MedTrace Logo

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)

NCT00724230 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 505

Last updated 2015-02-03

No results posted yet for this study

Summary

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.

Conditions

  • Hepatitis C, Chronic
  • Hepatitis C

Interventions

DRUG

PegIntron (peginterferon alfa-2b; SCH 54031)

PegIntron administered in accordance with approved labeling Subcutaneous injection once weekly for 24 weeks.

DRUG

Rebetol (ribavirin; SCH 18908)

Rebetol administered orally twice daily in accordance with approved labeling. Dosing duration 24 weeks.

Sponsors & Collaborators

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2008-12-31
Completion
2008-12-31

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00724230 on ClinicalTrials.gov