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

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

Recruiting
18-65 years
All
Phase 2

Overview

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.

Eligibility

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

Study details
    Hepatitis B
    Hepatitis B
    chronic hepatitis b

NCT04398134

Assembly Biosciences

5 August 2020

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