Adherence in Patients Receiving PegIntron/Rebetol for Hepatitis C in Conjunction With a Psychotherapy Support Program (Study P04252)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis C, Chronic; Hepacivirus
Intervention: Peginterferon alfa-2b (PegIntron) (Biological); Rebetol (Ribavirin) (Drug); Psychotherapy support program (Behavioral)
Phase: N/A
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Merck Sharp & Dohme Corp.
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.
Clinical Details
Official title: Observatory on Treatment Adhesion in Patients Suffering From Hepatitis C Chronic Treated With ViraferonPeg® Injected / Rebetol® in Conjunction With a Psychotherapeutic Assistance Program
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: 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.
Secondary outcome: the Average Length of Treatment for Participants on Treatment for Hepatitis C With PegIntron Pen/Rebetol
Detailed description:
Enrollment of participants will occur in a sequential order of treatment initiation.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adult patients with hepatitis C
Exclusion Criteria:
- According to the products' labeling
Locations and Contacts
Additional Information
Starting date: July 2005
Last updated: June 8, 2015
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