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

This study is ongoing, but not recruiting participants.
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)
ClinicalTrials.gov Identifier:
NCT01514890
First received: January 18, 2012
Last updated: December 26, 2012
Last verified: December 2012
  Purpose

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.


Condition
Chronic Hepatitis C

Study Type: Observational
Study Design: Observational Model: Cohort
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.

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
  • Rate of premature discontinuation of protease inhibitor, RBV and/or PEG-IFN [ Time Frame: in may 2014 (3 month after study completion date) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: No ]
  • Evolution of quality of life scores [ Time Frame: in may 2014 (3 month after study completion date) ] [ Designated as safety issue: No ]
  • Evaluation of therapeutic observance with auto-questionnaires [ Time Frame: in may 2014 (3 month after study completion date) ] [ Designated as safety issue: No ]
  • Rate of adaptation of dosage of protease inhibitors, RBV and/or PEG-IFN [ Time Frame: in may 2014 (3 month after study completion date) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood


Enrollment: 675
Study Start Date: February 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Telaprevir
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01514890

Locations
France
Hôpital Henri Mondor
Créteil, France, 94000
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Investigators
Principal Investigator: Christophe HEZODE GHU H. Mondor
Study Chair: Fabrice CARRAT, Methodologist Unité INSERM 707
  More Information

No publications provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT01514890     History of Changes
Other Study ID Numbers: ANRS CO20, 2010-A01273-36
Study First Received: January 18, 2012
Last Updated: December 26, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Flaviviridae Infections
Hepatitis
Hepatitis, Viral, Human
Liver Diseases
RNA Virus Infections
Virus Diseases
HIV Protease Inhibitors
Protease Inhibitors
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014