Trial Outcomes & Findings for A Platform Study to Evaluate Investigational Therapies in Chronic Hepatitis B Infection (NCT NCT05612581)
NCT ID: NCT05612581
Last Updated: 2026-02-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
33 participants
Primary outcome timeframe
Up to 48 weeks
Results posted on
2026-02-09
Participant Flow
Participants were not enrolled in Cohort 1a, 2a,3a, 5a and 1b Arms/Groups
Participant milestones
| Measure |
STRIVE: Cohort 1a (VIR-3434 + TDF)
Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total
VIR-3434: VIR-3434 given by subcutaneous injection
TDF: TDF given orally
|
STRIVE: Cohort 2a (VIR-3434 + TDF)
Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total
VIR-3434: VIR-3434 given by subcutaneous injection
TDF: TDF given orally
|
STRIVE: Cohort 3a (VIR-3434 + TDF)
Participants will receive combination therapy with VIR-3434 + TDF for 36 or 40 weeks total
VIR-3434: VIR-3434 given by subcutaneous injection
TDF: TDF given orally
|
STRIVE: Cohort 4a (VIR-3434 + VIR-2218 + TDF)
Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 20 or 44 weeks total
VIR-3434: VIR-3434 given by subcutaneous injection
VIR-2218: VIR-2218 given by subcutaneous injection
TDF: TDF given orally
|
STRIVE: Cohort 5a (VIR-3434 + VIR-2218 + TDF + PEG-IFNα)
Participants will receive combination therapy with VIR-3434 + VIR-2218 +TDF + PEG-IFNα for 48 weeks total
VIR-3434: VIR-3434 given by subcutaneous injection
VIR-2218: VIR-2218 given by subcutaneous injection
TDF: TDF given orally
PEG-IFNα: PEG-IFNα given by subcutaneous injection
|
THRIVE: Cohort 1b (VIR-3434 + TDF)
Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks
VIR-3434: VIR-3434 given by subcutaneous injection
TDF: TDF given orally
|
THRIVE: Cohort 2b (VIR-3434 + VIR-2218 + TDF)
Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 44 weeks total
VIR-3434: VIR-3434 given by subcutaneous injection
VIR-2218: VIR-2218 given by subcutaneous injection
TDF: TDF given orally
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
0
|
16
|
0
|
0
|
17
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
11
|
0
|
0
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
5
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Platform Study to Evaluate Investigational Therapies in Chronic Hepatitis B Infection
Baseline characteristics by cohort
| Measure |
STRIVE: Cohort 1a (VIR-3434 + TDF)
Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total
VIR-3434: VIR-3434 given by subcutaneous injection
TDF: TDF given orally
|
STRIVE: Cohort 2a (VIR-3434 + TDF)
Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total
VIR-3434: VIR-3434 given by subcutaneous injection
TDF: TDF given orally
|
STRIVE: Cohort 3a (VIR-3434 + TDF)
Participants will receive combination therapy with VIR-3434 + TDF for 36 or 40 weeks total
VIR-3434: VIR-3434 given by subcutaneous injection
TDF: TDF given orally
|
STRIVE: Cohort 4a (VIR-3434 + VIR-2218 + TDF)
n=16 Participants
Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 20 or 44 weeks total
VIR-3434: VIR-3434 given by subcutaneous injection
VIR-2218: VIR-2218 given by subcutaneous injection
TDF: TDF given orally
|
STRIVE: Cohort 5a (VIR-3434 + VIR-2218 + TDF + PEG-IFNα)
Participants will receive combination therapy with VIR-3434 + VIR-2218 +TDF + PEG-IFNα for 48 weeks total
VIR-3434: VIR-3434 given by subcutaneous injection
VIR-2218: VIR-2218 given by subcutaneous injection
TDF: TDF given orally
PEG-IFNα: PEG-IFNα given by subcutaneous injection
|
THRIVE: Cohort 1b (VIR-3434 + TDF)
Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks
VIR-3434: VIR-3434 given by subcutaneous injection
TDF: TDF given orally
|
THRIVE: Cohort 2b (VIR-3434 + VIR-2218 + TDF)
n=17 Participants
Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 44 weeks total
VIR-3434: VIR-3434 given by subcutaneous injection
VIR-2218: VIR-2218 given by subcutaneous injection
TDF: TDF given orally
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=362 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=96 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=362 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
16 Participants
n=17 Participants
|
0 Participants
n=96 Participants
|
0 Participants
n=2 Participants
|
17 Participants
n=6 Participants
|
33 Participants
n=2 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=362 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=96 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
|
Age, Continuous
STRIVE: Cohort 4a
|
—
|
—
|
—
|
43.3 years
STANDARD_DEVIATION 9.67 • n=17 Participants
|
—
|
—
|
0 years
STANDARD_DEVIATION 0 • n=6 Participants
|
43.3 years
STANDARD_DEVIATION 9.67 • n=2 Participants
|
|
Age, Continuous
THRIVE: Cohort 2b
|
—
|
—
|
—
|
0 years
STANDARD_DEVIATION 0 • n=17 Participants
|
—
|
—
|
48.4 years
STANDARD_DEVIATION 9.78 • n=6 Participants
|
48.4 years
