Adherence in Patients Receiving PegIntron/Rebetol for Hepatitis C in Conjunction With a Psychotherapy Support Program (Study P04252)(COMPLETED)
This study has been completed.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00723892
First received: July 25, 2008
Last updated: February 25, 2011
Last verified: February 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hepatitis C, Chronic Hepacivirus |
Biological: Peginterferon alfa-2b (PegIntron) Drug: Rebetol (Ribavirin) Behavioral: Psychotherapy support program |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Evaluation of Adherence Rate in Patients Receiving PegIntron Pen / Rebetol for Hepatitis C in Conjunction With a Psychotherapy Support Program. |
Resource links provided by NLM:
Further study details as provided by Schering-Plough:
Primary Outcome Measures:
- 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. [ Time Frame: 12 months after onset of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To Evaluate the Average Length of Treatment for Patients Receiving Psychotherapy Support During the Course of Their Treatment for Hepatitis C With PegIntron Pen/Rebetol [ Time Frame: (Day 0) D0, (Month 1) M1, (Month 3) M3, (Month 6) M6, for genotype 2 and 3; 2 other visits at (Month 9) M9 and (Month 12) M12 for genotype 1 ] [ Designated as safety issue: No ]
| Enrollment: | 614 |
| Study Start Date: | July 2005 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
PegIntron/Rebetol and psychotherapy support program
Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
|
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
Other Names:
Drug: Rebetol (Ribavirin)
Rebetol was administered orally based on the prescribed dose. The average dose for Rebetol was 950 ± 167.2 mg^day
Other Names:
Behavioral: Psychotherapy support program
Each site has implemented a psychotherapy support program.
|
|
PegIntron/Rebetol alone (no psychotherapy)
Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
|
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
Other Names:
Drug: Rebetol (Ribavirin)
Rebetol was administered orally based on the prescribed dose. The average dose for Rebetol was 950 ± 167.2 mg^day
Other Names:
|
Detailed Description:
Enrollment of participants will occur in a sequential order of treatment initiation.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
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.
Criteria
Inclusion Criteria:
- Adult patients with hepatitis C
Exclusion Criteria:
- According to the products' labeling
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00723892 History of Changes |
| Other Study ID Numbers: | P04252 |
| Study First Received: | July 25, 2008 |
| Results First Received: | August 25, 2010 |
| Last Updated: | February 25, 2011 |
| Health Authority: | France: Ministry of Health |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |
Hepatitis, Chronic Ribavirin Peginterferon alfa-2b Interferon-alpha Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013