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

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Interferon-alpha; Peginterferon alfa-2b; Ribavirin

Criteria

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