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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Hepatitis C, Chronic

Hepatitis

Liver Cirrhosis

Fibrosis

Treatments

Biological: PegIntron (peginterferon alfa-2b; SCH 54031)

Drug: REBETOL (ribavirin; SCH 18908)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00039871

P02370

Details and patient eligibility

About

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).

Enrollment

2,333 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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