Compliance of HCV Genotype 1 Infected Patients Receiving PegIntron/Rebetol and a Patient Assistance Program (Study P04671)

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Hepatitis C, Chronic; Hepatitis C

Treatments: Behavioral: Patient Assistance Program; Biological: PegIntron (peginterferon alfa-2b; SCH 54031); Drug: Rebetol (ribavirin; SCH 18908)

Study type: Observational

Funder types: Industry

Identifiers

NCT00728494

P04671

Details and patient eligibility

About

Enrolled patients will be recruited to two parallel groups during therapy for Hepatitis C. Patients in the first one will receive a patient assistance program, and patients in the second group will not. All patients will receive PegIntron and Rebetol according to label.

Full description

Non-Probability Sample, Commercial product used according to EU label.

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• According to PegIntron/Rebetol label.
• Only HCV genotype 1 infected patients will be enrolled in the study.

Exclusion criteria

• According to PegIntron/Rebetol label.

Trial design

99 participants in 2 patient groups

Treatment and Patient Assistance Program

Description:

Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.

Treatment:

Behavioral: Patient Assistance Program

Drug: Rebetol (ribavirin; SCH 18908)

Biological: PegIntron (peginterferon alfa-2b; SCH 54031)

Treatment Alone

Description:

PegIntron/Rebetol treatment only.

Treatment:

Drug: Rebetol (ribavirin; SCH 18908)

Biological: PegIntron (peginterferon alfa-2b; SCH 54031)