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

Hepatitis C, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723892
• Other study ID #: P04252
• Secondary ID: MK-4031-245
• Status: Completed
• Phase: N/A
• First received: July 25, 2008
• Last updated: October 29, 2015
• Start date: July 2005
• Est. completion date: May 2009

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 614
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients with hepatitis C

Exclusion Criteria:

• According to the products' labeling

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepacivirus
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

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

Drug:
• Rebetol (Ribavirin)
Rebetol was administered orally based on the prescribed dose. The average dose for Rebetol was 950 ± 167.2 mg^day

Behavioral:
• Psychotherapy support program
Each site has implemented a psychotherapy support program.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		12 months after onset of treatment	No
Secondary	the Average Length of Treatment for Participants on Treatment for Hepatitis C With PegIntron Pen/Rebetol		12 months after onset of treatment	No