CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 601 enrolled
Drug / intervention
Peginterferon alfa-2b (SCH 54031) +2 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.

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NCT00704522N/ACompleted
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Evaluation of Adherence Rate in Patients Receiving PegIntron Pen / Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program.

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

In Brief

An observational study evaluating Peginterferon alfa-2b (SCH 54031), Ribavirin (SCH 18908), and 1 other intervention for Hepatitis C, Chronic and Hepacivirus. Completed, enrolled 601 participants.

Detailed Summary

Patients receiving a patient assistance program during therapy for Hepatitis C will be enrolled into this study. All patients will receive PegIntron pen and Rebetol according to label and the patient assistance program. This study will be compared to similar studies from other clinics using various patient support programs for the purpose of designing future comparative phase IV studies.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic, Hepacivirus
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 25, 2008
Enrollment StartMar 1, 2005
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 18.0 years ago

Interventions

Peginterferon alfa-2b (SCH 54031)biological

Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.

Ribavirin (SCH 18908)drug

Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.

Patient assistance programbehavioral

Assistance programs will be classified as follows: 1. Medications used prophylactically or for treatment(Growth factors: RBC and neutrophil; Psychiatric medications; Other medications) 2. Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature). In Austria, sites with adherence nurses and side effect handouts will be compared with sites using side effect handouts only.