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

Hepatitis C Clinical Trial

— COPE-HCV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00919633
• Other study ID #: 4316001
• Status: Completed
• Phase: Phase 2
• Start date: June 2009
• Est. completion date: July 2012

Study information

• Verified date: September 2019
• Source: Medtronic Corporate Technologies and New Ventures
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Signed patient consent form

• Genotype 1 chronic HCV with detectable HCV RNA

• No previous treatment for HCV infection

• Hepatitis B and human immunodeficiency virus negative at screening visit

• Able and willing to follow contraception requirements

• Screening laboratory values, test, and physical exam within acceptable ranges

• Weight between 40 kg and 125 kg

• Proficiency in the use of the external pump infusion system

Exclusion Criteria:

• Current or planned enrollment in another investigational device or drug study

• Anticipated inability to complete all clinic visits and comply with study procedures

• History of, or any current medical condition, which could impact the safety of the subject during the study

• Autoimmune hepatitis, suspected hepatocellular carcinoma, decompensated liver disease, or other known liver disease other than HCV

• Alcoholism or substance abuse with <6 documented months of sobriety

• Known allergy or sensitivity to interferons or ribavirin

• Any other condition that, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• interferon alfa-2b
subcutaneous continuous infusion at one of three doses for 48 weeks
• peginterferon alfa-2b
1.5 µg/kg subcutaneous weekly for 48 weeks
• ribavirin, USP
All patients will receive oral ribavirin

Device:
• external drug infusion pump
pump delivery system for continuous subcutaneous infusion of interferon alfa-2b

Locations

Country	Name	City	State
United States	Duke Clinical Research Institute	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Corporate Technologies and New Ventures

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral Load: Incidence of Sustained Virologic Response (SVR)		24 weeks after treatment is complete
Secondary	Rapid Virologic Response (RVR)		Study Week 4
Secondary	Early Virologic Response (EVR)		Study week 12

External Links

•   Common terminology criteria for adverse events, version 3.0
•   International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication. Publication ethics: sponsorship, authorship and accountability.
•   Viral cancers: Hepatitis C