CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 746 enrolled
Drug / intervention
PegIntron +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00704964
NCT00704964N/ACompleted

Impact of Patient Support From Medical Staff on the Adherence to Therapy With PegIntron Plus Rebetol

Merck Sharp & Dohme LLC·observational·Posted Jun 25, 2008·Updated Oct 6, 2015

In Brief

An observational study evaluating PegIntron and Rebetol for Hepatitis C and Chronic Hepatitis C. Completed, enrolled 746 participants.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 25, 2008
Enrollment StartMay 1, 2005
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 18.0 years ago

Interventions

PegIntronbiological

PegIntron (peginterferon alfa-2b) pen administered at a dose and frequency in accordance with approved labeling in Germany

Rebetoldrug

Rebetol (ribavirin) administered at a dose and frequency in accordance with approved labeling in Germany