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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00724295
First received: July 25, 2008
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Hepatitis C, Chronic
Hepatitis C
Drug: peginterferon alfa-2b
Drug: ribavirin

Study Type: Observational
Study Design: Time Perspective: Prospective
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-

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • Sustained virologic response rate and improvement of ALT (alanine transaminase). [ Time Frame: Assessed at the end-of-treatment and at 24 weeks post-treatment. ] [ Designated as safety issue: No ]

Enrollment: 1077
Study Start Date: April 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Arm 1
Overall study population
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.
Other Names:
  • PegIntron
  • SCH 54031
Drug: ribavirin
Rebetol capsule administered orally twice daily in accordance with approved labeling (weight based dosing). Dosing duration 48 weeks.
Other Names:
  • Rebetol
  • SCH 18908

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with chronic hepatitis C treated with PegIntron and Rebetol combination therapy in the clinical practice at approximately 100 to 200 institutions in Japan.

Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00724295     History of Changes
Other Study ID Numbers: P04505
Study First Received: July 25, 2008
Last Updated: February 27, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2b
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014