Status:
TERMINATED
A Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection
Lead Sponsor:
Assembly Biosciences
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2021
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT04398134
Start Date
August 28 2020
End Date
December 28 2021
Last Update
September 15 2022
Active Locations (44)
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1
Coalition of Inclusive Medicine
Los Angeles, California, United States, 90020
2
California Liver Research Institute
Pasadena, California, United States, 91105
3
Stanford University Medical Center
Redwood City, California, United States, 94063
4
Research and Education Inc.
San Diego, California, United States, 92105