Trial Outcomes & Findings for Donor-Alloantigen-Reactive Regulatory T Cell (darTregs) in Liver Transplantation (NCT NCT02188719)
NCT ID: NCT02188719
Last Updated: 2020-09-22
Results Overview
Biopsy-proven acute rejection graded as Mild, Moderate or Severe, per 1997 Banff classification. Chronic Rejection graded using Banff 2000 classification. References: 1.) Banff Schema for Grading Liver Allograft Rejection: An International Consensus Document developed by an international panel of experts in liver transplantation pathology, hepatology, and surgery (Hepatology 1997; 25(3): 658-663). 2.) Update of the International Banff Schema for Liver Allograft Rejection: Working Recommendations for the Histopathologic Staging and Reporting of Chronic Rejection (Hepatology 2000; 31(3): 792-799).
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
Transplantation to 40 Weeks Post Transplantation
Results posted on
2020-09-22
Participant Flow
Participant milestones
| Measure |
Cohort 1
Participants received Thymoglobulin®+EVR IS but will not receive darTregs
|
Cohort 2
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 50 million(range 25 to 60 million) cells.
|
Cohort 3
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 200 million(range 100 to 240 million) cells. No participants were enrolled in this cohort.
|
Cohort 4
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 800 million(range 400 to 960 million) cells. No participants were enrolled in this cohort.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
9
|
0
|
0
|
|
Overall Study
COMPLETED
|
6
|
8
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1
Participants received Thymoglobulin®+EVR IS but will not receive darTregs
|
Cohort 2
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 50 million(range 25 to 60 million) cells.
|
Cohort 3
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 200 million(range 100 to 240 million) cells. No participants were enrolled in this cohort.
|
Cohort 4
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 800 million(range 400 to 960 million) cells. No participants were enrolled in this cohort.
|
|---|---|---|---|---|
|
Overall Study
Screen B Ineligible (Page 55, Protocol)
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Donor-Alloantigen-Reactive Regulatory T Cell (darTregs) in Liver Transplantation
Baseline characteristics by cohort
| Measure |
Cohort 1
n=6 Participants
Participants received Thymoglobulin®+EVR IS but will not receive darTregs
|
Cohort 2
n=9 Participants
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 50 million(range 25 to 60 million) cells.
|
Cohort 3
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 200 million(range 100 to 240 million) cells. No participants were enrolled in this cohort.
|
Cohort 4
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 800 million(range 400 to 960 million) cells. No participants were enrolled in this cohort.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
62 years
STANDARD_DEVIATION 4.2 • n=7 Participants
|
—
|
—
|
61 years
STANDARD_DEVIATION 4.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
2 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
—
|
—
|
13 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
—
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
—
|
—
|
13 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
—
|
—
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
—
|
—
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
6 Count of Participants
n=5 Participants
|
9 Count of Participants
n=7 Participants
|
—
|
—
|
15 Count of Participants
n=21 Participants
|
|
Alanine Aminotransferase (ALT)
|
47.0 U/L
STANDARD_DEVIATION 66.6 • n=5 Participants
|
216.4 U/L
STANDARD_DEVIATION 543.4 • n=7 Participants
|
—
|
—
|
148.7 U/L
STANDARD_DEVIATION 421.5 • n=21 Participants
|
|
Alkaline Phosphatase
|
64.0 U/L
STANDARD_DEVIATION 17.3 • n=5 Participants
|
102.8 U/L
STANDARD_DEVIATION 44.4 • n=7 Participants
|
—
|
—
|
87.3 U/L
STANDARD_DEVIATION 40.2 • n=21 Participants
|
|
Gamma-Glutamyl Transferase (GGT)
|
40.0 U/L
STANDARD_DEVIATION 11.3 • n=5 Participants
|
115.8 U/L
STANDARD_DEVIATION 97.0 • n=7 Participants
|
—
|
—
|
100.6 U/L
STANDARD_DEVIATION 91.4 • n=21 Participants
|
PRIMARY outcome
Timeframe: Transplantation to 40 Weeks Post TransplantationPopulation: All transplanted participants.
