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

Not Recruiting

Trial ID: NCT04398134

Purpose

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.

Official Title

A Phase 2a, Multicenter, Single-Blind, Placebo-Controlled, Multiple Cohort Study Evaluating ABI-H2158-Containing Regimens in Chronic Hepatitis B Infection

Stanford Investigator(s)

David S. Wang, MD

Clinical Associate Professor, Radiology

Paul Kwo
Paul Kwo

Professor of Medicine (Gastroenterology and Hepatology)

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

Intervention(s):

drug: ABI-H2158

drug: Placebo

drug: Entecavir (ETV)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jennifer Smart
650-721-8517