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

Hepatitis C Clinical Trial

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-

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00724295
• Other study ID #: P04505
• Status: Completed
• Phase: N/A
• First received: July 25, 2008
• Last updated: February 3, 2015
• Start date: April 2005
• Est. completion date: December 2008

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1077
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• peginterferon alfa-2b
PegIntron powder (reconstituted) administered in accordance with approved labeling; Subcutaneous injection of 1.5 ug/kg once weekly for 48 weeks.
• ribavirin
Rebetol capsule administered orally twice daily in accordance with approved labeling (weight based dosing). Dosing duration 48 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Primary	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.	Yes
Primary	Sustained virologic response rate and improvement of ALT (alanine transaminase).		Assessed at the end-of-treatment and at 24 weeks post-treatment.	No