Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-30 @ 4:12 PM
Study NCT ID:
NCT00919633
Status:
COMPLETED
Last Update Posted:
2019-10-09
First Post:
2009-06-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study to Compare Continuous Infusion of Interferon With Standard of Care for Chronic Hepatitis C
Sponsor:
Medtronic Corporate Technologies and New Ventures
Organization:
Study Overview
Official Title:
COPE-HCV: Continuous Interferon Delivery Via the Medtronic Paradigm Pump Infusion System Clinical Evaluation for Chronic HCV
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPE-HCV
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: