Adherence in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program (Study P04281)(COMPLETED)

Completed

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

• Registration Number: NCT00704522
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Patients receiving a patient assistance program during therapy for Hepatitis C will be enrolled into this study. All patients will receive PegIntron pen and Rebetol according to label and the patient assistance program. This study will be compared to similar studies from other clinics using various patient support programs for the purpose of designing future comparative phase IV studies.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2008-06-23
• Study First Submitted QC: 2008-06-23
• Study First Posted: 2008-06-25
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Results First Submitted: 2010-04-21
• Results First Submitted QC: 2010-04-21
• Results First Posted: 2010-05-17
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-05
• Last Update Posted: 2015-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 601

Inclusion Criteria

• Adult patients with hepatitis C

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Exclusion Criteria

• According to the products' labeling (refer to Warnings, contraindications, and safety sections).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with hepatitis C	Ribavirin (SCH 18908)	Patients receiving a patient assistance program during therapy for hepatitis C at sites in Austria.
Patients with hepatitis C	Patient assistance program	Patients receiving a patient assistance program during therapy for hepatitis C at sites in Austria.
Patients with hepatitis C	Peginterferon alfa-2b (SCH 54031)	Patients receiving a patient assistance program during therapy for hepatitis C at sites in Austria.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Complete Treatment With PegIntron Pen/Rebetol Therapy for Hepatitis C When Administered With a Patient Assistance Program	24 or 48 weeks (depending on genotype) and 24 weeks of follow up
Average Length of Treatment With PegIntron/Rebetol	After start of treatment