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
  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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723892

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00723892     History of Changes
Other Study ID Numbers: P04252, MK-4031-245
Study First Received: July 25, 2008
Results First Received: August 25, 2010
Last Updated: June 23, 2014
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
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014