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

NCT00724295 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1077

Last updated 2015-02-04

No results posted yet for this study

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.

Conditions

  • Hepatitis C, Chronic
  • Hepatitis C

Interventions

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.

DRUG

ribavirin

Rebetol capsule administered orally twice daily in accordance with approved labeling (weight based dosing). Dosing duration 48 weeks.

Sponsors & Collaborators

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2008-12-31
Completion
2008-12-31

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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 NCT00724295 on ClinicalTrials.gov