Efficacy of PegInterferon-Ribavirin-Boceprevir Therapy in Patients Infected With G1 HCV With Cirrhosis, Awaiting Liver Transplantation
NCT ID: NCT01463956
Last Updated: 2017-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
58 participants
INTERVENTIONAL
2012-01-06
2015-01-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Boceprevir, Pegylated interferon and Ribavirin
* Lead-in phase (4 week): Pegylated interferon + Ribavirin
* Triple therapy regimen for 44 weeks :Boceprevir + Pegylated interferon + Ribavirin
* Pegylated interferon + Ribavirin therapy until transplantation (less or equal to 24 weeks)
Boceprevir
Boceprevir 200 mg capsules at 2400mg/day (800mg 3 times a day) from week 4 until week 48 or until liver transplant (can be performed from week 16)
Peg-Interferon α-2b or Peg-Interferon α-2a
Peg-Interferon α-2b by subcutaneous injection, 1.5µg/kg/week, from day 0 until week 48 or until liver transplantation, or Peg-Interferon α-2a by subcutaneous injection, 180 µg, once weekly, from day 0 until week 48 or until liver transplantation
Ribavirin
Ribavirin: capsules 200 mg (weight-based daily dose: \<65kg, 800 mg; 65-80kg, 1000mg; 81-105kg: 1200mg; \>105kg: 1400mg), from day 0 until week 48 or until liver transplantation or, Ribavirin: Tablet Oral, weight-based dose, 1000 mg for subjects weighing below 75 kg or 1200 mg for subjects weighing equal or over75 kg, once daily, from day 0 until week 48 or until liver transplantation
Interventions
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Boceprevir
Boceprevir 200 mg capsules at 2400mg/day (800mg 3 times a day) from week 4 until week 48 or until liver transplant (can be performed from week 16)
Peg-Interferon α-2b or Peg-Interferon α-2a
Peg-Interferon α-2b by subcutaneous injection, 1.5µg/kg/week, from day 0 until week 48 or until liver transplantation, or Peg-Interferon α-2a by subcutaneous injection, 180 µg, once weekly, from day 0 until week 48 or until liver transplantation
Ribavirin
Ribavirin: capsules 200 mg (weight-based daily dose: \<65kg, 800 mg; 65-80kg, 1000mg; 81-105kg: 1200mg; \>105kg: 1400mg), from day 0 until week 48 or until liver transplantation or, Ribavirin: Tablet Oral, weight-based dose, 1000 mg for subjects weighing below 75 kg or 1200 mg for subjects weighing equal or over75 kg, once daily, from day 0 until week 48 or until liver transplantation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
French National Agency for Research on AIDS and Viral Hepatitis
OTHER_GOV
Responsible Party
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Principal Investigators
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Didier Samuel, Pr
Role: PRINCIPAL_INVESTIGATOR
Hepatobiliary Center of Paul Brousse Hospital. France
Locations
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Haut-Lévêque Hospital
Bordeaux, , France
Beaujon Hospital
Clichy, , France
Henri Mondor Hospital
Créteil, , France
A Michallon Hospital
Grenoble, , France
Claude Huriez hospital
Lille, , France
La Croix-Rousse
Lyon, , France
La Conception Hospital
Marseille, , France
Saint-Eloi Hospital
Montpellier, , France
Archet Hospital
Nice, , France
La Pitié Salpétrière Hospital
Paris, , France
Cochin Hospital
Paris, , France
Staint Antoine Hospital
Paris, , France
Pontchaillou Hospital
Rennes, , France
Civil Hospital
Strasbourg, , France
Purpan Hospital Médecine interne
Toulouse, , France
Purpan Hospital
Toulouse, , France
Trousseau Hospital
Tours, , France
Nancy Hospital
Vandœuvre-lès-Nancy, , France
Paul Brousse Hospital
Villejuif, , France
Countries
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Other Identifiers
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2011- 001089 -17
Identifier Type: -
Identifier Source: org_study_id
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