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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Chronic Hepatitis B

In brief

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.

Key facts

Study ID

NCT04398134

Run by

Assembly Biosciences

People needed

88

Starts

2020-08-28

Expected to finish

2021-12-28

Last updated by the study team

2022-09-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Coalition of Inclusive Medicine — Los Angeles, California, United States
• California Liver Research Institute — Pasadena, California, United States
• Stanford University Medical Center — Redwood City, California, United States
• Research and Education Inc. — San Diego, California, United States
• Quest Clinical Research — San Francisco, California, United States
• University of Miami/Schiff Center for Liver Diseases — Miami, Florida, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• New Discovery, LLC — Flushing, New York, United States
• Northwell Health Center for Liver Disease — Manhasset, New York, United States
• NYU Langone Health — New York, New York, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• American Research Corporation at the Texas Liver Institute — San Antonio, Texas, United States
• University of Washington — Seattle, Washington, United States
• Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
• St. Vincent's Hospital — Darlinghurst, New South Wales, Australia
• John Hunter Hospital — New Lambton, New South Wales, Australia
• Gallipoli Medical Research Foundation — Greenslopes, Queensland, Australia
• St. Vincent's Hospital — Fitzroy, Victoria, Australia
• Alfred Hospital — Melbourne, Victoria, Australia
• Melbourne Health — Parkville, Victoria, Australia
• (G.I.R.I.) GI Research Institute — Vancouver, British Columbia, Canada
• Toronto Liver Centre — Toronto, Ontario, Canada
• The First Hospital of Jilin University — Changchun, Jilin, China
• The Second Affliated Hospital of Chongqing Medical University — Chongqing, Yuzhong District, China
• Xiangya Hospital Central South University — Changsha, China

Full record on ClinicalTrials.gov

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