinase R; oligoadenylate synthetase-2; RNAse-L, IFN-stimulated gene-15 (ISG15); IFN-induced proteins with tetratricopeptide repeats, and IFN-inducible transmembrane protein 3, TLR3, RIG-I, MDA5, IRF3, IRF7, in nasopharyngeal swabs material and blood cells of patients on all tiers of treatment. Will also assess the expression of ACE2 (receptor for severe acute respiratory syndrome coronavirus 2 \[SARS-Cov-2\] entry) and potentially other genes involved in SARS-CoV-2 infection will be tested in nasopharyngeal samples.
Outcome measures
Outcome data not reported
Adverse Events
1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3. Experimental: Rrintatolimod Plus Standard of Care)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2
n=4 participants at risk
Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2
"Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD"
|
3. Experimental: Rrintatolimod Plus Standard of Care)
"Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care.
Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD"
|
4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2
"Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD"
|
5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2
"Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD"
|
|---|---|---|---|---|---|
|
Infections and infestations
Infections and infestations - Other, specify
|
50.0%
2/4 • Number of events 2 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
Other adverse events
| Measure |
1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2
n=4 participants at risk
Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
|
2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2
"Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD"
|
3. Experimental: Rrintatolimod Plus Standard of Care)
"Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care.
Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD"
|
4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2
"Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD"
|
5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2
"Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M\^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD"
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
1/4 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
25.0%
1/4 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
25.0%
1/4 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
|
General disorders
Edema limbs
|
25.0%
1/4 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 2 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
|
General disorders
Flu like symptoms
|
25.0%
1/4 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
|
Infections and infestations
Sinusitis
|
25.0%
1/4 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
|
Investigations
Neutrophil count decreased
|
25.0%
1/4 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
|
Investigations
Platelet count decreased
|
25.0%
1/4 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
|
Psychiatric disorders
Depression
|
25.0%
1/4 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
|
Vascular disorders
Hypotension
|
25.0%
1/4 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
|
Vascular disorders
Thromboembolic event
|
25.0%
1/4 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
—
0/0 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place