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

Last updated: March 7, 2017
Sponsor: Merck Sharp & Dohme Corp.
Overall Status: Completed

Phase

3

Condition

Hepatic Fibrosis

Liver Disorders

Hepatitis

Treatment

N/A

Clinical Study ID

NCT00039871
P02370
  • Ages 18-65
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age at entry 18-65

  • Positive for Hepatitis C

  • Nonresponder to previous treatment (minimum of 3 months) with an alpha Interferon plusribavirin

  • Liver biopsy demonstrating moderate to severe fibrosis or cirrhosis

Exclusion

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 andcompletion of the study

Study Design

Total Participants: 2333
Study Start date:
May 01, 2002
Estimated Completion Date:
September 30, 2007