STANDARD_DEVIATION 9.78 • n=2 Participants
|
|
Sex: Female, Male
Female
|
—
|
—
|
—
|
10 Participants
n=17 Participants
|
—
|
—
|
9 Participants
n=6 Participants
|
19 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
—
|
—
|
—
|
6 Participants
n=17 Participants
|
—
|
—
|
8 Participants
n=6 Participants
|
14 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
—
|
—
|
0 Participants
n=17 Participants
|
—
|
—
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
—
|
—
|
16 Participants
n=17 Participants
|
—
|
—
|
17 Participants
n=6 Participants
|
33 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
—
|
0 Participants
n=17 Participants
|
—
|
—
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
—
|
—
|
0 Participants
n=17 Participants
|
—
|
—
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
—
|
—
|
6 Participants
n=17 Participants
|
—
|
—
|
7 Participants
n=6 Participants
|
13 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
—
|
—
|
0 Participants
n=17 Participants
|
—
|
—
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
—
|
—
|
2 Participants
n=17 Participants
|
—
|
—
|
5 Participants
n=6 Participants
|
7 Participants
n=2 Participants
|
|
Race (NIH/OMB)
White
|
—
|
—
|
—
|
7 Participants
n=17 Participants
|
—
|
—
|
5 Participants
n=6 Participants
|
12 Participants
n=2 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
—
|
—
|
0 Participants
n=17 Participants
|
—
|
—
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
—
|
1 Participants
n=17 Participants
|
—
|
—
|
0 Participants
n=6 Participants
|
1 Participants
n=2 Participants
|
|
Region of Enrollment
New Zealand
|
—
|
—
|
—
|
0 Participants
n=17 Participants
|
—
|
—
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
|
Region of Enrollment
South Korea
|
—
|
—
|
—
|
1 Participants
n=17 Participants
|
—
|
—
|
5 Participants
n=6 Participants
|
6 Participants
n=2 Participants
|
|
Region of Enrollment
Romania
|
—
|
—
|
—
|
6 Participants
n=17 Participants
|
—
|
—
|
2 Participants
n=6 Participants
|
8 Participants
n=2 Participants
|
|
Region of Enrollment
Hong Kong
|
—
|
—
|
—
|
4 Participants
n=17 Participants
|
—
|
—
|
2 Participants
n=6 Participants
|
6 Participants
n=2 Participants
|
|
Region of Enrollment
United Kingdom
|
—
|
—
|
—
|
3 Participants
n=17 Participants
|
—
|
—
|
3 Participants
n=6 Participants
|
6 Participants
n=2 Participants
|
|
Region of Enrollment
Moldova
|
—
|
—
|
—
|
0 Participants
n=17 Participants
|
—
|
—
|
2 Participants
n=6 Participants
|
2 Participants
n=2 Participants
|
|
Region of Enrollment
France
|
—
|
—
|
—
|
2 Participants
n=17 Participants
|
—
|
—
|
3 Participants
n=6 Participants
|
5 Participants
n=2 Participants
|
|
Region of Enrollment
Thailand
|
—
|
—
|
—
|
0 Participants
n=17 Participants
|
—
|
—
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
|
Hepatitis B surface antigen (Log10 IU/mL)
STRIVE: Cohort 4a
|
—
|
—
|
—
|
3.64 Log10 IU/mL
STANDARD_DEVIATION 0.72 • n=17 Participants
|
—
|
—
|
0 Log10 IU/mL
STANDARD_DEVIATION 0 • n=6 Participants
|
3.64 Log10 IU/mL
STANDARD_DEVIATION 0.72 • n=2 Participants
|
|
Hepatitis B surface antigen (Log10 IU/mL)
THRIVE: Cohort 2b
|
—
|
—
|
—
|
0 Log10 IU/mL
STANDARD_DEVIATION 0 • n=17 Participants
|
—
|
—
|
3.12 Log10 IU/mL
STANDARD_DEVIATION 0.66 • n=6 Participants
|
3.12 Log10 IU/mL
STANDARD_DEVIATION 0.66 • n=2 Participants
|
|
Hepatitis B e antigen status
HBeAg positive
|
—
|
—
|
—
|
3 Participants
n=17 Participants
|
—
|
—
|
0 Participants
n=6 Participants
|
3 Participants
n=2 Participants
|
|
Hepatitis B e antigen status
HBeAg negative
|
—
|
—
|
—
|
13 Participants
n=17 Participants
|
—
|
—
|
17 Participants
n=6 Participants
|
30 Participants
n=2 Participants
|
|
Alanine Aminotransferase (U/L)
STRIVE: Cohort 4a
|
—
|
—
|
—
|
50.4 U/L
STANDARD_DEVIATION 33.26 • n=17 Participants
|
—
|
—
|
0 U/L
STANDARD_DEVIATION 0 • n=6 Participants
|
50.4 U/L
STANDARD_DEVIATION 33.26 • n=2 Participants
|
|
Alanine Aminotransferase (U/L)
THRIVE: Cohort 2b
|
—
|
—
|
—
|
0 U/L
STANDARD_DEVIATION 0 • n=17 Participants
|
—
|
—
|
25.3 U/L
STANDARD_DEVIATION 20.61 • n=6 Participants
|
25.3 U/L
STANDARD_DEVIATION 20.61 • n=2 Participants
|
|
Hepatitis B Virus DNA (Log10 IU/mL)
STRIVE: Cohort 4a
|
—
|
—
|
—
|
5.21 Log10 IU/mL
STANDARD_DEVIATION 1.71 • n=17 Participants
|
—
|
—
|
0 Log10 IU/mL
STANDARD_DEVIATION 0 • n=6 Participants
|
5.21 Log10 IU/mL
STANDARD_DEVIATION 1.71 • n=2 Participants
|
|
Hepatitis B Virus DNA (Log10 IU/mL)
THRIVE: Cohort 2b
|
—
|
—
|
—
|
0 Log10 IU/mL
STANDARD_DEVIATION 0 • n=17 Participants
|
—
|
—
|
2.61 Log10 IU/mL
STANDARD_DEVIATION 0.70 • n=6 Participants
|
2.61 Log10 IU/mL
STANDARD_DEVIATION 0.70 • n=2 Participants
|
PRIMARY outcome
Timeframe: Up to 48 weeksPopulation: Cohort 1a, 2a, 3a,5a and 1b was not opened for enrollment
Outcome measures
| Measure |
STRIVE: Cohort 1a (VIR-3434 + TDF)
Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total
VIR-3434: VIR-3434 given by subcutaneous injection
TDF: TDF given orally
|
STRIVE: Cohort 2a (VIR-3434 + TDF)
Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total
VIR-3434: VIR-3434 given by subcutaneous injection
TDF: TDF given orally
|
STRIVE: Cohort 3a (VIR-3434 + TDF)
Participants will receive combination therapy with VIR-3434 + TDF for 36 or 40 weeks total
VIR-3434: VIR-3434 given by subcutaneous injection
TDF: TDF given orally
|
STRIVE: Cohort 4a (VIR-3434 + VIR-2218 + TDF)
n=16 Participants
Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 20 or 44 weeks total
VIR-3434: VIR-3434 given by subcutaneous injection
VIR-2218: VIR-2218 given by subcutaneous injection
TDF: TDF given orally
|
STRIVE: Cohort 5a (VIR-3434 + VIR-2218 + TDF + PEG-IFNα)
Participants will receive combination therapy with VIR-3434 + VIR-2218 +TDF + PEG-IFNα for 48 weeks total
VIR-3434: VIR-3434 given by subcutaneous injection
VIR-2218: VIR-2218 given by subcutaneous injection
TDF: TDF given orally
PEG-IFNα: PEG-IFNα given by subcutaneous injection
|
THRIVE: Cohort 1b (VIR-3434 + TDF)
Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks
VIR-3434: VIR-3434 given by subcutaneous injection
TDF: TDF given orally
|
THRIVE: Cohort 2b (VIR-3434 + VIR-2218 + TDF)
n=17 Participants
Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 44 weeks total
VIR-3434: VIR-3434 given by subcutaneous injection
VIR-2218: VIR-2218 given by subcutaneous injection
TDF: TDF given orally
|
|---|---|---|---|---|---|---|---|
|
STRIVE and THRIVE: Proportion of Participants Achieving Suppression of HBV DNA (< LLOQ) With HBsAg Loss (< 0.05 IU/mL) at the End of Treatment
|
—
|
—
|
—
|
1 Participants
|
—
|
—
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 96 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 48 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 72 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 96 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 96 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 96 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 96 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 76 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 96 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 72 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 96 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 72 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 96 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 96 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 96 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 96 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 92 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 44 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 68 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 92 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 92 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 92 weeksOutcome measures
Outcome data not reported
Adverse Events
STRIVE: Cohort 1a (VIR-3434 + TDF)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
STRIVE: Cohort 2a (VIR-3434 + TDF)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
STRIVE: Cohort 3a (VIR-3434 + TDF)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
STRIVE: Cohort 4a (VIR-3434 + VIR-2218 + TDF)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
STRIVE: Cohort 5a (VIR-3434 + VIR-2218 + TDF + PEG-IFNα)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
THRIVE: Cohort 1b (VIR-3434 + TDF)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
THRIVE: Cohort 2b (VIR-3434 + VIR-2218 + TDF)
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
STRIVE: Cohort 1a (VIR-3434 + TDF)
Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total
VIR-3434: VIR-3434 given by subcutaneous injection
TDF: TDF given orally
|
STRIVE: Cohort 2a (VIR-3434 + TDF)
Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total
VIR-3434: VIR-3434 given by subcutaneous injection
TDF: TDF given orally
|
STRIVE: Cohort 3a (VIR-3434 + TDF)
Participants will receive combination therapy with VIR-3434 + TDF for 36 or 40 weeks total
VIR-3434: VIR-3434 given by subcutaneous injection
TDF: TDF given orally
|
STRIVE: Cohort 4a (VIR-3434 + VIR-2218 + TDF)
n=16 participants at risk
Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 20 or 44 weeks total
VIR-3434: VIR-3434 given by subcutaneous injection
VIR-2218: VIR-2218 given by subcutaneous injection
TDF: TDF given orally
|
STRIVE: Cohort 5a (VIR-3434 + VIR-2218 + TDF + PEG-IFNα)
Participants will receive combination therapy with VIR-3434 + VIR-2218 +TDF + PEG-IFNα for 48 weeks total
VIR-3434: VIR-3434 given by subcutaneous injection
VIR-2218: VIR-2218 given by subcutaneous injection
TDF: TDF given orally
PEG-IFNα: PEG-IFNα given by subcutaneous injection
|
THRIVE: Cohort 1b (VIR-3434 + TDF)
Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks
VIR-3434: VIR-3434 given by subcutaneous injection
TDF: TDF given orally
|
THRIVE: Cohort 2b (VIR-3434 + VIR-2218 + TDF)
n=17 participants at risk
Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 44 weeks total
VIR-3434: VIR-3434 given by subcutaneous injection
VIR-2218: VIR-2218 given by subcutaneous injection
TDF: TDF given orally
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
5.9%
1/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
Other adverse events
| Measure |
STRIVE: Cohort 1a (VIR-3434 + TDF)
Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total
VIR-3434: VIR-3434 given by subcutaneous injection
TDF: TDF given orally
|
STRIVE: Cohort 2a (VIR-3434 + TDF)
Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total
VIR-3434: VIR-3434 given by subcutaneous injection
TDF: TDF given orally
|
STRIVE: Cohort 3a (VIR-3434 + TDF)
Participants will receive combination therapy with VIR-3434 + TDF for 36 or 40 weeks total
VIR-3434: VIR-3434 given by subcutaneous injection
TDF: TDF given orally
|
STRIVE: Cohort 4a (VIR-3434 + VIR-2218 + TDF)
n=16 participants at risk
Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 20 or 44 weeks total
VIR-3434: VIR-3434 given by subcutaneous injection
VIR-2218: VIR-2218 given by subcutaneous injection
TDF: TDF given orally
|
STRIVE: Cohort 5a (VIR-3434 + VIR-2218 + TDF + PEG-IFNα)
Participants will receive combination therapy with VIR-3434 + VIR-2218 +TDF + PEG-IFNα for 48 weeks total
VIR-3434: VIR-3434 given by subcutaneous injection
VIR-2218: VIR-2218 given by subcutaneous injection
TDF: TDF given orally
PEG-IFNα: PEG-IFNα given by subcutaneous injection
|
THRIVE: Cohort 1b (VIR-3434 + TDF)
Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks
VIR-3434: VIR-3434 given by subcutaneous injection
TDF: TDF given orally
|
THRIVE: Cohort 2b (VIR-3434 + VIR-2218 + TDF)
n=17 participants at risk
Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 44 weeks total
VIR-3434: VIR-3434 given by subcutaneous injection
VIR-2218: VIR-2218 given by subcutaneous injection
TDF: TDF given orally
|
|---|---|---|---|---|---|---|---|
|
General disorders
Injection site erythema
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
12.5%
2/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
5.9%
1/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
General disorders
Injection site mass
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
5.9%
1/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
General disorders
Injection site paraesthesia
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
5.9%
1/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
General disorders
Pain
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
5.9%
1/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
General disorders
Injection site pain
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
12.5%
2/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
General disorders
Immediate post-injection reaction
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
6.2%
1/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
General disorders
Injection site oedema
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
6.2%
1/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
General disorders
Injection site pruritus
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
6.2%
1/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
12.5%
2/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
11.8%
2/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Gastrointestinal disorders
Abdominal pain
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
5.9%
1/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
5.9%
1/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Gastrointestinal disorders
Gastritis
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
5.9%
1/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
5.9%
1/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Infections and infestations
COVID-19
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
6.2%
1/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
5.9%
1/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Infections and infestations
Pharyngitis
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
5.9%
1/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Infections and infestations
Upper respiratory tract infection
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
12.5%
2/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
5.9%
1/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Infections and infestations
Tracheitis
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
6.2%
1/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Eye disorders
Conjunctivitis allergic
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
5.9%
