Phase 2a study evaluating ABI-H0731 for treatment of chronic hep B
Research type
Research Study
Full title
A Phase 2a Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731 + Entecavir vs. Entecavir alone for the Treatment of Viremic, HBeAg-positive Patients with Chronic Hepatitis B
IRAS ID
248424
Contact name
Kosh Agarwal
Contact email
Sponsor organisation
Assembly Biosciences, Inc.
Eudract number
2018-002042-36
Clinicaltrials.gov Identifier
IND, 136780
Duration of Study in the UK
0 years, 9 months, 1 days
Research summary
Chronic hepatitis B infection (CHB) is a major global cause of severe liver morbidity and liver-related mortality. This is due to the inflammation in the liver which can lead to severe liver disease, liver cancer or death in some patients. Current treatments for CHB can suppress the infection and the liver disease in many patients. However, without long term treatment or re-treatment, the current treatments lead to a lasting benefit in only a small portion of patients.
ABI-H0731 (the study medication) is an experimental medication developed by the Sponsor of this study. A Phase 1a/1b study has shown ABI-H0731 to be safe and to have an antiviral effect (stops the spread of virus) in patients with CHB when given for up to 28 days. ABI-H0731 has the potential to be an effective treatment for chronic HBV infection and potentially lower the amount of HBV even lower than existing medications (entecavir) on their own.
The purpose of this research study is to determine the safety and antiviral effects of ABI-H0731 when taken together with entecavir, a standard of care medication for men and women with chronic HBV infection. This is a Phase 2a, multi-centre, randomised, double-blind, placebo-controlled study. Participants will be randomised 1:1 to receive ABI-H0731 or matching placebo as add-on therapy to Entecavir.
Approximately 24 participants, aged 18 to 70, globally will participate in this research study. The study will be split in phases, including up to 45 days for screening, 6 months for treatment and 3 months follow-up. During the study treatment period, participants will visit the clinics 8 times, with two additional follow-up visits. Study procedures include, but are not limited to, ECGs; liver screening by Biopsy, fasting FibroScan, MRI or liver ultrasound; blood and urine samples; physical examinations and questionnaires.
REC name
London - Hampstead Research Ethics Committee
REC reference
18/LO/1270
Date of REC Opinion
3 Aug 2018
REC opinion
Favourable Opinion