ARB-001467-002 Phase 2a HBeAg-Neg & Positive Subjects With Chronic HBV
Research type
Research Study
Full title
A Phase 2a, Single-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety, Anti-Viral Activity, and Pharmacokinetics of ARB-001467 in Non-Cirrhotic,HBeAg-Negative and Positive Subjects with Chronic HBV Infection Receiving Nucleos(t)ide Analogue Therapy
IRAS ID
194523
Contact name
Kosh Agarwal
Contact email
Sponsor organisation
Arbutus Biopharma Corporation
Eudract number
2015-005136-18
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 7 months, 0 days
Research summary
Hepatitis B virus (HBV) is the world’s most common serious liver infection. Approximately 350-400 million people are chronic (long-term) carriers of the virus. 25% of children who acquire HBV will develop liver cancer or cirrhosis (liver damage) as adults. Immigration patterns are increasing the incidence of HBV worldwide and the prevalence of chronic HBV has been observed, predominantly in the European Union and Middle East.
Current therapies of HBV act to provide long term control of viral replication and improve liver disease. However, this method has little effect in reducing levels of the hepatitis B surface antigen (HBsAg) in patients, meaning the virus is still present.The optimal strategy proposed for developing a cure for chronic HBV would be to target multiple aspects of the HBV lifecycle. It is anticipated that a long-term HBV cure will require combinations of therapy designed to address multiple targets simultaneously. ARB-001467 is a drug being developed to address these targets.
This study seeks to identify the best dose of ARB-001467 to use for future studies and to see if it has any effect on decreasing the HBV infection. The study will look at the safety and tolerability of the drug and any side effects or health problems it may cause. It will also investigate if the drug changes the HBV infection and how it behaves and is absorbed by the body.Patients eligible for this study will have chronic hepatitis B, will not have long-term liver damage (non-cirrhotic) and will have been receiving treatment with Entecavir or Tenofovir for at least 12 months. The study will be conducted at two NHS sites and is expected to last 13 months. Patients will be expected to make 21 visits to clinic throughout the study and will be given the drug by intravenous (IV) infusion at 3 visits.
REC name
London - South East Research Ethics Committee
REC reference
16/LO/0416
Date of REC Opinion
13 Apr 2016
REC opinion
Further Information Favourable Opinion