NCT00687219

Efficacy and Safety of Peginterferon Alfa-2b and Ribavirin Therapy in Subjects With Type C Compensated Liver Cirrhosis (Study P05116)

Treatment of Patients With Compensated Liver Cirrhosis With SCH 54031 + Ribavirin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The objective is to evaluate the efficacy and safety of combination therapy with peginterferon alfa-2b 1.0 µg/kg/week subcutaneous (SC) + ribavirin administered for 48 weeks in participants with chronic hepatitis C and type C compensated liver cirrhosis. Participants who are hepatitis C virus ribonucleic acid (HCV-RNA) positive after 24 weeks of treatment will be discontinued from therapy.

Conditions

• Hepatitis C, Chronic
• Liver Cirrhosis

Interventions

Type	Name	Description
BIOLOGICAL	Peginterferon alfa-2b	Administered at 1.0 µg/kg/week SC for 48 weeks
DRUG	Ribavirin	Administered based on body weight and hemoglobin value at Screening: 600-1000 mg/day for subjects with hemoglobin value at screening \>=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening \>=12g/dL and \<14g/dL; treatment duration is 48 weeks

Timeline

• Start date: 2007-06-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2008-05-30
• Last updated: 2017-04-07
• Results posted: 2011-12-02