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

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Hepatitis C, Chronic; Hepacivirus

Treatments: Behavioral: Psychotherapy support program; Drug: Rebetol (Ribavirin); Biological: Peginterferon alfa-2b (PegIntron)

Study type: Observational

Funder types: Industry

Identifiers

NCT00723892

MK-4031-245 (Other Identifier)

P04252

Details and patient eligibility

About

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.

Full description

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

Enrollment: 614 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients with hepatitis C

Exclusion criteria

• According to the products' labeling

Trial design

614 participants in 2 patient groups

PegIntron/Rebetol and psychotherapy support program

Description:

Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.

Treatment:

Behavioral: Psychotherapy support program

Drug: Rebetol (Ribavirin)

Biological: Peginterferon alfa-2b (PegIntron)

PegIntron/Rebetol alone (no psychotherapy)

Description:

Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.

Treatment:

Drug: Rebetol (Ribavirin)

Biological: Peginterferon alfa-2b (PegIntron)