Trial Outcomes & Findings for Comparative Efficacy of Fixed-dose Combination Sofosbuvir + Ledipasvir, 8 vs. 12 Weeks in Chronic Hepatitis C Genotype 6 (NCT NCT02480166)
NCT ID: NCT02480166
Last Updated: 2017-09-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
12 weeks after end of therapy
Results posted on
2017-09-19
Participant Flow
Participant milestones
| Measure |
8 Weeks SOF/LED
Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.
8 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.
|
12 Weeks SOF/LED
Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.
12 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.
|
Extended Treatment to 12 Weeks SOF/LED
Subjects without cirrhosis or prior treatment history received extended treatment to 12 weeks by investigator's preference
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
36
|
4
|
|
Overall Study
COMPLETED
|
20
|
36
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Efficacy of Fixed-dose Combination Sofosbuvir + Ledipasvir, 8 vs. 12 Weeks in Chronic Hepatitis C Genotype 6
Baseline characteristics by cohort
| Measure |
8 Weeks SOF/LED
n=20 Participants
Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.
8 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.
|
12 Weeks SOF/LED
n=36 Participants
Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.
12 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.
|
Extended Treatment to 12 Weeks SOF/LED
n=4 Participants
Subjects without cirrhosis or prior treatment history received extended treatment to 12 weeks by investigator's preference
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 8 • n=5 Participants
|
60 years
STANDARD_DEVIATION 12 • n=7 Participants
|
54 years
STANDARD_DEVIATION 10 • n=5 Participants
|
59 years
STANDARD_DEVIATION 10 • n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Vietnamese
|
16 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Cambodian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
BMI
|
22.4 kg/m^2
STANDARD_DEVIATION 4.2 • n=5 Participants
|
24.2 kg/m^2
STANDARD_DEVIATION 2.7 • n=7 Participants
|
24.1 kg/m^2
STANDARD_DEVIATION 3.6 • n=5 Participants
|
23.6 kg/m^2
STANDARD_DEVIATION 3.3 • n=4 Participants
|
|
Comorbidities
Diabetes
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Comorbidities
Hypertension
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Comorbidities
Hyperlipidemia
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Comorbidities
Coronary Artery Disease (CAD)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Comorbidities
Chronic Obstructive Pulmonary Disease (COPD)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
HCV Genotype SubType
a/b
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
HCV Genotype SubType
c-l
|
8 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
HCV Genotype SubType
c
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
HCV Genotype SubType
m
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Baseline Cirrhosis
|
0 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Decompensated Cirrhosis
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Hepatocellular Carcinoma
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Prior Treatment
|
0 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Proton Pump Inhibitor (PPI) usage
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
MELD, cirrhotics only
|
0 units on a scale
STANDARD_DEVIATION 0 • n=5 Participants
|
6.9 units on a scale
STANDARD_DEVIATION 1.6 • n=7 Participants
|
0 units on a scale
STANDARD_DEVIATION 0 • n=5 Participants
|
6.9 units on a scale
STANDARD_DEVIATION 1.6 • n=4 Participants
|
|
log10 HCV RNA
|
6.2 log10 (IU/ml)
STANDARD_DEVIATION 0.8 • n=5 Participants
|
6.5 log10 (IU/ml)
STANDARD_DEVIATION 0.6 • n=7 Participants
|
7.2 log10 (IU/ml)
STANDARD_DEVIATION 0.3 • n=5 Participants
|
6.5 log10 (IU/ml)
STANDARD_DEVIATION 0.7 • n=4 Participants
|
|
White Blood Cell Count (WBC)
|
5.5 K/uL
STANDARD_DEVIATION 1.4 • n=5 Participants
|
6.0 K/uL
STANDARD_DEVIATION 2.1 • n=7 Participants
|
5.3 K/uL
STANDARD_DEVIATION 0.5 • n=5 Participants
|
5.8 K/uL
STANDARD_DEVIATION 1.8 • n=4 Participants
