Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-26 @ 9:37 AM
Study NCT ID:
NCT00723892
Status:
COMPLETED
Last Update Posted:
2015-10-30
First Post:
2008-07-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Adherence in Patients Receiving PegIntron/Rebetol for Hepatitis C in Conjunction With a Psychotherapy Support Program (Study P04252)
Sponsor:
Merck Sharp & Dohme LLC
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| MK-4031-245 | OTHER | Merck | View |