M12-999: Chronic HCV infection in adult liver transplant recipients
Research type
Research Study
Full title
Open-label, Phase 2 Study to Evaluate the Safety and Efficacy of the Combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adult Transplant Recipients with Genotype 1 Hepatitis C Virus (HCV) Infection (CORAL-I).
IRAS ID
147024
Contact name
Kaushik Agarwal
Contact email
Eudract number
2012-004792-39
Clinicaltrials.gov Identifier
Research summary
Hepatitis C infection is among the most common chronic liver diseases worldwide and it is a leading cause of liver transplant in the UK. A liver transplant does not usually cure the infection, and the new liver can also become damaged by the Hepatitis C virus. Approximately 11%-49% of renal (kidney) transplant recipients test positive for anti-HCV, which means that they have been infected with the Hepatitis C virus.
Treatment options for Hepatitis C infection are very limited for patients once they have had a transplant.
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 therapy option for transplant patients.
AbbVie has three DAAs in development (ABT-450/r, ABT -267 and) ABT -333). This study will test the drugs in combination to check that they are safe and effective for patients with Hepatitis C who have received a liver or renal (kidney_ transplant. Subjects who have Hepatitis C and have either never had treatment or have taken medications to treat Hepatitis C but they were not effective could be eligible to take part in this study. The study will be conducted in one hospital clinic in the UK.
Subjects will attend regular study visits at clincis over a 77 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 - South East Research Ethics Committee
REC reference
14/LO/0397
Date of REC Opinion
1 May 2014
REC opinion
Further Information Favourable Opinion