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

NCT ID: NCT00039871

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2333 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-31
• Study Completion Date: 2007-09-30

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).

Conditions

Hepatitis; Hepatitis C, Chronic; Fibrosis; Liver Cirrhosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Overall study population

Group Type: EXPERIMENTAL

PegIntron (peginterferon alfa-2b; SCH 54031)

Intervention Type: BIOLOGICAL

PegIntron (peginterferon alfa-2b) administered at a dose of 1.5 mcg/kg subcutaneously (SC) once a week (QW) for up to 48 weeks

REBETOL (ribavirin; SCH 18908)

Intervention Type: DRUG

REBETOL (ribavirin) administered on a weight basis: 800-1400 mg/day orally (PO) for up to 48 weeks

Interventions

PegIntron (peginterferon alfa-2b; SCH 54031)

PegIntron (peginterferon alfa-2b) administered at a dose of 1.5 mcg/kg subcutaneously (SC) once a week (QW) for up to 48 weeks

Intervention Type: BIOLOGICAL

REBETOL (ribavirin; SCH 18908)

REBETOL (ribavirin) administered on a weight basis: 800-1400 mg/day orally (PO) for up to 48 weeks

Intervention Type: DRUG

Other Intervention Names

SCH 54031

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Poynard T, Munteanu M, Colombo M, Bruix J, Schiff E, Terg R, Flamm S, Moreno-Otero R, Carrilho F, Schmidt W, Berg T, McGarrity T, Heathcote EJ, Goncales F, Diago M, Craxi A, Silva M, Boparai N, Griffel L, Burroughs M, Brass C, Albrecht J. FibroTest is an independent predictor of virologic response in chronic hepatitis C patients retreated with pegylated interferon alfa-2b and ribavirin in the EPIC(3) program. J Hepatol. 2011 Feb;54(2):227-35. doi: 10.1016/j.jhep.2010.06.038. Epub 2010 Sep 15.

Reference Type: RESULT

PMID: 21056496 (View on PubMed)

Other Identifiers

P02370

Identifier Type: -

Identifier Source: org_study_id