Simeprevir and Daclastasvir in Hep-C Advanced Liver Disease - COMMIT
Research type
Research Study
Full title
A Phase 2, Open-label Study to Investigate the Efficacy and Safety of the Combination of Simeprevir and Daclatasvir in Chronic Hepatitis C Genotype 1b-Infected Subjects With Advanced Liver Disease
IRAS ID
167071
Contact name
Ashley Brown
Contact email
Sponsor organisation
Global Clinical Operations; Janssen Research and Development
Eudract number
2014-003413-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 17 days
Research summary
This is an open-label, multicentre, Phase 2 study to determine the efficacy, safety, and tolerability of treatment with simeprevir 150 mg once daily in combination with daclatasvir 60 mg once daily with approximately 110 participants who are infected with hepatitis C virus (genotype 1b)[HCV] who are treatment naïve and have advanced fibrosis or compensated cirrhosis of the liver. All participants will receive open-label study drug (simeprevir and daclatasvir) for 12 weeks and all participants will be followed at post-treatment visits until Week 24 after actual End of Treatment (EOT), except those who withdraw consent or initiate other HCV treatment. The duration of participation for an individual subject, including the screening period, will be approximately 40 weeks.
Efficacy will be evaluated by monitoring plasma Hepatitis-C virus levels. Safety evaluations will include the monitoring of adverse events, clinical laboratory test results, vital sign measurements, and physical examinations.
Blood samples for hepatitis C virus analysis to identify genetic variations will be collected at screening and all scheduled visits. Additional blood samples will be collected for pharmacokinetic evaluations.
REC name
London - City & East Research Ethics Committee
REC reference
14/LO/2125
Date of REC Opinion
9 Mar 2015
REC opinion
Further Information Favourable Opinion