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A Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection
Recruiting
I'm InterestedTrial 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
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)
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Jennifer Smart
650-721-8517