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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C, Chronic; Hepatitis C

Intervention: peginterferon alfa-2b (Drug); ribavirin (Drug)

Phase: N/A

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.


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.

Clinical Details

Official 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-

Study design: Time Perspective: Prospective

Primary outcome:

Overall incidence of adverse events and adverse drug reactions.

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.

Sustained virologic response rate and improvement of ALT (alanine transaminase).


Minimum age: N/A. Maximum age: N/A. Gender(s): Both.


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


- 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

Locations and Contacts

Additional Information

Starting date: April 2005
Last updated: February 3, 2015

Page last updated: August 23, 2015

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