Trial Search Results

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

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Assembly Biosciences

Stanford Investigator(s):

Intervention(s):

  • Drug: ABI-H2158
  • Drug: Placebo
  • Drug: Entecavir (ETV)

Phase:

Phase 2

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

Ages Eligible for Study

18 Years - 65 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

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