Treatment of Patients With Chronic Hepatitis C With PegIntron as Monotherapy or in Combination With Ribavirin (Study P04437)(COMPLETED)

Completed

• Conditions: Hepatitis C, Chronic; Hepacivirus
• Interventions: Biological: Peginterferon alfa-2b (SCH 54031); Drug: Ribavirin (SCH 18908)

• Registration Number: NCT00705666
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

In February 2002, a French Consensus Conference on the management of patients with chronic hepatitis C in France was organized. The jury issued several recommendations on pegylated alpha interferon/ribavirin treatment strategy. Three years after these recommendations, it is of interest to understand the evolution of hepatitis C management in France in real clinical practice. This observational study will permit the identification of patients who are treated and will provide information on the use of PegIntron/ Ribavirin.

Detailed Description

To assure a good representation of participants treated for hepatitis C, participants who meet the inclusion criteria will be enrolled on a consecutive basis.

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2008-06-23
• Study First Submitted QC: 2008-06-25
• Study First Posted: 2008-06-26
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Results First Submitted: 2010-03-30
• Results First Submitted QC: 2010-05-27
• Results First Posted: 2010-06-24
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-01
• Last Update Posted: 2015-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 789

Inclusion Criteria

• Adult participants starting a treatment with PegIntron for the treatment of chronic hepatitis C.

Read More

Exclusion Criteria

• Concomitant participation in a clinical trial for the treatment of hepatitis C.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PegIntron as monotherapy or in combination with Ribavirin.	Ribavirin (SCH 18908)	Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin.
PegIntron as monotherapy or in combination with Ribavirin.	Peginterferon alfa-2b (SCH 54031)	Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin.

Primary Outcome Measures

Name	Time	Method
The Number of Participants Receiving the Recommended Treatment Duration (24 Weeks for Genotypes 2 and 3 and 48 Weeks for Genotype 1 According to the French 2002 Consensus Meeting).	Physicians will complete a questionnaire at these visits: treatment initiation; 12 and 24 weeks after treatment initiation and 24 weeks after the end of treatment; and 36 and 48 weeks after treatment initiation for participants treated for 48 weeks.