Safety and Efficacy of PegIntron Plus Rebetol in Patients With Chronic Hepatitis C in Japan, Excluding (1) Subjects With HCV Genotype 1 and High Viral Load, and (2) Interferon-naïve Subjects With Low Viral Load (Study P04841)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00724230
First received: July 25, 2008
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

The objective of the study is to evaluate the safety and efficacy of PegIntron plus Rebetol combination therapy administered to patients with chronic hepatitis C. The study will exclude (1) subjects with HCV genotype 1 and high viral load, and (2) interferon-naïve subjects with low viral load. It is being conducted as a post-approval commitment, in accordance with the Ministry of Health, Labour and Welfare's guideline on Good Post-marketing Study Practice.

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: PegIntron (peginterferon alfa-2b; SCH 54031)
Drug: Rebetol (ribavirin; SCH 18908)

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: PegIntron/REBETOL Combination Therapy Designated Drug Use Investigation -Investigation on the Safety and Efficacy of PegIntron and REBETOL Combination Therapy in Patients With Chronic Hepatitis C Excluding Those With "IFN Naive Low Viral Load and Genotype 1 and High Viral Load"-

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: Assessed from the time the informed consent is signed up until 30 days after completion or discontinuation from the study ] [ Designated as safety issue: Yes ]
  • Assessment of trends of adverse drug reactions by patient factors and concomitant medications; Incidence, severity, and outcome of adverse events (AEs) between the elderly vs younger patients [ Time Frame: Assessed from the time the informed consent is signed up until 30 days after completion or discontinuation from the study ] [ Designated as safety issue: Yes ]
  • Sustained virologic response rate by HCV genotype, baseline viral load, and patient demographic characteristics [ Time Frame: Assessed at 24 weeks post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of ALT normalization at end of treatment period and at 24 weeks post completing therapy. [ Time Frame: End of treatment and 24 weeks after end of treatment ] [ Designated as safety issue: No ]

Enrollment: 505
Study Start Date: February 2006
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: PegIntron (peginterferon alfa-2b; SCH 54031)

PegIntron administered in accordance with approved labeling

Subcutaneous injection once weekly for 24 weeks.

Other Name: SCH 54031
Drug: Rebetol (ribavirin; SCH 18908)
Rebetol administered orally twice daily in accordance with approved labeling. Dosing duration 24 weeks.
Other Name: SCH 18908

  Eligibility

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

Patients with chronic hepatitis C excluding subjects with HCV genotype 1 and high viral load, and interferon-naïve subjects with low viral load. Patients undergoing treatment with PegIntron and Rebetol in clinical practice at approximately 50 to 100 sites in Japan.

Criteria

Inclusion Criteria:

  • Patients diagnosed with chronic hepatitis C
  • Among interferon-naïve patients, only patients with high viral load and HCV genotype other than 1
  • Among prior nonresponders or relapsers to interferon monotherapy, (1) patients with high viral load and HCV genotype other than 1; and (2) patients with low viral load of all genotypes (including genotype 1)

Exclusion Criteria:

  • Patients infected with HCV genotype 1 with high viral load, regardless of whether treatment-naïve or previous nonresponders/relapsers
  • Interferon-naïve patients with low viral load
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00724230     History of Changes
Other Study ID Numbers: P04841
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 C
Hepatitis C, Chronic
Hepatitis
Hepatitis A
Hepatitis, 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
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014