Trial Outcomes & Findings for A Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection (NCT NCT04398134)
NCT ID: NCT04398134
Last Updated: 2022-09-15
Results Overview
Describes the number of participants with One or More Adverse Events while they were on treatment with the study drug.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
88 participants
Primary outcome timeframe
Up to 72 weeks
Results posted on
2022-09-15
Participant Flow
Participant milestones
| Measure |
ABI-H2158 Plus ETV (HBeAg Positive Population)
ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
ABI-H2158: 3 X 100 mg tablets for oral administration
Entecavir (ETV): 0.5 mg tablet for oral administration
|
Placebo Plus ETV (HBeAg Positive Population)
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets
Entecavir (ETV): 0.5 mg tablet for oral administration
|
ABI-H2158 Plus ETV (HBeAg Negative Population)
ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
ABI-H2158: 3 X 100 mg tablets for oral administration
Entecavir (ETV): 0.5 mg tablet for oral administration
|
Placebo Plus ETV (HBeAg Negative Population)
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets
Entecavir (ETV): 0.5 mg tablet for oral administration
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
32
|
11
|
33
|
12
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
32
|
11
|
33
|
12
|
Reasons for withdrawal
| Measure |
ABI-H2158 Plus ETV (HBeAg Positive Population)
ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
ABI-H2158: 3 X 100 mg tablets for oral administration
Entecavir (ETV): 0.5 mg tablet for oral administration
|
Placebo Plus ETV (HBeAg Positive Population)
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets
Entecavir (ETV): 0.5 mg tablet for oral administration
|
ABI-H2158 Plus ETV (HBeAg Negative Population)
ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
ABI-H2158: 3 X 100 mg tablets for oral administration
Entecavir (ETV): 0.5 mg tablet for oral administration
|
Placebo Plus ETV (HBeAg Negative Population)
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets
Entecavir (ETV): 0.5 mg tablet for oral administration
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
1
|
|
Overall Study
Study Terminated by Sponsor
|
30
|
11
|
32
|
11
|
Baseline Characteristics
A Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection
Baseline characteristics by cohort
| Measure |
ABI-H2158 Plus ETV (HBeAg Positive Population)
n=32 Participants
ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
ABI-H2158: 3 X 100 mg tablets for oral administration
Entecavir (ETV): 0.5 mg tablet for oral administration
|
Placebo Plus ETV (HBeAg Positive Population)
n=11 Participants
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets
Entecavir (ETV): 0.5 mg tablet for oral administration
|
ABI-H2158 Plus ETV (HBeAg Negative Population)
n=33 Participants
ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
ABI-H2158: 3 X 100 mg tablets for oral administration
Entecavir (ETV): 0.5 mg tablet for oral administration
|
Placebo Plus ETV (HBeAg Negative Population)
n=12 Participants
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets
Entecavir (ETV): 0.5 mg tablet for oral administration
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
35 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
44 years
STANDARD_DEVIATION 11 • n=5 Participants
|
46 years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
41 years
STANDARD_DEVIATION 10.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
48 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=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
32 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
85 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=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Region of Enrollment
New Zealand
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
1 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Region of Enrollment
South Korea
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
0 participants
n=4 Participants
|
7 participants
n=21 Participants
|
|
Region of Enrollment
Hong Kong
|
8 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
3 participants
n=4 Participants
|
19 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
3 participants
n=4 Participants
|
21 participants
n=21 Participants
|
|
Region of Enrollment
China
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
10 participants
n=5 Participants
|
4 participants
n=4 Participants
|
22 participants
n=21 Participants
|
|
Region of Enrollment
Taiwan
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
1 participants
n=4 Participants
|
9 participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 72 weeksDescribes the number of participants with One or More Adverse Events while they were on treatment with the study drug.
