Trials / Completed
CompletedNCT00723892
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 614 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Peginterferon alfa-2b (PegIntron) | 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 |
| DRUG | Rebetol (Ribavirin) | Rebetol was administered orally based on the prescribed dose. The average dose for Rebetol was 950 ± 167.2 mg\^day |
| BEHAVIORAL | Psychotherapy support program | Each site has implemented a psychotherapy support program. |
Timeline
- Start date
- 2005-07-01
- Primary completion
- 2009-05-01
- Completion
- 2009-05-01
- First posted
- 2008-07-29
- Last updated
- 2015-10-30
- Results posted
- 2010-09-20
Source: ClinicalTrials.gov record NCT00723892. Inclusion in this directory is not an endorsement.