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

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.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peginterferon alfa-2b

Drug

PegIntron powder (reconstituted) administered in accordance with approved labeling; Subcutaneous injection of 1.5 ug/kg once weekly for 48 weeks.

Other names: PegIntron, SCH 54031

Ribavirin

Drug

Rebetol capsule administered orally twice daily in accordance with approved labeling (weight based dosing). Dosing duration 48 weeks.

Other names: Rebetol, SCH 18908

Primary outcomes

Overall incidence of adverse events and adverse drug reactions.

Time frame: 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.

Time frame: 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).

Time frame: Assessed at the end-of-treatment and at 24 weeks post-treatment.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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-

Important dates

Study start: 2005
Primary completion: 2008
Study completion: 2008
First posted: Jul 29, 2008
Registry last updated: Feb 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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