PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to Alpha-Interferon Plus Ribavirin (Study P02370)

Phase 3

Completed

• Conditions: Hepatitis C, Chronic; Fibrosis; Hepatitis; Liver Cirrhosis
• Interventions: Biological: PegIntron (peginterferon alfa-2b; SCH 54031); Drug: REBETOL (ribavirin; SCH 18908)

• Registration Number: NCT00039871
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The objective of this study is to determine the effectiveness of PEG-Intron 1.5 ug/kg/wk plus REBETOL (ribavirin) 800-1400 mg/day in adults with chronic hepatitis C with moderate to severe liver fibrosis or cirrhosis who failed to respond to previous treatment with an alpha interferon in combination with ribavirin. Patients who do not respond to PEG-Intron plus REBETOL (ribavirin) will be enrolled in a long-term maintenance study to evaluate the effectiveness of PEG-Intron monotherapy versus no treatment for the prevention of disease progression (Protocols P02569 and P02570).

Detailed Description

Not available

Study Timeline

• Study Start: 2002-05
• Study First Submitted: 2002-06-13
• Study First Submitted QC: 2002-06-13
• Study First Posted: 2002-06-14
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Results First Submitted: 2008-09-29
• Results First Submitted QC: 2008-12-10
• Results First Posted: 2008-12-11
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-07
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2333

Inclusion Criteria

• Age at entry 18-65
• Positive for Hepatitis C
• Nonresponder to previous treatment (minimum of 3 months) with an alpha Interferon plus ribavirin
• Liver biopsy demonstrating moderate to severe fibrosis or cirrhosis

Exclusion Criteria

• Any cause for the liver disease other than chronic hepatitis C
• History or presence of complications of cirrhosis
• Alcohol or illicit drug use or methadone treatment within the past 2 years
• Treatment for chronic hepatitis C within the previous 6 months
• Diseases or conditions that could interfere with the subject's participation in and completion of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Overall study population	REBETOL (ribavirin; SCH 18908)	-
Overall study population	PegIntron (peginterferon alfa-2b; SCH 54031)	-

Primary Outcome Measures

Name	Time	Method
Sustained Virologic Response (SVR) Rate	Assessed at end of 24 weeks posttreatment follow-up	Number of participants with undetectable hepatitis C virus RNA (HCV-RNA)

Secondary Outcome Measures

Name	Time	Method
Sustained Virologic Response (SVR) for Participants With Undetectable HCV-RNA at Treatment Week 12	24 weeks posttreatment	Number of participants with undetectable HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up
Sustained Virologic Response (SVR) for Participants With Detectable But ≥2 Log Drop in HCV-RNA at Treatment Week 12	24 weeks posttreatment	Number of participants with detectable HCV-RNA but ≥2 log drop from baseline in HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up