TOPAZ I- study in ABT-450/Ritonavir/ABT-267 and ABT-333 in chronic HCV
Research type
Research Study
Full title
An Open-Label, Multicenter Study to Evaluate Long-Term Outcomes With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ-I)
IRAS ID
162210
Contact name
Stephen Ryder
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2014-001022-14
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 1 months, 25 days
Research summary
Chronic Hepatitis C viral (HCV) infection is a global health problem affecting 170 million people worldwide. The virus mainly infects liver cells and chronic infection can lead to cirrhosis (scar tissue building up in the liver) and cancer of the liver.
Successful treatment of HCV with existing therapies is known to reduce the risk of these complications. The use of combinations of Direct Acting Antiviral agents (DAAs) target different steps of the virus lifecycle. DAAs have the potential to significantly improve treatment by increasing the safety and shortening the duration of treatment as compared to current treatment regimens that may contain pegylated interferon.
AbbVie’s IFN free 3 DAA regimen (ABT450/r/ABT267and ABT333) has been tested in over 2300 patients in several Phase 3 clinical trials, and appears to be safe, well tolerated and effective (as judged by the accepted method of inability to detect HCV in blood 12 weeks after the end of treatment which is called Sustained Virologic Response (SVR)). This study is designed to both treat patients and to prove the durability of the response with long-term follow up. It will also establish if liver related problems are avoided in those with successful treatment.
This study will evaluate Long-term predefined clinical outcomes following treatment with ABT450/ r/ABT267 and ABT333 with or without RBV in adults with genotype 1 Chronic Hepatitis C Virus (HCV) infection for 12 or 24 weeks.
Participants will then be followed up for up to 5 years. Procedures include: vital signs, electrocardiograms, liver ultrasound, liver biopsy, CT/MRI scans, urine and blood samples for laboratory tests and questionnaires to monitor the disease or side effects of the drug.
This study is being sponsored by AbbVie, approximately 1650 participants will take part in the study, approximately 105 participants in the UK.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
14/EM/1249
Date of REC Opinion
7 Jan 2015
REC opinion
Further Information Favourable Opinion