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

Completed

• Conditions: Hepatitis C, Chronic; Hepatitis C
• Interventions: Drug: peginterferon alfa-2b; Drug: ribavirin

• Registration Number: NCT00724295
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-29
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-03
• Last Update Posted: 2015-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1077

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm 1	ribavirin	Overall study population
Arm 1	peginterferon alfa-2b	Overall study population

Primary Outcome Measures

Name	Time	Method
Assessment of trends of adverse drug reactions by patient factors and concomitant medications. Incidence of adverse events (AEs) in the elderly vs younger patients; rates of hematologic AEs; dose reduction and discontinuation rates.	From the time the informed consent is signed and up to 30 days after study completion or discontinuation. Treatment period is 48 weeks with a 24 week post dose followup.
Sustained virologic response rate and improvement of ALT (alanine transaminase).	Assessed at the end-of-treatment and at 24 weeks post-treatment.
Overall incidence of adverse events and adverse drug reactions.	From the time the informed consent is signed and up to 30 days after study completion or discontinuation. Treatment period is 48 weeks with a 24 week post dose followup.