Adherence in Patients Receiving PegIntron/Rebetol for Hepatitis C in Conjunction With a Psychotherapy Support Program (Study P04252)
Observatory on Treatment Adhesion in Patients Suffering From Hepatitis C Chronic Treated With ViraferonPeg® Injected / Rebetol® in Conjunction With a Psychotherapeutic Assistance Program
2 other identifiers
observational
614
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2005
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 25, 2008
CompletedFirst Posted
Study publicly available on registry
July 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedResults Posted
Study results publicly available
September 20, 2010
CompletedOctober 30, 2015
October 1, 2015
3.8 years
July 25, 2008
August 25, 2010
October 29, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
the Average Length of Treatment for Participants on Treatment for Hepatitis C With PegIntron Pen/Rebetol
12 months after onset of treatment
Study Arms (2)
PegIntron/Rebetol and psychotherapy support program
Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
PegIntron/Rebetol alone (no psychotherapy)
Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
Interventions
Peginterferon alfa-2b (PegIntron) was administered based on the prescribed dose. The average dose for PegIntron was a weekly injection of 1.5 ± 0.3 μg\^kg\^week
Rebetol was administered orally based on the prescribed dose. The average dose for Rebetol was 950 ± 167.2 mg\^day
Each site has implemented a psychotherapy support program.
Eligibility Criteria
Participants at sites in France who are receiving a psychotherapy support program during therapy for hepatitis C and a control group without a psychotherapy support program.
You may qualify if:
- Adult patients with hepatitis C
You may not qualify if:
- According to the products' labeling
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2008
First Posted
July 29, 2008
Study Start
July 1, 2005
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
October 30, 2015
Results First Posted
September 20, 2010
Record last verified: 2015-10