CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 197 enrolled
Drug / intervention
Educational Intervention +1 moreprocedure
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/NCT01405027
NCT01405027Phase 4Completed
CompareCT.gov

Boceprevir in Community Practice: Assessing Safety, Efficacy, Compliance and Quality of Life, Impact of an Education Program

Chronic Liver Disease Foundation·interventional·Posted Jul 29, 2011·Updated Jan 6, 2015

In Brief

A Phase 4 clinical trial evaluating Educational Intervention and Patient education and management skills training for Chronic Hepatitis C and Genotype 1. Completed, enrolled 197 participants across 43 sites.

Detailed Summary

The purpose of this study is to evaluate the impact of a physician directed education program on treatment compliance of hepatitis C patients administered triple drug therapy of pegylated interferon, ribavirin and boceprevir.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C, Genotype 1
CountriesUnited States
CollaboratorsSCRI Development Innovations, LLC, Merck Sharp & Dohme LLC

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 29, 2011
Enrollment StartDec 1, 2011
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 14.9 years ago

Interventions

Educational Interventionprocedure

Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes.

Patient education and management skills trainingother

Community sites received patient education and management skills training by HCEE investigators during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes.