CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 116 enrolled
Drug / intervention
interferon alfa-2b +3 moredrug
Likely dose
peginterferon alfa-2b 1.5 μgfrom 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/NCT00919633
NCT00919633Phase 2Completed
CompareCT.gov

COPE-HCV: Continuous Interferon Delivery Via the Medtronic Paradigm Pump Infusion System Clinical Evaluation for Chronic HCV

Medtronic Corporate Technologies and New Ventures·interventional·Posted Jun 12, 2009·Updated Oct 9, 2019

In Brief

A Phase 2 clinical trial evaluating interferon alfa-2b, peginterferon alfa-2b, and 2 other interventions for Hepatitis C. Completed, enrolled 116 participants across 1 site.

Detailed Summary

The purpose of the study is to evaluate if continuous subcutaneous delivery of interferon alfa-2b using an external drug pump in combination with the use of oral ribavirin provides a safe and effective treatment for patients with chronic hepatitis C infection as compared to patients who receive standard treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 12, 2009
Enrollment StartJun 1, 2009
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 17.1 years ago

Interventions

interferon alfa-2bdrug

subcutaneous continuous infusion at one of three doses for 48 weeks

peginterferon alfa-2bdrug

1.5 μg/kg subcutaneous weekly for 48 weeks

ribavirin, USPdrug

All patients will receive oral ribavirin

external drug infusion pumpdevice

pump delivery system for continuous subcutaneous infusion of interferon alfa-2b