|
|
Hemoglobin
|
14.3 g/dL
STANDARD_DEVIATION 1.3 • n=5 Participants
|
14.2 g/dL
STANDARD_DEVIATION 1.6 • n=7 Participants
|
14.8 g/dL
STANDARD_DEVIATION 1.1 • n=5 Participants
|
14.2 g/dL
STANDARD_DEVIATION 1.5 • n=4 Participants
|
|
Platelets
|
213 K/uL
n=5 Participants
|
181 K/uL
n=7 Participants
|
201 K/uL
n=5 Participants
|
201 K/uL
n=4 Participants
|
|
Creatinine
|
0.8 mg/dL
STANDARD_DEVIATION 0.1 • n=5 Participants
|
0.9 mg/dL
STANDARD_DEVIATION 0.2 • n=7 Participants
|
0.9 mg/dL
STANDARD_DEVIATION 0.1 • n=5 Participants
|
0.8 mg/dL
STANDARD_DEVIATION 0.2 • n=4 Participants
|
|
International Normalized Ratio (INR)
|
1.0 ratio
STANDARD_DEVIATION 0.2 • n=5 Participants
|
1.0 ratio
STANDARD_DEVIATION 0.1 • n=7 Participants
|
1.0 ratio
STANDARD_DEVIATION 0.0 • n=5 Participants
|
1.0 ratio
STANDARD_DEVIATION 0.1 • n=4 Participants
|
|
Total bilirubin
|
0.7 mg/dL
STANDARD_DEVIATION 0.1 • n=5 Participants
|
0.8 mg/dL
STANDARD_DEVIATION 0.4 • n=7 Participants
|
0.9 mg/dL
STANDARD_DEVIATION 0.1 • n=5 Participants
|
0.7 mg/dL
STANDARD_DEVIATION 0.3 • n=4 Participants
|
|
Aspartate Aminotransferase (AST)
|
36 U/L
n=5 Participants
|
48 U/L
n=7 Participants
|
28 U/L
n=5 Participants
|
39 U/L
n=4 Participants
|
|
Alanine Aminotransferase (ALT)
|
44 U/L
n=5 Participants
|
68 U/L
n=7 Participants
|
33 U/L
n=5 Participants
|
59 U/L
n=4 Participants
|
|
Albumin
|
4.3 g/dL
STANDARD_DEVIATION 0.4 • n=5 Participants
|
4.0 g/dL
STANDARD_DEVIATION 0.7 • n=7 Participants
|
3.5 g/dL
STANDARD_DEVIATION 1.5 • n=5 Participants
|
4.0 g/dL
STANDARD_DEVIATION 0.7 • n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after end of therapyOutcome measures
| Measure |
8 Weeks SOF/LED
n=20 Participants
Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.
8 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.
|
12 Weeks SOF/LED
n=36 Participants
Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.
12 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.
|
Treatment Extension to 12 Weeks SOF/LED
n=4 Participants
Subjects without cirrhosis or prior treatment history received extended treatment to 12 weeks by investigator's preference
|
|---|---|---|---|
|
Number of Participants With a Sustained Virologic Response (SVR) log10 HCV RNA PCR <25 IU/mL 12 Weeks Post-treatment
|
19 Participants
|
34 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 1 of treatment to 12 weeks post treatmentAdverse events were defined using Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
Outcome measures
| Measure |
8 Weeks SOF/LED
n=20 Participants
Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.
8 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.
|
12 Weeks SOF/LED
n=36 Participants
Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.
12 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.
|
Treatment Extension to 12 Weeks SOF/LED
n=4 Participants
Subjects without cirrhosis or prior treatment history received extended treatment to 12 weeks by investigator's preference
|
|---|---|---|---|
|
Number of Participants Who Experienced Serious Adverse Events (SAEs) and/or Adverse Events (AEs) From Informed Consent to 12 Weeks Post-treatment.
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
8 Weeks SOF/LED
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
12 Weeks SOF/LED
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Extended Treatment to 12 Weeks SOF/LED
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
8 Weeks SOF/LED
n=20 participants at risk
Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.
8 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.
|
12 Weeks SOF/LED
n=36 participants at risk
Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.
12 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.
|
Extended Treatment to 12 Weeks SOF/LED
n=4 participants at risk
Subjects without cirrhosis or prior treatment history received extended treatment to 12 weeks by investigator's preference
|
|---|---|---|---|
|
Gastrointestinal disorders
Upper GI Bleed
|
0.00%
0/20 • For each subject, AEs and SAEs are recorded after informed consent is obtained until 12 weeks post treatment.
