Safety and Efficacy of PegIntron and Rebetol Combination Therapy in Patients With Chronic Hepatitis C in Japan (Study P04505)

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Hepatitis C, Chronic; Hepatitis C

Treatments: Drug: peginterferon alfa-2b; Drug: ribavirin

Study type: Observational

Funder types: Industry

Identifiers

NCT00724295

P04505

Details and patient eligibility

About

This is a post-marketing surveillance of patients with chronic hepatitis C treated with PegIntron and Rebetol combination therapy in clinical practice in Japan. The objective of the study is to evaluate the safety and efficacy of the combination therapy. The study will also compare the safety profile of the combination therapy among elderly patients and younger patients.

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.

Enrollment: 1,077 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients with chronic hepatitis C.

• Patients are serogroup 1(genotype I (1a) or II (1b)).
• The HCV-RNA level in the blood is more than 10^5 IU/mL by RT-PCR method, or 1Meq./mL by b-DNA method

Exclusion criteria

• 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

Trial design

1,077 participants in 1 patient group

Arm 1

Description:

Overall study population

Treatment:

Drug: ribavirin

Drug: peginterferon alfa-2b