Adherence in Patients Receiving PegIntron/Rebetol for Hepatitis C in Conjunction With a Psychotherapy Support Program (Study P04252)

Completed

• Conditions: Hepatitis C, Chronic; Hepacivirus
• Interventions: Biological: Peginterferon alfa-2b (PegIntron); Drug: Rebetol (Ribavirin); Behavioral: Psychotherapy support program

• Registration Number: NCT00723892
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Several psychiatric adverse events (eg, depression, fatigue, psychoses, behavior troubles, anxiety, irritability, deteriorated concentration, and insomnia) that are likely to occur during the treatment course with PegIntron plus Rebetol may prompt patients to discontinue their treatment early. The goal of this study is to assess whether a psychotherapy support program may contribute to a better adherence rate.

Detailed Description

Enrollment of participants will occur in a sequential order of treatment initiation.

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-29
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Results First Submitted: 2010-08-25
• Results First Submitted QC: 2010-08-25
• Results First Posted: 2010-09-20
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-29
• Last Update Posted: 2015-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 614

Inclusion Criteria

• Adult patients with hepatitis C

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Exclusion Criteria

• According to the products' labeling

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PegIntron/Rebetol and psychotherapy support program	Peginterferon alfa-2b (PegIntron)	Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
PegIntron/Rebetol alone (no psychotherapy)	Rebetol (Ribavirin)	Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
PegIntron/Rebetol and psychotherapy support program	Psychotherapy support program	Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
PegIntron/Rebetol alone (no psychotherapy)	Peginterferon alfa-2b (PegIntron)	Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
PegIntron/Rebetol and psychotherapy support program	Rebetol (Ribavirin)	Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C When Administered With a Patient Psychotherapy Support Program as Compared to a Group Without a Psychotherapy Support Program.	12 months after onset of treatment

Secondary Outcome Measures

Name	Time	Method
the Average Length of Treatment for Participants on Treatment for Hepatitis C With PegIntron Pen/Rebetol	12 months after onset of treatment