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Safety and Efficacy Study to Compare Continuous Infusion of Interferon With Standard of Care for Chronic Hepatitis C (COPE-HCV)

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
interferon alfa-2b
peginterferon alfa-2b
ribavirin, USP
external drug infusion pump
Sponsored by
Medtronic Corporate Technologies and New Ventures
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring hepatitis C, HCV, genotype, sustained virological response, rapid virological response, interferon

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke Clinical Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Group 1: interferon alfa-2b (dose 1)

Group 2: interferon alfa-2b (dose 2)

Group 3: interferon alfa-2b (dose 3)

Group 4: peginterferon alfa-2b (1.5 μg/kg)

Arm Description

continuous subcutaneous infusion for 48 weeks

continuous subcutaneous infusion for 48 weeks

continuous subcutaneous infusion for 48 weeks

subcutaneous weekly for 48 weeks

Outcomes

Primary Outcome Measures

Viral Load: Incidence of Sustained Virologic Response (SVR)

Secondary Outcome Measures

Rapid Virologic Response (RVR)
Early Virologic Response (EVR)

Full Information

First Posted
June 10, 2009
Last Updated
September 24, 2019
Sponsor
Medtronic Corporate Technologies and New Ventures
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1. Study Identification

Unique Protocol Identification Number
NCT00919633
Brief Title
Safety and Efficacy Study to Compare Continuous Infusion of Interferon With Standard of Care for Chronic Hepatitis C
Acronym
COPE-HCV
Official Title
COPE-HCV: Continuous Interferon Delivery Via the Medtronic Paradigm Pump Infusion System Clinical Evaluation for Chronic HCV
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Corporate Technologies and New Ventures

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
hepatitis C, HCV, genotype, sustained virological response, rapid virological response, interferon

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: interferon alfa-2b (dose 1)
Arm Type
Experimental
Arm Description
continuous subcutaneous infusion for 48 weeks
Arm Title
Group 2: interferon alfa-2b (dose 2)
Arm Type
Experimental
Arm Description
continuous subcutaneous infusion for 48 weeks
Arm Title
Group 3: interferon alfa-2b (dose 3)
Arm Type
Experimental
Arm Description
continuous subcutaneous infusion for 48 weeks
Arm Title
Group 4: peginterferon alfa-2b (1.5 μg/kg)
Arm Type
Active Comparator
Arm Description
subcutaneous weekly for 48 weeks
Intervention Type
Drug
Intervention Name(s)
interferon alfa-2b
Other Intervention Name(s)
INTRON® A
Intervention Description
subcutaneous continuous infusion at one of three doses for 48 weeks
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2b
Other Intervention Name(s)
PEGINTRON™
Intervention Description
1.5 μg/kg subcutaneous weekly for 48 weeks
Intervention Type
Drug
Intervention Name(s)
ribavirin, USP
Other Intervention Name(s)
Rebetol®
Intervention Description
All patients will receive oral ribavirin
Intervention Type
Device
Intervention Name(s)
external drug infusion pump
Other Intervention Name(s)
Medtronic MiniMed™ Paradigm® Insulin Pump Infusion System
Intervention Description
pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
Primary Outcome Measure Information:
Title
Viral Load: Incidence of Sustained Virologic Response (SVR)
Time Frame
24 weeks after treatment is complete
Secondary Outcome Measure Information:
Title
Rapid Virologic Response (RVR)
Time Frame
Study Week 4
Title
Early Virologic Response (EVR)
Time Frame
Study week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Muir, M.D.
Organizational Affiliation
Duke Clinical Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sarah Mische, PhD
Organizational Affiliation
Medtronic Ventures and New Therapies
Official's Role
Study Director
Facility Information:
Facility Name
Duke Clinical Research Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Links:
URL
http://ctep.cancer.gov
Description
Common terminology criteria for adverse events, version 3.0
URL
http://www.ICMJE.org
Description
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.

Learn more about this trial

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

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