Outcome measures
| Measure |
ABI-H2158 Plus ETV (HBeAg Positive Population)
n=32 Participants
ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
ABI-H2158: 3 X 100 mg tablets for oral administration
Entecavir (ETV): 0.5 mg tablet for oral administration
|
Placebo Plus ETV (HBeAg Positive Population)
n=11 Participants
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets
Entecavir (ETV): 0.5 mg tablet for oral administration
|
ABI-H2158 Plus ETV (HBeAg Negative Population)
n=33 Participants
ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
ABI-H2158: 3 X 100 mg tablets for oral administration
Entecavir (ETV): 0.5 mg tablet for oral administration
|
Placebo Plus ETV (HBeAg Negative Population)
n=12 Participants
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets
Entecavir (ETV): 0.5 mg tablet for oral administration
|
|---|---|---|---|---|
|
Percentage of Participants With Adverse Events
|
18 Participants
|
6 Participants
|
19 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to 72 weeksDescribes the number of participants who discontinued treatment with ABI-H2158/placebo prematurely.
Outcome measures
| Measure |
ABI-H2158 Plus ETV (HBeAg Positive Population)
n=32 Participants
ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
ABI-H2158: 3 X 100 mg tablets for oral administration
Entecavir (ETV): 0.5 mg tablet for oral administration
|
Placebo Plus ETV (HBeAg Positive Population)
n=11 Participants
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets
Entecavir (ETV): 0.5 mg tablet for oral administration
|
ABI-H2158 Plus ETV (HBeAg Negative Population)
n=33 Participants
ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
ABI-H2158: 3 X 100 mg tablets for oral administration
Entecavir (ETV): 0.5 mg tablet for oral administration
|
Placebo Plus ETV (HBeAg Negative Population)
n=12 Participants
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets
Entecavir (ETV): 0.5 mg tablet for oral administration
|
|---|---|---|---|---|
|
Percentage of Participants With Premature Treatment Discontinuation
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: Due to early termination of the study, samples at Week 24 from participants in the HBeAg negative cohort were not collected.
HBV DNA was measured by Cobas AmpliPrep/ Cobas TaqMan HBV Test v2.0 (LOD 10 IU/mL). The analysis of data was descriptive only.
Outcome measures
| Measure |
ABI-H2158 Plus ETV (HBeAg Positive Population)
n=5 Participants
ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
ABI-H2158: 3 X 100 mg tablets for oral administration
Entecavir (ETV): 0.5 mg tablet for oral administration
|
Placebo Plus ETV (HBeAg Positive Population)
n=2 Participants
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets
Entecavir (ETV): 0.5 mg tablet for oral administration
|
ABI-H2158 Plus ETV (HBeAg Negative Population)
ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
ABI-H2158: 3 X 100 mg tablets for oral administration
Entecavir (ETV): 0.5 mg tablet for oral administration
|
Placebo Plus ETV (HBeAg Negative Population)
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets
Entecavir (ETV): 0.5 mg tablet for oral administration
|
|---|---|---|---|---|
|
Change From Baseline in Mean log10 HBV DNA
|
-6.2 log10 IU/mL
Standard Deviation 0.76
|
-4.8 log10 IU/mL
Standard Deviation 0.25
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 72 weeksSeverity grades were defined by Grading Scale for Severity of Adverse Events and Laboratory Abnormalities \[The DAIDS Version 2.1\]. For maximum postbaseline toxicity grade, the most severe graded abnormality from all tests was counted for each participant. For each individual laboratory test, the most severe graded abnormality for that test was counted for a participant. A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the date of last dose of ABI-H2158/Placebo plus 28 days.
