Status:
COMPLETED
Efficacy of PegInterferon-Ribavirin-Boceprevir Therapy in Patients Infected With G1 HCV With Cirrhosis, Awaiting Liver Transplantation
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HCV Infection
Liver Cirrhosis, Experimental
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Evaluation of efficacy of triple therapy with pegylated interferon, ribavirin, and boceprevir in patients with genotype 1 chronic hepatitis C, who are treatment-naive, have relapsed, or are non-respon...
Detailed Description
Evaluation of sustained virological response defined as the proportion of patients with undetectable hepatitis C virus RNA 24 weeks after discontinuation of therapy and/or after liver transplantation ...
Eligibility Criteria
Inclusion
- Adult 18 years and older
- Chronic infection with hepatitis C virus proven with positive PCR for more than 6 months
- Viral genotype 1
- Cirrhosis while awaiting liver transplantation
- MELD score \< or equal to 18
- With or without hepatocellular carcinoma
- Naive to antiviral C treatment
- Failure on a previous treatment. Failure is defined as the persistence of detectable HCV RNA. The previous HCV failure treatment profile must be able to be documented according to the following terminology:- Relapsing patient: HCV RNA undetectable at the end of treatment, becoming detectable again after the discontinuation of treatment- Breakthrough: increase of viremia of 1 log or more during the treatment - Non-responding patient with partial response: HCV RNA detectable at W24 without ever having been undetectable and with a decrease in HCV RNA ≥ 2 log at W12 - Non-responding patient with nul response: decrease in HCV RNA \< 2 log at W12
- No need for prior treatment wash-out
- Negative pregnancy test in women of child-bearing age
- Double method of contraception in men and women of child-bearing age during the entire duration of treatment and the 6 months following its discontinuation
- Free, informed, and written consent (signed on the day of pre-enrollment at the latest and before all exams required by the study)
- Person enrolled in or a beneficiary of a social security/Universal Health Insurance Coverage
- Inclusion approved by the Decision Support Committee
Exclusion
- Previous HCV treatment with boceprevir or telaprevir
- Alcohol consumption \> 40 g/day
- Toxicomania constituting a barrier for starting therapy according to the opinion of the investigator. Patients included in a methadone or buprenorphine replacement program may be enrolled
- MELD \> 18
- Non controlled sepsis
- Platelets \< 50,000/mm3
- Neutrophil granulocyte levels \< 1000/mm3
- Creatinine clearance \< 50 mL/min (MDRD)
- Hb \< 10 g/dL
- Uncontrolled psychiatric problems
- Contraindications to boceprevir
- Contraindication to interferon or ribavirin
- Subject with major complications of cirrhosis
- HIV coinfection
- HBV coinfection (unless this is treated effectively with analogues, as proven by undetectable viremia for at least 12 months)
- Other infectious disease underway
- Neoplastic disease other than hepatocellular carcinoma during the previous year, or neoplastic disease for which the prognosis is less than 3 years
- Treatment with immunosuppressors (including corticosteroids), antivirals other than those for the study, except aciclovir
- Consumption of St. John's wort
- Associated treatments including a molecule or substance that could interfere with the pharmacokinetic characteristics of boceprevir
- History of a lactose allergy
- Person participating in another study including an exclusion period that is still underway during pre-enrollment
- So-called vulnerable populations (minors, people under guardianship or protection, or a private individual under protection from making legal or administrative decisions)
- Pregnancy, breast-feeding
Key Trial Info
Start Date :
January 6 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2015
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT01463956
Start Date
January 6 2012
End Date
January 22 2015
Last Update
January 24 2017
Active Locations (19)
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1
Haut-Lévêque Hospital
Bordeaux, France, 33601
2
Beaujon Hospital
Clichy, France, 92110
3
Henri Mondor Hospital
Créteil, France, 94010 Cedex
4
A Michallon Hospital
Grenoble, France, 38700