Adherence in Patients Receiving PegIntron/Rebetol for Hepatitis C in Conjunction With a Psychotherapy Support Program (Study P04252)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00723892
First received: July 25, 2008
Last updated: June 23, 2014
Last verified: June 2014

July 25, 2008
June 23, 2014
July 2005
May 2009   (final data collection date for primary outcome measure)
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 ]
To evaluate the proportion of patients who complete treatment with PegIntron pen/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: D0, M1, M3, M6, for genotype 2 and 3; 2 other visits at M9 and M12 for genotype 1. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00723892 on ClinicalTrials.gov Archive Site
the Average Length of Treatment for Participants on Treatment for Hepatitis C With PegIntron Pen/Rebetol [ Time Frame: 12 months after onset of treatment ] [ Designated as safety issue: No ]
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: D0, M1, M3, M6, for genotype 2 and 3; 2 other visits at M9 and M12 for genotype 1. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

Enrollment of participants will occur in a sequential order of treatment initiation.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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.

  • Hepatitis C, Chronic
  • Hepacivirus
  • 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:
    • PegIntron pen
    • SCH 54031
    • ViraferonPeg
  • 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:
    • Ribavirin
    • SCH 18908
  • Behavioral: Psychotherapy support program
    Each site has implemented a psychotherapy support program.
  • PegIntron/Rebetol and psychotherapy support program
    Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
    Interventions:
    • Biological: Peginterferon alfa-2b (PegIntron)
    • Drug: Rebetol (Ribavirin)
    • Behavioral: Psychotherapy support program
  • PegIntron/Rebetol alone (no psychotherapy)
    Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
    Interventions:
    • Biological: Peginterferon alfa-2b (PegIntron)
    • Drug: Rebetol (Ribavirin)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
614
May 2009
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients with hepatitis C

Exclusion Criteria:

  • According to the products' labeling
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00723892
P04252, MK-4031-245
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP