Efficacy of PegInterferon-Ribavirin-Boceprevir Therapy in Patients Infected With G1 HCV With Cirrhosis, Awaiting Liver Transplantation

PHASE2CompletedINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

January 6, 2012

Primary Completion Date

June 30, 2014

Study Completion Date

January 22, 2015

Conditions
HCV InfectionLiver Cirrhosis, Experimental
Interventions
DRUG

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)

BIOLOGICAL

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

DRUG

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

Trial Locations (19)

13285

La Conception Hospital, Marseille

33601

Haut-Lévêque Hospital, Bordeaux

34090

Saint-Eloi Hospital, Montpellier

37044

Trousseau Hospital, Tours

38700

A Michallon Hospital, Grenoble

54500

Nancy Hospital, Vandœuvre-lès-Nancy

75013

La Pitié Salpétrière Hospital, Paris

75014

Cochin Hospital, Paris

92110

Beaujon Hospital, Clichy

94010 Cedex

Henri Mondor Hospital, Créteil

59037 cedex

Claude Huriez hospital, Lille

69 317 CEDEX

La Croix-Rousse, Lyon

06202 cedex 3

Archet Hospital, Nice

75571 Cedex 12

Staint Antoine Hospital, Paris

35033 cedex 9

Pontchaillou Hospital, Rennes

67091 Cedex

Civil Hospital, Strasbourg

31059 cedex

Purpan Hospital Médecine interne, Toulouse

Purpan Hospital, Toulouse

94804 cedex

Paul Brousse Hospital, Villejuif

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

French National Agency for Research on AIDS and Viral Hepatitis

OTHER_GOV

NCT01463956 - Efficacy of PegInterferon-Ribavirin-Boceprevir Therapy in Patients Infected With G1 HCV With Cirrhosis, Awaiting Liver Transplantation | Biotech Hunter | Biotech Hunter