Biopsy-proven acute rejection graded as Mild, Moderate or Severe, per 1997 Banff classification. Chronic Rejection graded using Banff 2000 classification. References: 1.) Banff Schema for Grading Liver Allograft Rejection: An International Consensus Document developed by an international panel of experts in liver transplantation pathology, hepatology, and surgery (Hepatology 1997; 25(3): 658-663). 2.) Update of the International Banff Schema for Liver Allograft Rejection: Working Recommendations for the Histopathologic Staging and Reporting of Chronic Rejection (Hepatology 2000; 31(3): 792-799).
Outcome measures
| Measure |
Cohort 1
n=6 Participants
Participants received Thymoglobulin®+EVR IS but will not receive darTregs
|
Cohort 2
n=9 Participants
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 50 million(range 25 to 60 million) cells.
|
Cohort 3
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 200 million(range 100 to 240 million) cells. No participants were enrolled in this cohort.
|
Cohort 4
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 800 million(range 400 to 960 million) cells. No participants were enrolled in this cohort.
|
|---|---|---|---|---|
|
Percent of Participants With Biopsy-Proven Acute and/or Chronic Rejection
Mild Acute Rejection
|
0 Percent of Participants
|
11.1 Percent of Participants
|
—
|
—
|
|
Percent of Participants With Biopsy-Proven Acute and/or Chronic Rejection
Moderate Acute Rejection
|
0 Percent of Participants
|
0 Percent of Participants
|
—
|
—
|
|
Percent of Participants With Biopsy-Proven Acute and/or Chronic Rejection
Severe Acute Rejection
|
0 Percent of Participants
|
0 Percent of Participants
|
—
|
—
|
|
Percent of Participants With Biopsy-Proven Acute and/or Chronic Rejection
Chronic Rejection
|
0 Percent of Participants
|
0 Percent of Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Transplantation to 40 Weeks Post TransplantationPopulation: All transplanted participants.
The severity of infectious adverse events (AEs) was classified into grades as follows: * Grade 1 = asymptomatic; clinical or diagnostic observation only; intervention with oral antibiotic, antifungal, or antiviral agent only; no invasive intervention required * Grade 2 = symptomatic; intervention with intravenous antibiotic, antifungal, or antiviral agent; invasive intervention may be required * Grade 3 = any infection associated with hemodynamic compromise requiring pressors; any infection necessitating intensive care unit level of care; any infection necessitating operative intervention; any infection involving the central nervous system; any infection with a positive fungal blood culture; any proven or probable aspergillus infection; any tissue invasive fungal infection; any pneumocystis jiroveci infection * Grade 4 = life-threatening infection * Grade 5 = death resulting from infection
Outcome measures
| Measure |
Cohort 1
n=6 Participants
Participants received Thymoglobulin®+EVR IS but will not receive darTregs
|
Cohort 2
n=9 Participants
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 50 million(range 25 to 60 million) cells.
|
Cohort 3
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 200 million(range 100 to 240 million) cells. No participants were enrolled in this cohort.
|
Cohort 4
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 800 million(range 400 to 960 million) cells. No participants were enrolled in this cohort.
|
|---|---|---|---|---|
|
Percent of Participants With Grade 3 or Higher Infectious Adverse Event(s)
|
0 Percent of Participants
|
11.1 Percent of Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Transplantation to 40 Weeks Post TransplantationPopulation: All transplanted participants.
The severity of adverse events (AEs) was classified into grades using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 (4/28/2009): * Grade 3 wound complications are defined as "Hernia without evidence of strangulation; fascial disruption/dehiscence; primary wound closure or revision by operative intervention indicated" * Grade 4 complications are defined as "Hernia with evidence of strangulation; major reconstruction flap, grafting, resection, or amputation indicated"
Outcome measures
| Measure |
Cohort 1
n=6 Participants
Participants received Thymoglobulin®+EVR IS but will not receive darTregs
|
Cohort 2
n=9 Participants
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 50 million(range 25 to 60 million) cells.
|
Cohort 3
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 200 million(range 100 to 240 million) cells. No participants were enrolled in this cohort.
|
Cohort 4
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 800 million(range 400 to 960 million) cells. No participants were enrolled in this cohort.
|
|---|---|---|---|---|
|
Percent of Participants With Grade 3 or Higher Wound Complication(s) Adverse Event(s)
|
0 Percent of Participants
|
0 Percent of Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Transplantation to 40 Weeks Post TransplantationPopulation: All transplanted participants.
