Observatory on Treatment Adhesion in Patients Suffering From Hepatitis C Chronic Treated With ViraferonPeg® Injected / Rebetol® in Conjunction With a Psychotherapeutic Assistance Program
Overview
- Phase
- Not Applicable
- Intervention
- Peginterferon alfa-2b (PegIntron)
- Conditions
- Hepatitis C, Chronic
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 614
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult patients with hepatitis C
Exclusion Criteria
- •According to the products' labeling
Arms & Interventions
PegIntron/Rebetol and psychotherapy support program
Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
Intervention: Peginterferon alfa-2b (PegIntron)
PegIntron/Rebetol and psychotherapy support program
Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
Intervention: Rebetol (Ribavirin)
PegIntron/Rebetol and psychotherapy support program
Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
Intervention: Psychotherapy support program
PegIntron/Rebetol alone (no psychotherapy)
Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
Intervention: Peginterferon alfa-2b (PegIntron)
PegIntron/Rebetol alone (no psychotherapy)
Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
Intervention: Rebetol (Ribavirin)
Outcomes
Primary Outcomes
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.
Time Frame: 12 months after onset of treatment
Secondary Outcomes
- the Average Length of Treatment for Participants on Treatment for Hepatitis C With PegIntron Pen/Rebetol(12 months after onset of treatment)