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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-A01273-36 | Other Identifier | AFSSAPS |
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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.
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:
Estimated planning:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telaprevir | |||
| Boceprevir |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of sustained virological response (SVR) defined by an undetectable RNA by real-time PCR. | 6 months after discontinuation of therapy (at week 72) |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria:
patients who need the criteria of French Early Access Program for boceprevir and telaprevir or after the marketing authorization approval:
signature of participation to the cohort
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Patients with chronic hepatitis C in genotype 1 Who Failed to Eradicate HCV With a Previous Standard PEG-IFN and RBV Combination
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| Name | Affiliation | Role |
|---|---|---|
| Christophe HEZODE | GHU H. Mondor | Principal Investigator |
| Fabrice CARRAT, Methodologist | Unité INSERM 707 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Henri Mondor | Créteil | 94000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25556540 | Derived | 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. | |
| 24704719 |
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whole blood
| at D0, W4, W8, W12, W24, W48 and 12 (W60) and 24 (W72) weeks after the discontinuation of treatment |
| early viral kinetic | at the D0, W1, W2 and W4 |
| Rate of premature discontinuation of protease inhibitor, RBV and/or PEG-IFN | 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) | in may 2014 (3 month after study completion date) |
| Evolution of quality of life scores | in may 2014 (3 month after study completion date) |
| Evaluation of therapeutic observance with auto-questionnaires | in may 2014 (3 month after study completion date) |
| Rate of adaptation of dosage of protease inhibitors, RBV and/or PEG-IFN | in may 2014 (3 month after study completion date) |
| Derived |
| 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. |
| 23669289 | Derived | 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. |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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