A Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection
Trial ID or NCT#
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.
A Phase 2a, Multicenter, Single-Blind, Placebo-Controlled, Multiple Cohort Study Evaluating ABI-H2158-Containing Regimens in Chronic Hepatitis B Infection
- - 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
- - 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
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