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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00723892
First Posted: July 29, 2008
Last Update Posted: October 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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: Observatory on Treatment Adhesion in Patients Suffering From Hepatitis C Chronic Treated With ViraferonPeg® Injected / Rebetol® in Conjunction With a Psychotherapeutic Assistance Program

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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 ]

Secondary Outcome Measures:
  • the Average Length of Treatment for Participants on Treatment for Hepatitis C With PegIntron Pen/Rebetol [ Time Frame: 12 months after onset of treatment ]

Enrollment: 614
Study Start Date: July 2005
Study Completion Date: May 2009
Primary Completion Date: May 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:
  • 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 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:
  • 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

Detailed Description:
Enrollment of participants will occur in a sequential order of treatment initiation.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00723892


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00723892     History of Changes
Other Study ID Numbers: P04252
MK-4031-245 ( Other Identifier: Merck )
First Submitted: July 25, 2008
First Posted: July 29, 2008
Results First Submitted: August 25, 2010
Results First Posted: September 20, 2010
Last Update Posted: October 30, 2015
Last Verified: October 2015

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
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs