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

October 29, 2015 updated by: Merck Sharp & Dohme LLC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

614

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • Adult patients with hepatitis C

Exclusion Criteria:

  • According to the products' labeling

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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:
  • SCH 54031
  • PegIntron pen
  • 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:
  • SCH 18908
  • Ribavirin
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:
  • SCH 54031
  • PegIntron pen
  • 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:
  • SCH 18908
  • Ribavirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months after onset of treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (ACTUAL)

May 1, 2009

Study Completion (ACTUAL)

May 1, 2009

Study Registration Dates

First Submitted

July 25, 2008

First Submitted That Met QC Criteria

July 25, 2008

First Posted (ESTIMATE)

July 29, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 30, 2015

Last Update Submitted That Met QC Criteria

October 29, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P04252
  • MK-4031-245 (OTHER: Merck)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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