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

Assembly Biosciences

Status and phase

Terminated

Phase 2

Conditions

Chronic Hepatitis B

Treatments

Drug: ABI-H2158

Drug: Entecavir (ETV)

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04398134

ABI-H2158-201

2019-004902-85 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

88 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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