Outcome measures
| Measure |
ABI-H2158 Plus ETV (HBeAg Positive Population)
n=32 Participants
ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
ABI-H2158: 3 X 100 mg tablets for oral administration
Entecavir (ETV): 0.5 mg tablet for oral administration
|
Placebo Plus ETV (HBeAg Positive Population)
n=11 Participants
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets
Entecavir (ETV): 0.5 mg tablet for oral administration
|
ABI-H2158 Plus ETV (HBeAg Negative Population)
n=33 Participants
ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
ABI-H2158: 3 X 100 mg tablets for oral administration
Entecavir (ETV): 0.5 mg tablet for oral administration
|
Placebo Plus ETV (HBeAg Negative Population)
n=12 Participants
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets
Entecavir (ETV): 0.5 mg tablet for oral administration
|
|---|---|---|---|---|
|
Percentage of Participants With Abnormal Laboratory Results
|
29 Participants
|
8 Participants
|
19 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Predose on Day 1, Week 4, Week 48, and Week 72Population: Due to early termination of the study, data were not collected and analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose on Day 1 and Weeks 4, 48, and 72 and at pre-specified intervals after dosing on Day 1 and Weeks 2, 8, 12, 16, 20, 24, and 28Population: Due to early termination of the study, data were not collected and analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose on Day 1, Week 4, Week 48, and Week 72Population: Due to early termination of the study, data were not collected and analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose on Day 1 and Weeks 4, 48, and 72 and at pre-specified intervals after dosing on Day 1 and Weeks 2, 8, 12, 16, 20, 24, and 28Population: Due to early termination of the study, data were not collected and analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to Week 72Population: Due to early termination of the study, data were not collected and analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 72 weeksPopulation: Due to early termination of the study, data were not collected and analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 72 weeksPopulation: Due to early termination of the study, data were not collected and analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to 72 weeksPopulation: Due to early termination of the study, data were not collected and analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to 72 weeksPopulation: Due to early termination of the study, data were not collected and analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to 72 weeksPopulation: Due to early termination of the study, data were not collected and analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to Week 24Population: Due to early termination of the study, data were not collected and analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 72 weeksPopulation: Due to early termination of the study, data were not collected and analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 72 weeksPopulation: Due to early termination of the study, data were not collected and analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
Adverse Events
ABI-H2158 Plus ETV (HBeAg Positive Population)
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo Plus ETV (HBeAg Positive Population)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
ABI-H2158 Plus ETV (HBeAg Negative Population)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo Plus ETV (HBeAg Negative Population)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ABI-H2158 Plus ETV (HBeAg Positive Population)
n=32 participants at risk
ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
ABI-H2158: 3 X 100 mg tablets for oral administration
Entecavir (ETV): 0.5 mg tablet for oral administration
|
Placebo Plus ETV (HBeAg Positive Population)
n=11 participants at risk
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets
Entecavir (ETV): 0.5 mg tablet for oral administration
|
ABI-H2158 Plus ETV (HBeAg Negative Population)
n=33 participants at risk
ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
ABI-H2158: 3 X 100 mg tablets for oral administration
Entecavir (ETV): 0.5 mg tablet for oral administration
|
Placebo Plus ETV (HBeAg Negative Population)
n=12 participants at risk
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets
Entecavir (ETV): 0.5 mg tablet for oral administration
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
8.3%
1/12 • Number of events 1 • Up to 72 weeks
|
|
Nervous system disorders
Altered state of consciousness
|
3.1%
1/32 • Number of events 1 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/32 • Up to 72 weeks
|
9.1%
1/11 • Number of events 1 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
Other adverse events
| Measure |
ABI-H2158 Plus ETV (HBeAg Positive Population)
n=32 participants at risk
ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
ABI-H2158: 3 X 100 mg tablets for oral administration
Entecavir (ETV): 0.5 mg tablet for oral administration
|
Placebo Plus ETV (HBeAg Positive Population)
n=11 participants at risk
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets
Entecavir (ETV): 0.5 mg tablet for oral administration
|
ABI-H2158 Plus ETV (HBeAg Negative Population)
n=33 participants at risk
ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
ABI-H2158: 3 X 100 mg tablets for oral administration
Entecavir (ETV): 0.5 mg tablet for oral administration
|
Placebo Plus ETV (HBeAg Negative Population)
n=12 participants at risk
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets
Entecavir (ETV): 0.5 mg tablet for oral administration
|
|---|---|---|---|---|
|
Investigations
alanine aminotransferase increased
|
15.6%
5/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
6.1%
2/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
6.2%
2/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
6.1%
2/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Nervous system disorders
headache
|
3.1%
1/32 • Up to 72 weeks
|
9.1%
1/11 • Up to 72 weeks
|
9.1%
3/33 • Up to 72 weeks
|
8.3%
1/12 • Up to 72 weeks
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
9.1%
3/33 • Up to 72 weeks
|
8.3%
1/12 • Up to 72 weeks
|
|
Gastrointestinal disorders
