Efficacy and Safety of Peginterferon Alfa-2b and Ribavirin Therapy in Subjects With Type C Compensated Liver Cirrhosis (Study P05116)
This study has been completed.
Merck Sharp & Dohme Corp.
First Posted: May 30, 2008
Last Update Posted: April 7, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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.
|Hepatitis C, Chronic Liver Cirrhosis||Biological: Peginterferon alfa-2b Drug: Ribavirin||Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Treatment of Patients With Compensated Liver Cirrhosis With SCH 54031 + Ribavirin|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Number of Participants With Undetectable HCV-RNA at Week 72 (Sustained Virologic Response) [ Time Frame: Measured at 24 weeks after 48 weeks treatment (72 weeks) ]Serum HCV-RNA was qualitatively measured by reverse transcriptase polymerase chain reaction (RT-PCR)
Secondary Outcome Measures:
- Number of Participants With Undetectable HCV-RNA at Week 24 [ Time Frame: Week 24 ]Serum HCV-RNA was qualitatively measured by reverse transcriptase polymerase chain reaction (RT-PCR)
- Number of Participants With Undetectable HCV-RNA at End of Treatment [ Time Frame: Up to 48 weeks ]Serum HCV-RNA was qualitatively measured by reverse transcriptase polymerase chain reaction (RT-PCR)
|Study Start Date:||June 2007|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
|Experimental: Peginterferon alfa-2b + Ribavirin||
Biological: Peginterferon alfa-2b
Administered at 1.0 µg/kg/week SC for 48 weeks
Other Name: SCH 054031Drug: 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
Other Name: SCH 018908
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