Impact of Patient Support by the Medical Staff on Adherence to Therapy With PegIntron Plus Rebetol (Study P04413) (@dhere)

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Hepatitis C; Chronic Hepatitis C

Treatments: Drug: Rebetol; Biological: PegIntron

Study type: Observational

Funder types: Industry

Identifiers

NCT00704964

P04413

Details and patient eligibility

About

The objective of this study is to assess the impact of participant care and support on treatment adherence. PegIntron pen and Rebetol will be administered to participants with Hepatitis C Virus (HCV) in accordance with approved labeling. Sites will be categorized as providing high vs low level of participant management based on information about the level of participant support and management captured on the site questionnaire. Data on each participant will be collected by a physician on an electronic participant case report form (CRF) and by the participant via a questionnaire. Treatment completion rates will be analyzed based on the high vs low level of participant management.

The hypothesis is that Physicians investing more time and effort into participant management achieve higher treatment completion rates among their hepatitis C patients than physicians offering less participant management measures.

Enrollment: 746 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with chronic hepatitis C.

Those participating in patient assistance programs during therapy for hepatitis C.

Exclusion criteria

• Participants who have previously been treatment for hepatitis C (non-naïve)

Other exclusion criteria as described in local Summary of Product Characteristics (SPC).

Trial design

746 participants in 1 patient group

All participants

Description:

Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.

Treatment:

Drug: Rebetol

Biological: PegIntron