Safety and Efficacy of PegIntron Plus Rebetol in Patients With Chronic Hepatitis C in Japan, Excluding (1) Subjects With HCV Genotype 1 and High Viral Load, and (2) Interferon-naïve Subjects With Low Viral Load (Study P04841)(COMPLETED)

NCT ID: NCT00724230

Last Updated: 2015-02-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 505 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2008-12-31

Brief Summary

The objective of the study is to evaluate the safety and efficacy of PegIntron plus Rebetol combination therapy administered to patients with chronic hepatitis C. The study will exclude (1) subjects with HCV genotype 1 and high viral load, and (2) interferon-naïve subjects with low viral load. It is being conducted as a post-approval commitment, in accordance with the Ministry of Health, Labour and Welfare's guideline on Good Post-marketing Study Practice.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

Conditions

Hepatitis C, Chronic; Hepatitis C

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

Arm 1

Overall study population.

PegIntron (peginterferon alfa-2b; SCH 54031)

Intervention Type: DRUG

PegIntron administered in accordance with approved labeling

Subcutaneous injection once weekly for 24 weeks.

Rebetol (ribavirin; SCH 18908)

Intervention Type: DRUG

Rebetol administered orally twice daily in accordance with approved labeling. Dosing duration 24 weeks.

Interventions

PegIntron (peginterferon alfa-2b; SCH 54031)

PegIntron administered in accordance with approved labeling

Subcutaneous injection once weekly for 24 weeks.

Intervention Type: DRUG

Rebetol (ribavirin; SCH 18908)

Rebetol administered orally twice daily in accordance with approved labeling. Dosing duration 24 weeks.

Intervention Type: DRUG

Other Intervention Names

SCH 54031; SCH 18908

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed with chronic hepatitis C
• Among interferon-naïve patients, only patients with high viral load and HCV genotype other than 1
• Among prior nonresponders or relapsers to interferon monotherapy, (1) patients with high viral load and HCV genotype other than 1; and (2) patients with low viral load of all genotypes (including genotype 1)

Exclusion Criteria

• Patients infected with HCV genotype 1 with high viral load, regardless of whether treatment-naïve or previous nonresponders/relapsers
• Interferon-naïve patients with low viral load
• Patients with a history of hypersensitivity to test drugs or other interferon preparations
• Patients with a history of hypersensitivity to biological products, such as vaccines
• Patients being treated with Shosaikoto
• Patients with autoimmune hepatitis
• Pregnant women, women who may be pregnant, and nursing mothers
• Patients with a history of hypersensitivity to any component of this drug or other nucleoside analogs (aciclovir, ganciclovir, vidarabine, etc.)
• Patients with difficult-to-control cardiac disease (eg, myocardial infarction, cardiac failure, arrhythmia)
• Patients with hemoglobinopathies (eg, thalassemia, sickle-cell anemia)
• Patients with chronic renal failure or renal function disorder with creatinine clearance of <=50 mL/min
• Patients with or a history of severe psychiatric condition such as severe depression, suicidal ideation or suicide attempt
• Patients with serious hepatic dysfunction
• Patients with autoimmune hepatitis

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P04841

Identifier Type: -

Identifier Source: org_study_id