A Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection

• Status: Active, not recruiting
• Trial end date: 2023-01-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assembly Biosciences
• Treatments: Entecavir

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