A Serious Adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 30 days of receiving the last dose of Study Product. Any serious adverse event that is ongoing when a subject completes his/her participation in the Study must be followed until the event resolves or stabilizes, returns baseline condition, or can be attributed to agents(s) other than the Study Product, or unrelated to Study conduct.
|
2.8%
1/36 • Number of events 1 • For each subject, AEs and SAEs are recorded after informed consent is obtained until 12 weeks post treatment.
A Serious Adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 30 days of receiving the last dose of Study Product. Any serious adverse event that is ongoing when a subject completes his/her participation in the Study must be followed until the event resolves or stabilizes, returns baseline condition, or can be attributed to agents(s) other than the Study Product, or unrelated to Study conduct.
|
0.00%
0/4 • For each subject, AEs and SAEs are recorded after informed consent is obtained until 12 weeks post treatment.
A Serious Adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 30 days of receiving the last dose of Study Product. Any serious adverse event that is ongoing when a subject completes his/her participation in the Study must be followed until the event resolves or stabilizes, returns baseline condition, or can be attributed to agents(s) other than the Study Product, or unrelated to Study conduct.
|
|
Surgical and medical procedures
Surgical correction of left wrist fracture
|
0.00%
0/20 • For each subject, AEs and SAEs are recorded after informed consent is obtained until 12 weeks post treatment.
A Serious Adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 30 days of receiving the last dose of Study Product. Any serious adverse event that is ongoing when a subject completes his/her participation in the Study must be followed until the event resolves or stabilizes, returns baseline condition, or can be attributed to agents(s) other than the Study Product, or unrelated to Study conduct.
|
2.8%
1/36 • Number of events 1 • For each subject, AEs and SAEs are recorded after informed consent is obtained until 12 weeks post treatment.
A Serious Adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 30 days of receiving the last dose of Study Product. Any serious adverse event that is ongoing when a subject completes his/her participation in the Study must be followed until the event resolves or stabilizes, returns baseline condition, or can be attributed to agents(s) other than the Study Product, or unrelated to Study conduct.
|
0.00%
0/4 • For each subject, AEs and SAEs are recorded after informed consent is obtained until 12 weeks post treatment.
A Serious Adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 30 days of receiving the last dose of Study Product. Any serious adverse event that is ongoing when a subject completes his/her participation in the Study must be followed until the event resolves or stabilizes, returns baseline condition, or can be attributed to agents(s) other than the Study Product, or unrelated to Study conduct.
|
Other adverse events
| Measure |
8 Weeks SOF/LED
n=20 participants at risk
Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.
8 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.
|
12 Weeks SOF/LED
n=36 participants at risk
Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.
12 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.
|
Extended Treatment to 12 Weeks SOF/LED
n=4 participants at risk
Subjects without cirrhosis or prior treatment history received extended treatment to 12 weeks by investigator's preference
|
|---|---|---|---|
|
General disorders
Fatigue
|
10.0%
2/20 • Number of events 2 • For each subject, AEs and SAEs are recorded after informed consent is obtained until 12 weeks post treatment.
A Serious Adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 30 days of receiving the last dose of Study Product. Any serious adverse event that is ongoing when a subject completes his/her participation in the Study must be followed until the event resolves or stabilizes, returns baseline condition, or can be attributed to agents(s) other than the Study Product, or unrelated to Study conduct.
|
2.8%
1/36 • Number of events 1 • For each subject, AEs and SAEs are recorded after informed consent is obtained until 12 weeks post treatment.
A Serious Adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 30 days of receiving the last dose of Study Product. Any serious adverse event that is ongoing when a subject completes his/her participation in the Study must be followed until the event resolves or stabilizes, returns baseline condition, or can be attributed to agents(s) other than the Study Product, or unrelated to Study conduct.
|
0.00%
0/4 • For each subject, AEs and SAEs are recorded after informed consent is obtained until 12 weeks post treatment.
A Serious Adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 30 days of receiving the last dose of Study Product. Any serious adverse event that is ongoing when a subject completes his/her participation in the Study must be followed until the event resolves or stabilizes, returns baseline condition, or can be attributed to agents(s) other than the Study Product, or unrelated to Study conduct.
|
|
General disorders
Insomnia
|
0.00%
0/20 • For each subject, AEs and SAEs are recorded after informed consent is obtained until 12 weeks post treatment.
A Serious Adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 30 days of receiving the last dose of Study Product. Any serious adverse event that is ongoing when a subject completes his/her participation in the Study must be followed until the event resolves or stabilizes, returns baseline condition, or can be attributed to agents(s) other than the Study Product, or unrelated to Study conduct.
|
5.6%
2/36 • Number of events 2 • For each subject, AEs and SAEs are recorded after informed consent is obtained until 12 weeks post treatment.
A Serious Adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 30 days of receiving the last dose of Study Product. Any serious adverse event that is ongoing when a subject completes his/her participation in the Study must be followed until the event resolves or stabilizes, returns baseline condition, or can be attributed to agents(s) other than the Study Product, or unrelated to Study conduct.
|
0.00%
0/4 • For each subject, AEs and SAEs are recorded after informed consent is obtained until 12 weeks post treatment.
A Serious Adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 30 days of receiving the last dose of Study Product. Any serious adverse event that is ongoing when a subject completes his/her participation in the Study must be followed until the event resolves or stabilizes, returns baseline condition, or can be attributed to agents(s) other than the Study Product, or unrelated to Study conduct.
|
|
General disorders
Nausea
|
0.00%
0/20 • For each subject, AEs and SAEs are recorded after informed consent is obtained until 12 weeks post treatment.
A Serious Adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 30 days of receiving the last dose of Study Product. Any serious adverse event that is ongoing when a subject completes his/her participation in the Study must be followed until the event resolves or stabilizes, returns baseline condition, or can be attributed to agents(s) other than the Study Product, or unrelated to Study conduct.
|
2.8%
1/36 • Number of events 1 • For each subject, AEs and SAEs are recorded after informed consent is obtained until 12 weeks post treatment.
A Serious Adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 30 days of receiving the last dose of Study Product. Any serious adverse event that is ongoing when a subject completes his/her participation in the Study must be followed until the event resolves or stabilizes, returns baseline condition, or can be attributed to agents(s) other than the Study Product, or unrelated to Study conduct.
|
0.00%
0/4 • For each subject, AEs and SAEs are recorded after informed consent is obtained until 12 weeks post treatment.
A Serious Adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 30 days of receiving the last dose of Study Product. Any serious adverse event that is ongoing when a subject completes his/her participation in the Study must be followed until the event resolves or stabilizes, returns baseline condition, or can be attributed to agents(s) other than the Study Product, or unrelated to Study conduct.
|
|
General disorders
Headache
|
0.00%
0/20 • For each subject, AEs and SAEs are recorded after informed consent is obtained until 12 weeks post treatment.
A Serious Adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 30 days of receiving the last dose of Study Product. Any serious adverse event that is ongoing when a subject completes his/her participation in the Study must be followed until the event resolves or stabilizes, returns baseline condition, or can be attributed to agents(s) other than the Study Product, or unrelated to Study conduct.
|
2.8%
1/36 • Number of events 1 • For each subject, AEs and SAEs are recorded after informed consent is obtained until 12 weeks post treatment.
A Serious Adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 30 days of receiving the last dose of Study Product. Any serious adverse event that is ongoing when a subject completes his/her participation in the Study must be followed until the event resolves or stabilizes, returns baseline condition, or can be attributed to agents(s) other than the Study Product, or unrelated to Study conduct.
|
0.00%
0/4 • For each subject, AEs and SAEs are recorded after informed consent is obtained until 12 weeks post treatment.
A Serious Adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 30 days of receiving the last dose of Study Product. Any serious adverse event that is ongoing when a subject completes his/her participation in the Study must be followed until the event resolves or stabilizes, returns baseline condition, or can be attributed to agents(s) other than the Study Product, or unrelated to Study conduct.
|
Additional Information
Mindie H. Nguyen, MD, MAS
Stanford University Medical Center
Phone: 650-4985691
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place