NCT00919633

Safety and Efficacy Study to Compare Continuous Infusion of Interferon With Standard of Care for Chronic Hepatitis C

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Medtronic Corporate Technologies and New Ventures · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will include patients who are diagnosed with chronic hepatitis C genotype 1 infection and who have received no previous interferon or other anti-HCV treatment.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	interferon alfa-2b	subcutaneous continuous infusion at one of three doses for 48 weeks
DRUG	peginterferon alfa-2b	1.5 μg/kg subcutaneous weekly for 48 weeks
DRUG	ribavirin, USP	All patients will receive oral ribavirin
DEVICE	external drug infusion pump	pump delivery system for continuous subcutaneous infusion of interferon alfa-2b

Timeline

• Start date: 2009-06-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2009-06-12
• Last updated: 2019-10-09
• Results posted: 2014-04-30

Locations

1 site across 1 country: United States