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)

February 2, 2015 updated by: Merck Sharp & Dohme LLC

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"-

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

505

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • SCH 54031
Drug: Rebetol (ribavirin; SCH 18908)
Rebetol administered orally twice daily in accordance with approved labeling. Dosing duration 24 weeks.
Other Names:
  • SCH 18908

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Assessed from the time the informed consent is signed up until 30 days after completion or discontinuation from the study
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
Assessed from the time the informed consent is signed up until 30 days after completion or discontinuation from the study
Sustained virologic response rate by HCV genotype, baseline viral load, and patient demographic characteristics
Time Frame: Assessed at 24 weeks post-treatment
Assessed at 24 weeks post-treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
End of treatment and 24 weeks after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

July 25, 2008

First Submitted That Met QC Criteria

July 25, 2008

First Posted (Estimate)

July 29, 2008

Study Record Updates

Last Update Posted (Estimate)

February 3, 2015

Last Update Submitted That Met QC Criteria

February 2, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P04841

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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