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

Trial ID or NCT#

NCT04398134

Status

recruiting iconRECRUITING

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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

Investigator(s)

Paul Kwo
Paul Kwo
Hepatologist, Transplant hepatologist, Gastroenterologist
Professor of Medicine (Gastroenterology and Hepatology)
David S. Wang, MD
Interventional radiologist, Radiologist, Minimally invasive surgeon, Diagnostic radiologist
Clinical Associate Professor, Radiology

Contact us to find out if this trial is right for you.

Contact

Jennifer Smart
650-721-8517