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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
162
Vesatolimod tablet administered orally
Placebo to match vesatolimod tablet administered orally
Unnamed facility
Los Angeles, California, United States
Unnamed facility
San Diego, California, United States
Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Level at Week 24
A mixed effect model for repeated measures (MMRM) was used to analyze HBsAg change from baseline, which included treatment, baseline HBsAg level (\> 5000 IU/mL or ≤ 5000 IU/mL), HBeAg baseline status (positive or negative), visit and treatment-by-visit interaction as fixed effect and visit as repeated measurement.
Time frame: Baseline to Week 24
Composite Endpoint Measuring the Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Loss and Seroconversion at Week 24
HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBeAg seroconversion was defined as qualitative hepatitis B envelope antibody (HBeAb) result changing from negative at baseline to positive at any postbaseline visit within the targeted time window. Participants who had missing information were assumed to have no HBeAg loss and no HBeAg seroconversion.
Time frame: Week 24
Composite Endpoint Measuring the Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Loss and Seroconversion at Week 48
HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBeAg seroconversion was defined as qualitative hepatitis B envelope antibody (HBeAb) result changing from negative at baseline to positive at any postbaseline visit within the targeted time window. Participants who had missing information were assumed to have no HBeAg loss and no HBeAg seroconversion. Only participants who were HBeAg+ at baseline were included.
Time frame: Week 48
Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and Seroconversion at Week 24
HBsAg loss was defined as qualitative HBsAg result changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBsAg seroconversion was defined as qualitative hepatitis B surface antibody (HBsAb) result changing from negative at baseline to positive at any postbaseline visit within the targeted time window. Participants who had missing information were assumed to have no HBsAg loss and no HBsAg seroconversion.
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Unnamed facility
San Francisco, California, United States
Unnamed facility
San Jose, California, United States
Unnamed facility
Honolulu, Hawaii, United States
Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
Detroit, Michigan, United States
Unnamed facility
Flushing, New York, United States
Unnamed facility
Vancouver, British Columbia, Canada
...and 13 more locations
Time frame: Week 24
Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and Seroconversion at Week 48
HBsAg loss was defined as qualitative HBsAg result changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBsAg seroconversion was defined as qualitative hepatitis B surface antibody (HBsAb) result changing from negative at baseline to positive at any postbaseline visit within the targeted time window. Participants who had missing information were assumed to have no HBsAg loss and no HBsAg seroconversion.
Time frame: Week 48
Change From Baseline in Serum HBsAg Level at Week 4
Time frame: Baseline; Week 4
Change From Baseline in Serum HBsAg Level at Week 8
Time frame: Baseline; Week 8
Change From Baseline in Serum HBsAg Level at Week 12
Time frame: Baseline; Week 12
Change From Baseline in Serum HBsAg Level at Week 48
Time frame: Baseline; Week 48