Conditions: Chronic Hepatitis B
Keywords: Hepatitis B HBV GS-9620 TLR-7 Agonist
Allocation: RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 162
Healthy volunteers: no

Brief summary:
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of vesatolimod in participants with chronic hepatitis B (CHB) infection currently being treated with oral antivirals (OAV).

Participants will be randomized in 3 sequential cohorts (Cohorts A, B, and C). Within each cohort, participants will be randomized in a 1:3:3:3 ratio to placebo or one of the doses of vesatolimod (1, 2, or 4 mg).

Detailed description:

Arms:
arm 1: Placebo tablet once a week for 4 weeks arm 2: Vesatolimod 1 mg tablet once a week for 4 weeks arm 3: Vesatolimod 2 mg tablet once a week for 4 weeks arm 4: Vesatolimod 4 mg tablet once a week for 4 weeks arm 5: Placebo tablet once a week for 8 weeks arm 6: Vesatolimod 1 mg tablet once a week for 8 weeks arm 7: Vesatolimod 2 mg tablet once a week for 8 weeks arm 8: Vesatolimod 4 mg tablet once a week for 8 weeks arm 9: Placebo tablet once a week for 12 weeks arm 10: Vesatolimod 1 mg tablet once a week for 12 weeks arm 11: Vesatolimod 2 mg tablet once a week for 12 weeks arm 12: Vesatolimod 4 mg tablet once a week for 12 weeks

Interventions: intervention 1: Vesatolimod intervention 2: Placebo
Intervention descriptions: intervention 1: Vesatolimod tablet administered orally intervention 2: Placebo to match vesatolimod tablet administered orally

Protocol document: