Status:
COMPLETED
French Cohort of Therapeutic Failure and Resistances in Patients Treated With a Protease Inhibitor (Telaprevir or Boceprevir), Pegylated Interferon and Ribavirin
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18+ years
Brief Summary
The purpose fo the study is to evaluate the efficacy defined by the sustained virological response (SVR), in patients with compensated cirrhosis treated with PEG-IFN, RBV and telaprevir or boceprevir ...
Detailed Description
Methodology: Multicentric French national cohort with prospective collection of data and constitution of biobank, in HCV genotype 1 patients with compensated cirrhosis who failed to eradicate HCV with...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- patients who need the criteria of French Early Access Program for boceprevir and telaprevir or after the marketing authorization approval:
- patients aged of 18 years or more with chronic hepatitis C
- relapsers or partial-responders or null-responders to treatment with PEG'IFN α2a or 2b associated or not with RBV
- chronic infection with genotype 1 HCV
- fibrosis Metavir score of 4 (cirrhosis)
- without decompensated liver disease
- naïve of direct anti-viral treatment
- without HIV or HBV co-infection
- signature of participation to the cohort
Exclusion
Key Trial Info
Start Date :
February 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
675 Patients enrolled
Trial Details
Trial ID
NCT01514890
Start Date
February 1 2011
End Date
March 1 2014
Last Update
January 24 2017
Active Locations (1)
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1
Hôpital Henri Mondor
Créteil, France, 94000