M14-567 - Study in Subjects with Genotype 3 Chronic HCV infection
Research type
Research Study
Full title
A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of the Co-Administration of Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) With Sofosbuvir (SOF) With or Without Ribavirin (RBV) in Subjects With Genotype 3 Chronic Hepatitis C Virus (HCV) Infection
IRAS ID
163563
Contact name
Kaushik Agarwal
Contact email
Sponsor organisation
AbbVie
Eudract number
2014-003147-35
Duration of Study in the UK
1 years, 5 months, 27 days
Research summary
Hepatitis C infection is the most common chronic liver disease worldwide. The Hepatitis C virus predominantly affects liver cells and causes the liver to become inflamed and damaged. This can lead to cirrhosis (scarring of the liver) and liver cancer, and patients may then need a liver transplant.
Treatment options for Hepatitis C infection are limited for patients. Drug companies are developing drugs called ‘Direct-Acting Antiviral Agents’ (DAAs) which work by targeting the different stages of the virus lifecycle. DAAs provide an alternative option to injectable therapies for Hepatitis C patients.
This study will test two of AbbVie’s DAA drugs (ABT-450 and ombitasvir, combined into one tablet with another drug called ritonavir) in combination with another medication called sofosbuvir to check that they are safe and effective for patients with Hepatitis C who have the Genotype 3 strain of the virus.
Subjects could be eligible for this study if they have Hepatitis C without cirrhosis and have either never been treated or have been treated but that treatment was not effective. The study will be conducted in two hospital clinics in the UK.
Subjects will attend regular study visits at clinics over a 65 week period. The effect of the treatments on the virus will be checked by performing blood tests and collecting general medical health information.
REC name
London - Dulwich Research Ethics Committee
REC reference
14/LO/1927
Date of REC Opinion
16 Dec 2014
REC opinion
Further Information Favourable Opinion