The severity of adverse events (AEs) was classified into grades using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 (4/28/2009): * Grade 1 = mild AE * Grade 2 = moderate AE * Grade 3 = severe and undesirable AE * Grade 4 = life-threatening or disabling AE * Grade 5 = death
Outcome measures
| Measure |
Cohort 1
n=6 Participants
Participants received Thymoglobulin®+EVR IS but will not receive darTregs
|
Cohort 2
n=9 Participants
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 50 million(range 25 to 60 million) cells.
|
Cohort 3
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 200 million(range 100 to 240 million) cells. No participants were enrolled in this cohort.
|
Cohort 4
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 800 million(range 400 to 960 million) cells. No participants were enrolled in this cohort.
|
|---|---|---|---|---|
|
Percent of Participants With Grade 2 or Higher Hematologic Adverse Events (AEs) of Anemia, Neutropenia, and/or Thrombocytopenia
Anemia
|
66.7 Percent of Participants
|
22.2 Percent of Participants
|
—
|
—
|
|
Percent of Participants With Grade 2 or Higher Hematologic Adverse Events (AEs) of Anemia, Neutropenia, and/or Thrombocytopenia
Neutropenia
|
16.7 Percent of Participants
|
0 Percent of Participants
|
—
|
—
|
|
Percent of Participants With Grade 2 or Higher Hematologic Adverse Events (AEs) of Anemia, Neutropenia, and/or Thrombocytopenia
Thrombocytopenia
|
16.7 Percent of Participants
|
0 Percent of Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Transplantation to 40 Weeks Post TransplantationPopulation: Limited to participants that received darTreg infusion (N=1 study participant).
AEs classified by the site investigator/clinician as possibly or definitely related to the study treatment, the Donor Alloantigen Reactive Tregs (darTregs) infusion. These AEs include: * infusion reaction * Grade 3 or higher cytokine release syndrome (Reference: National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 (4/28/2009) grading criteria * malignant cellular transformation.
Outcome measures
| Measure |
Cohort 1
Participants received Thymoglobulin®+EVR IS but will not receive darTregs
|
Cohort 2
n=1 Participants
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 50 million(range 25 to 60 million) cells.
|
Cohort 3
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 200 million(range 100 to 240 million) cells. No participants were enrolled in this cohort.
|
Cohort 4
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 800 million(range 400 to 960 million) cells. No participants were enrolled in this cohort.
|
|---|---|---|---|---|
|
Percent of Participants With Adverse Events (AEs) Attributable to the Donor Alloantigen Reactive Tregs (darTregs) Infusion
|
—
|
0 Percent of Participants
|
—
|
—
|
Adverse Events
Cohort 1
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=6 participants at risk
Participants received Thymoglobulin® +EVR IS but will not receive darTregs
|
Cohort 2
n=9 participants at risk
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 50 million(range 25 to 60 million) cells.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Gastrointestinal disorders
Ileus
|
16.7%
1/6 • Number of events 1 • 40 weeks
|
11.1%
1/9 • Number of events 1 • 40 weeks
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/6 • 40 weeks
|
11.1%
1/9 • Number of events 1 • 40 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
General disorders
Chest pain
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
General disorders
Fatigue
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
General disorders
Oedema
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/6 • 40 weeks
|
22.2%
2/9 • Number of events 2 • 40 weeks
|
|
Hepatobiliary disorders
Biliary ischaemia
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Immune system disorders
Liver transplant rejection
|
0.00%
0/6 • 40 weeks
|
11.1%
1/9 • Number of events 1 • 40 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • 40 weeks
|
11.1%
1/9 • Number of events 1 • 40 weeks
|
|
Infections and infestations
Tooth infection
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Infections and infestations
Viral infection
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Infections and infestations
Wound infection
|
16.7%
1/6 • Number of events 1 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
16.7%
1/6 • Number of events 1 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
16.7%
1/6 • Number of events 1 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
16.7%
1/6 • Number of events 1 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Investigations
Weight decreased
