Official Title
A Phase 2a, Multicenter, Single-Blind, Placebo-Controlled, Multiple Cohort Study Evaluating ABI-H2158-Containing Regimens in Chronic Hepatitis B Infection
Brief Title
A Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection
Protocol ID
NCT04398134
Lead Sponsor
Assembly Biosciences
Brief Summary
This Phase 2a study will assess the safety, antiviral activity, and pharmacokinetics (PK)
of ABI-H2158 administered once daily for up to 72 weeks in combination with entecavir
(ETV) in participants with chronic hepatitis B virus (HBV) infection.
Study Period
-
Enrollment Count
88 participants
Eligibility Criteria
Inclusion Criteria:
- Body mass index of 18 - 36 kg/m^2 and body weight ≥45 kg
- HBeAg ≥500 IU/mL at Screening
- In good general health except for chronic HBV infection for ≥6 months documented,
for example, by at least two measurements of HBsAg positivity and/or detectable HBV
DNA ≥6 months apart
- Lack of cirrhosis or advanced liver disease
Exclusion Criteria:
- Prior treatment for chronic HBV infection with lamivudine, telbivudine, adefovir,
standard of care nucleoside or nucleotide analogue (NrtI), HBV core inhibitors, or
an investigational agent for HBV infection
- History or evidence of advanced liver disease or hepatic decompensation (including
jaundice, ascites, portal hypertension, gastrointestinal bleeding, esophageal
varices, hepatic encephalopathy)
- History or presence of clinically significant medical conditions requiring frequent
medical management or pharmacologic or surgical treatment
Filters
Chronic Hepatitis B
PHASE2
TERMINATED
ADULT
OLDER_ADULT