Evaluating ABI-H2158-Containing Regimens in Chronic Hep B Infection
Research type
Research Study
Full title
A Phase 2a, Multicenter, Single-Blind, Placebo-Controlled, Multiple Cohort Study Evaluating ABI-H2158-Containing Regimens in Chronic Hepatitis B Infection
IRAS ID
283499
Contact name
Kosh Agarwal
Contact email
Sponsor organisation
Assembly Biosciences
Eudract number
2019-004902-85
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 21 days
Research summary
Summary of Research
Chronic Hepatitis B Infection (CHB) is an infection of the liver caused by a virus called hepatitis B virus (HBV). HBV spreads through blood and body fluids. If the immune system is unable to get rid of the HBV and it remains in their blood and liver it is known as CHB. CHB affects over 240 million people and is a major cause of severe liver disease and liver-related death worldwide.ABI-H2158 is a new investigational drug being developed to treat CHB. ABI-H2158 works to prevent the spread of HBV in the body when used alongside a current approved treatment for CHB such as entecavir (ETV).
This aim of the study is to learn more about the safety and effects of ABI-H2158, when taken in combination with ETV for the treatment of patients with CHB who have never been treated for this infection or who have been treated for less than 4 weeks. This research study will also try to find out the best dose of ABI-H2158 to most effectively reduce HBV multiplication.
This study will also investigate and compare the effects of ABI-H2158 as compared to placebo (a dummy drug with no active ingredient) when taken in combination with ETV. Participants will have a 3 out of 4 (75%) chance of getting the study drug and a 1 out of 4 (25%) chance of getting placebo. Neither the participant nor study team will know who is receiving the study drug or placebo.
Approximately 80 participants, aged 18 - 65 years with CHB will participate in this study at approximately 50 study centres in North America, Europe, and Asia-Pacific regions.
This study involves procedures including: physical exam, vital signs, blood and urine tests, ECG (recording of the heart), medical history, medication and review of medications.
Summary of Results
The study was terminated early by the Sponsor due to ALT elevations consistent with drug-induced hepatotoxicity among subjects who received treatment with ABI-H2158.
Further clinical development of ABI-H2158 was terminated by the Sponsor due to this safety profile.REC name
London - Fulham Research Ethics Committee
REC reference
20/LO/1064
Date of REC Opinion
30 Oct 2020
REC opinion
Further Information Favourable Opinion