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Metabolism and nutrition disorders
Failure to thrive
|
16.7%
1/6 • Number of events 1 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/6 • 40 weeks
|
11.1%
1/9 • Number of events 1 • 40 weeks
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Renal and urinary disorders
Renal failure acute
|
16.7%
1/6 • Number of events 1 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypocapnia
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
Other adverse events
| Measure |
Cohort 1
n=6 participants at risk
Participants received Thymoglobulin® +EVR IS but will not receive darTregs
|
Cohort 2
n=9 participants at risk
Participants received Thymoglobulin®+EVR IS and will receive a darTreg infusion of 50 million(range 25 to 60 million) cells.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
66.7%
4/6 • Number of events 4 • 40 weeks
|
11.1%
1/9 • Number of events 1 • 40 weeks
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/6 • 40 weeks
|
11.1%
1/9 • Number of events 1 • 40 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
1/6 • Number of events 1 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.7%
1/6 • Number of events 1 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • 40 weeks
|
11.1%
1/9 • Number of events 1 • 40 weeks
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/6 • 40 weeks
|
11.1%
1/9 • Number of events 1 • 40 weeks
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
General disorders
Chest pain
|
16.7%
1/6 • Number of events 1 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
General disorders
Fatigue
|
0.00%
0/6 • 40 weeks
|
11.1%
1/9 • Number of events 1 • 40 weeks
|
|
General disorders
Influenza like illness
|
16.7%
1/6 • Number of events 1 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
General disorders
Oedema
|
16.7%
1/6 • Number of events 1 • 40 weeks
|
11.1%
1/9 • Number of events 1 • 40 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Hepatobiliary disorders
Biliary ischaemia
|
0.00%
0/6 • 40 weeks
|
11.1%
1/9 • Number of events 1 • 40 weeks
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/6 • 40 weeks
|
11.1%
1/9 • Number of events 1 • 40 weeks
|
|
Immune system disorders
Liver transplant rejection
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Infections and infestations
Tooth infection
|
16.7%
1/6 • Number of events 1 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • 40 weeks
|
11.1%
1/9 • Number of events 1 • 40 weeks
|
|
Infections and infestations
Viral infection
|
0.00%
0/6 • 40 weeks
|
11.1%
1/9 • Number of events 1 • 40 weeks
|
|
Infections and infestations
Wound infection
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
2/6 • Number of events 2 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Investigations
Blood alkaline phosphatase increased
|
16.7%
1/6 • Number of events 1 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Investigations
Blood creatinine increased
|
16.7%
1/6 • Number of events 1 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
50.0%
3/6 • Number of events 3 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • 40 weeks
|
11.1%
1/9 • Number of events 1 • 40 weeks
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • 40 weeks
|
11.1%
1/9 • Number of events 1 • 40 weeks
|
|
Investigations
Weight decreased
|
0.00%
0/6 • 40 weeks
|
11.1%
1/9 • Number of events 1 • 40 weeks
|
|
Investigations
White blood cell count decreased
|
16.7%
1/6 • Number of events 1 • 40 weeks
|
11.1%
1/9 • Number of events 1 • 40 weeks
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
16.7%
1/6 • Number of events 1 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
16.7%
1/6 • Number of events 1 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • 40 weeks
|
11.1%
1/9 • Number of events 1 • 40 weeks
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Number of events 1 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Renal and urinary disorders
Proteinuria
|
16.7%
1/6 • Number of events 1 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/6 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypocapnia
|
16.7%
1/6 • Number of events 1 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
1/6 • Number of events 1 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
16.7%
1/6 • Number of events 1 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Number of events 1 • 40 weeks
|
0.00%
0/9 • 40 weeks
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/6 • 40 weeks
|
11.1%
1/9 • Number of events 1 • 40 weeks
|
Additional Information
Director, Clinical Research Operations Program
DAIT/NIAID
Phone: 301-594-7669
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place