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CompletedNCT01514890CUPICUpdated Jan 24, 2017

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

An observational study in Chronic Hepatitis C, sponsored by ANRS, Emerging Infectious Diseases. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-24.

Sponsored by ANRS, Emerging Infectious Diseases · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
675
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Chronic Hepatitis C
03

In context

Hepatitis C

2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.

This study's enrollment of 675 is above the median of 244 across 567 observational studies indexed under Hepatitis C.

Browse Hepatitis C studies →

Lead sponsor

ANRS, Emerging Infectious Diseases is the lead sponsor of 212 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
675 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Telaprevir
  • Boceprevir
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What researchers measure

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

    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)

    Time frame: at D0, W4, W8, W12, W24, W48 and 12 (W60) and 24 (W72) weeks after the discontinuation of treatment

  2. early viral kinetic

    Time frame: at the D0, W1, W2 and W4

  3. Rate of premature discontinuation of protease inhibitor, RBV and/or PEG-IFN

    Time frame: in may 2014 (3 month after study completion date)

  4. 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)

  5. Evolution of quality of life scores

    Time frame: in may 2014 (3 month after study completion date)

  6. Evaluation of therapeutic observance with auto-questionnaires

    Time frame: in may 2014 (3 month after study completion date)

  7. Rate of adaptation of dosage of protease inhibitors, RBV and/or PEG-IFN

    Time frame: in may 2014 (3 month after study completion date)

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Study locations

1 site
  • Hôpital Henri Mondor
    Créteil, 94000, France
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References and documents

Publications

  • Sultanik P, Mallet V, Lagaye S, Casrouge A, Dorival C, Barthe Y, Fontaine H, Hezode C, Mottez E, Bronowicki JP, Carrat F, Theodorou I, Abel L, Gayat E, Fontanet A, Pol S, Albert ML; ANRS CO20-CUPIC. Plasma apolipoprotein H limits HCV replication and associates with response to NS3 protease inhibitors-based therapy. Liver Int. 2015 Jul;35(7):1833-44. doi: 10.1111/liv.12759. Epub 2015 Jan 23. PubMed 25556540 ↗
  • Hezode C, Fontaine H, Dorival C, Zoulim F, Larrey D, Canva V, De Ledinghen V, Poynard T, Samuel D, Bourliere M, Alric L, Raabe JJ, Zarski JP, Marcellin P, Riachi G, Bernard PH, Loustaud-Ratti V, Chazouilleres O, Abergel A, Guyader D, Metivier S, Tran A, Di Martino V, Causse X, Dao T, Lucidarme D, Portal I, Cacoub P, Gournay J, Grando-Lemaire V, Hillon P, Attali P, Fontanges T, Rosa I, Petrov-Sanchez V, Barthe Y, Pawlotsky JM, Pol S, Carrat F, Bronowicki JP; CUPIC Study Group. Effectiveness of telaprevir or boceprevir in treatment-experienced patients with HCV genotype 1 infection and cirrhosis. Gastroenterology. 2014 Jul;147(1):132-142.e4. doi: 10.1053/j.gastro.2014.03.051. Epub 2014 Apr 3. PubMed 24704719 ↗
  • Hezode C, Fontaine H, Dorival C, Larrey D, Zoulim F, Canva V, de Ledinghen V, Poynard T, Samuel D, Bourliere M, Zarski JP, Raabe JJ, Alric L, Marcellin P, Riachi G, Bernard PH, Loustaud-Ratti V, Metivier S, Tran A, Serfaty L, Abergel A, Causse X, Di Martino V, Guyader D, Lucidarme D, Grando-Lemaire V, Hillon P, Feray C, Dao T, Cacoub P, Rosa I, Attali P, Petrov-Sanchez V, Barthe Y, Pawlotsky JM, Pol S, Carrat F, Bronowicki JP; CUPIC Study Group. Triple therapy in treatment-experienced patients with HCV-cirrhosis in a multicentre cohort of the French Early Access Programme (ANRS CO20-CUPIC) - NCT01514890. J Hepatol. 2013 Sep;59(3):434-41. doi: 10.1016/j.jhep.2013.04.035. Epub 2013 May 10. PubMed 23669289 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01514890
Lead sponsor
ANRS, Emerging Infectious Diseases
Responsible party
Sponsor
First posted
Jan 23, 2012
Start date
Feb 2011
Primary completion
Mar 2014
Completion
Mar 2014
Last update
Jan 24, 2017

Study contacts

Christophe HEZODE
principal investigator · GHU H. Mondor
Fabrice CARRAT, Methodologist
study chair · Unité INSERM 707

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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