NCT01463956

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

Pilot Study on the Efficacy of Pegylated Interferon-Ribavirin-Boceprevir Triple Therapy in Patients Infected With Genotype 1 HCV With Cirrhosis and Awaiting Liver Transplantation (ANRS HC 29 BOCEPRETRANSPLANT)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: French National Agency for Research on AIDS and Viral Hepatitis · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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-responders with cirrhosis and awaiting liver transplantation, with a MELD score less than or equal to 18

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 in patients with genotype 1, who are treatment-naive, have relapsed, or are non-responders with cirrhosis and awaiting liver transplantation, with a MELD score less than or equal to 18

Conditions

• HCV Infection
• Liver Cirrhosis, Experimental

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-01-06
• Primary completion: 2014-06-01
• Completion: 2015-01-22
• First posted: 2011-11-02
• Last updated: 2026-04-07

Locations

19 sites across 1 country: France