1/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Eye disorders
Vision blurred
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
5.9%
1/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Eye disorders
Excessive eye blinking
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
6.2%
1/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Gastrointestinal disorders
Abdominal distension
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
5.9%
1/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
General disorders
Chills
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
12.5%
2/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
11.8%
2/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
General disorders
Fatigue
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
12.5%
2/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
11.8%
2/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
General disorders
Pyrexia
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
6.2%
1/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
11.8%
2/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
General disorders
Feeling of body temperature change
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
5.9%
1/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
General disorders
Influenza like illness
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
23.5%
4/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Gastrointestinal disorders
Nausea
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
12.5%
2/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
5.9%
1/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Gastrointestinal disorders
Vomiting
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
12.5%
2/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
5.9%
1/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Gastrointestinal disorders
Abdominal discomfort
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
6.2%
1/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
6.2%
1/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Nervous system disorders
Headache
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
31.2%
5/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
11.8%
2/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Nervous system disorders
Tension headache
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
6.2%
1/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
12.5%
2/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
5.9%
1/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
5.9%
1/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
6.2%
1/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
5.9%
1/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Vascular disorders
Hypertension
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
11.8%
2/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
5.9%
1/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Blood and lymphatic system disorders
Neutropenia
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
6.2%
1/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
5.9%
1/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Hepatobiliary disorders
Hepatic cyst
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
5.9%
1/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
5.9%
1/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Investigations
Alpha 1 foetoprotein increased
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
18.8%
3/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Investigations
Alanine aminotransferase increased
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
5.9%
1/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Investigations
Aspartate aminotransferase increased
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
5.9%
1/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Investigations
Blood creatine phosphokinase increased
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
5.9%
1/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
|
Reproductive system and breast disorders
Ovarian cyst
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
0.00%
0/16 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
—
0/0 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
5.9%
1/17 • 48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators may present or publish results after: * the study results in their entirety have been publicly disclosed by or with the consent of the Sponsor OR study has been completed at all investigative sites for at least 2 years. * provision of publication 90 days before planned submission to allow Sponsor to remove confidential information or identify Sponsor intellectual property Publication may be delayed as applicable up to 6 months for Sponsor to file patent application(s)
- Publication restrictions are in place
Restriction type: OTHER