N/A
Completed N=568
Adherence in Patients Receiving PegIntron/Rebetol for Hepatitis C in Conjunction With a Psychotherapy Support Program (Study P04252)
Hepatitis C, Chronic · Hepacivirus
Source: ClinicalTrials.gov NCT00723892 ↗
Enrolled (actual)
568
Serious AEs
1.8%
Results posted
Sep 2010
Primary outcomePrimary: 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. — 206; 168 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
206; 168 | — |
| SECONDARY the Average Length of Treatment for Participants on Treatment for Hepatitis C With PegIntron Pen/Rebetol |
36.1; 35.3 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients with hepatitis C
Exclusion Criteria
- According to the products' labeling
Data sourced from ClinicalTrials.gov (NCT00723892). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.