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French Cohort of Therapeutic Failure and Resistances in Patients Treated With a Protease Inhibitor (Telaprevir or Boceprevir), Pegylated Interferon and Ribavirin (CUPIC)

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ClinicalTrials.gov Identifier: NCT01514890
Recruitment Status : Completed
First Posted : January 23, 2012
Last Update Posted : January 24, 2017
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Tracking Information
First Submitted Date January 18, 2012
First Posted Date January 23, 2012
Last Update Posted Date January 24, 2017
Actual Study Start Date February 2011
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 20, 2012)
Rate of sustained virological response (SVR) defined by an undetectable RNA by real-time PCR. [ Time Frame: 6 months after discontinuation of therapy (at week 72) ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01514890 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 20, 2012)
  • Virological response during and after the treatment with determination of HCV RNA levels as prevised by the French Early Access Program for the use of protease inhibitors and after the approval. [ Time Frame: at D0, W4, W8, W12, W24, W48 and 12 (W60) and 24 (W72) weeks after the discontinuation of treatment ]
    This will allow to define:
    • rate of non response (detectable RNA during the treatment)
    • rate of virological breakthrough (undetectable HCV RNA then detectable during the treatment)
    • rate of virological relapse after the discontinuation of treatment (undetectable HCV RNA at the end of therapy then detectable after the treatment)
  • early viral kinetic [ Time Frame: at the D0, W1, W2 and W4 ]
  • Rate of premature discontinuation of protease inhibitor, RBV and/or PEG-IFN [ Time Frame: in may 2014 (3 month after study completion date) ]
  • occurrence of resistant mutants in partial responders (detectable RNA) or after the occurrence of virological breakthrough and long term evolution of these mutations (on serum bank) [ Time Frame: in may 2014 (3 month after study completion date) ]
  • Evolution of quality of life scores [ Time Frame: in may 2014 (3 month after study completion date) ]
  • Evaluation of therapeutic observance with auto-questionnaires [ Time Frame: in may 2014 (3 month after study completion date) ]
  • Rate of adaptation of dosage of protease inhibitors, RBV and/or PEG-IFN [ Time Frame: in may 2014 (3 month after study completion date) ]
Original Secondary Outcome Measures Same as current
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title French Cohort of Therapeutic Failure and Resistances in Patients Treated With a Protease Inhibitor (Telaprevir or Boceprevir), Pegylated Interferon and Ribavirin
Official Title Cohort of Therapeutic Failure and Resistances in Patients Treated With a Protease Inhibitor (Telaprevir or Boceprevir), Pegylated Interferon (PEG-IFN) and Ribavirin (RBV) Included in the French Early Access Program for the Use of Protease Inhibitors in Genotype 1 Patients Who Failed to Eradicate HCV With a Previous Standard PEG-IFN and RBV Combination.
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 in the French Early Access Program for the use of protease inhibitors or after the approval of these drugs through the the marketing authorization.
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 the combination PEG-IFN and RBV, treated with protease inhibitor (telaprevir or boceprevir), PEG-IFN and RBV, included in the French Early Access Program for the use of protease inhibitors or after approval of these drugs through the the marketing authorization.

Primary objective: Evaluate the efficacy defined by the sustained virological response (SVR), in patients with compensated cirrhosis treated with PEG-IFN, RBV and telaprevir or boceprevir in the French Early Access Program for the use of protease inhibitors or after the approval of these drugs.

Estimated enrollment: 900 patients treated in the French Early Access Program for the use of protease inhibitors and after the marketing authorization approval.

Treatments:

  • with telaprevir: triple combination with PEG-IFN alfa-2a, 180 µg/week, ribavirin 1000 to 1200 mg/d according the body weight and telaprevir 750 mg/8h, for 12 weeks followed by PEG-IFN and RBV for 36 weeks for a total duration of treatment of 48 weeks.
  • or with boceprevir: triple combination with PEG-IFN alfa-2b, 1,5 µg/kg/week, RBV 800 to 1400 mg/d according the body weight and boceprevir 800 mg/8h. The treatment will begin after a lead in phase of PEG-IFN and RBV for 4 weeks, followed by a triple combination (PEG-IFN, RBV and boceprevir)during 44 weeks for a total duration of treatment of 48 weeks.

Estimated planning:

  • study start date: February 2011
  • enrollment period: 14 months
  • subject participation duration: 12 months of treatment and 12 months of follow-up = 24 months
  • total study duration: 38 months. The last visit of the last enrolled patient is prevised in February 2014, the end of analysis on biobank in May 2014 (long term follow up of resistant mutants).

Some blood samples will be preserved for scientific future research.

Study design: national French multicentric cohort in patients with HCV-related cirrhosis treated in the French Early Access Program for the use of boceprevir or telaprevir or after the marketing authorization approval of these drugs associated with PEG-IFN and RBV with a collection of clinical and biological data and constitution of a biobank.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood
Sampling Method Probability Sample
Study Population Patients with chronic hepatitis C in genotype 1 Who Failed to Eradicate HCV With a Previous Standard PEG-IFN and RBV Combination
Condition Chronic Hepatitis C
Intervention Not Provided
Study Groups/Cohorts
  • Telaprevir
  • Boceprevir
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 26, 2012)
675
Original Estimated Enrollment
 (submitted: January 20, 2012)
900
Actual Study Completion Date March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01514890
Other Study ID Numbers ANRS CO20
2010-A01273-36 ( Other Identifier: AFSSAPS )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Study Sponsor French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Collaborators Not Provided
Investigators
Principal Investigator: Christophe HEZODE GHU H. Mondor
Study Chair: Fabrice CARRAT, Methodologist Unité INSERM 707
PRS Account French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Verification Date January 2017