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

Study Overview
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Brief Summary
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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.

Official Title
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PEG Intron/REBETOL Combination Therapy Special Investigation -Investigation on the Safety and Efficacy of PegIntron and REBETOL Combination Therapy in Patients With Chronic Hepatitis C-

Conditions
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Hepatitis C, Chronic, Hepatitis C

Intervention / Treatment
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* Drug: peginterferon alfa-2b
* Drug: ribavirin


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm 1<br>Overall study population | Drug: peginterferon alfa-2b<br>* PegIntron powder (reconstituted) administered in accordance with approved labeling; Subcutaneous injection of 1.5 ug/kg once weekly for 48 weeks.<br>* Other names: SCH 54031;Drug: ribavirin<br>* Rebetol capsule administered orally twice daily in accordance with approved labeling (weight based dosing). Dosing duration 48 weeks.<br>* Other names: SCH 18908;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. |