abdominal pain upper
|
0.00%
0/32 • Up to 72 weeks
|
9.1%
1/11 • Up to 72 weeks
|
6.1%
2/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Investigations
white blood cell count decreased
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
6.1%
2/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Metabolism and nutrition disorders
hyperuricaemia
|
3.1%
1/32 • Up to 72 weeks
|
18.2%
2/11 • Up to 72 weeks
|
6.1%
2/33 • Up to 72 weeks
|
16.7%
2/12 • Up to 72 weeks
|
|
Metabolism and nutrition disorders
hyperlipidaemia
|
0.00%
0/32 • Up to 72 weeks
|
9.1%
1/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
8.3%
1/12 • Up to 72 weeks
|
|
Injury, poisoning and procedural complications
vaccination complication
|
6.2%
2/32 • Up to 72 weeks
|
9.1%
1/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Skin and subcutaneous tissue disorders
rash
|
6.2%
2/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Skin and subcutaneous tissue disorders
rash erythematous
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
6.1%
2/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Infections and infestations
urinary tract infection
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
8.3%
1/12 • Up to 72 weeks
|
|
Infections and infestations
folliculitis
|
0.00%
0/32 • Up to 72 weeks
|
9.1%
1/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Psychiatric disorders
anxiety
|
0.00%
0/32 • Up to 72 weeks
|
9.1%
1/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/32 • Up to 72 weeks
|
9.1%
1/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Metabolism and nutrition disorders
decreased appetite
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Psychiatric disorders
depression
|
0.00%
0/32 • Up to 72 weeks
|
9.1%
1/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
8.3%
1/12 • Up to 72 weeks
|
|
Metabolism and nutrition disorders
gout
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Renal and urinary disorders
Haematuria
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Investigations
Haemoglobin Decreased
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/32 • Up to 72 weeks
|
9.1%
1/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Metabolism and nutrition disorders
Hyperlactacidaemia
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
8.3%
1/12 • Up to 72 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Investigations
International Normalised Ratio Increased
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Psychiatric disorders
Irritability
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Gastrointestinal disorders
Large Intestine Polyp
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Psychiatric disorders
Libido Increased
|
0.00%
0/32 • Up to 72 weeks
|
9.1%
1/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Investigations
Lymphocyte Count Decreased
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
8.3%
1/12 • Up to 72 weeks
|
|
General disorders
Malaise
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Reproductive system and breast disorders
Menstruation Delayed
|
0.00%
0/32 • Up to 72 weeks
|
9.1%
1/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Gastrointestinal disorders
Mesenteric Panniculitis
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Investigations
Monocyte Count Increased
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Twitching
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Eye disorders
Ocular Hyperaemia
|
0.00%
0/32 • Up to 72 weeks
|
9.1%
1/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Cardiac disorders
Palpitations
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Nervous system disorders
Poor Quality Sleep
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Injury, poisoning and procedural complications
Post Vaccination Syndrome
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Investigations
Prothrombin Time Prolonged
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
8.3%
1/12 • Up to 72 weeks
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Alkalosis
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Cardiac disorders
Sinus Bradycardia
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Nervous system disorders
Somnolence
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Cardiac disorders
Supraventricular Extrasystoles
|
0.00%
0/32 • Up to 72 weeks
|
9.1%
1/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
8.3%
1/12 • Up to 72 weeks
|
|
Injury, poisoning and procedural complications
Tooth Fracture
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Investigations
Transaminases Increased
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Infections and infestations
Viral Infection
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Investigations
Weight Decreased
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Gastrointestinal disorders
Nausea
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
8.3%
1/12 • Up to 72 weeks
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
General disorders
Pyrexia
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
8.3%
1/12 • Up to 72 weeks
|
|
General disorders
Chest Pain
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
General disorders
Fatigue
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
General disorders
Asthenia
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Investigations
Amylase Increased
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
8.3%
1/12 • Up to 72 weeks
|
|
Investigations
Blood Bilirubin Increased
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Nervous system disorders
Dizziness
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Nervous system disorders
Altered State Of Consciousness
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
0.00%
0/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
|
Renal and urinary disorders
Proteinuria
|
3.1%
1/32 • Up to 72 weeks
|
0.00%
0/11 • Up to 72 weeks
|
3.0%
1/33 • Up to 72 weeks
|
0.00%
0/12 • Up to 72 weeks
|
Additional Information
Executive Director of Clinical Operations
Assembly Biosciences
Phone: 833-509-4583
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Assembly Biosciences agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Assembly Biosciences supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER