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

September 24, 2019 updated by: Medtronic Corporate Technologies and New Ventures

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

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 Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

116

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke Clinical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: interferon alfa-2b (dose 1)
continuous subcutaneous infusion for 48 weeks
Drug: interferon alfa-2b
subcutaneous continuous infusion at one of three doses for 48 weeks
Other Names:
  • INTRON® A
Drug: ribavirin, USP
All patients will receive oral ribavirin
Other Names:
  • Rebetol®
Device: external drug infusion pump
pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
Other Names:
  • Medtronic MiniMed™ Paradigm® Insulin Pump Infusion System
Experimental: Group 2: interferon alfa-2b (dose 2)
continuous subcutaneous infusion for 48 weeks
Drug: interferon alfa-2b
subcutaneous continuous infusion at one of three doses for 48 weeks
Other Names:
  • INTRON® A
Drug: ribavirin, USP
All patients will receive oral ribavirin
Other Names:
  • Rebetol®
Device: external drug infusion pump
pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
Other Names:
  • Medtronic MiniMed™ Paradigm® Insulin Pump Infusion System
Experimental: Group 3: interferon alfa-2b (dose 3)
continuous subcutaneous infusion for 48 weeks
Drug: interferon alfa-2b
subcutaneous continuous infusion at one of three doses for 48 weeks
Other Names:
  • INTRON® A
Drug: ribavirin, USP
All patients will receive oral ribavirin
Other Names:
  • Rebetol®
Device: external drug infusion pump
pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
Other Names:
  • Medtronic MiniMed™ Paradigm® Insulin Pump Infusion System
Active Comparator: Group 4: peginterferon alfa-2b (1.5 μg/kg)
subcutaneous weekly for 48 weeks
Drug: ribavirin, USP
All patients will receive oral ribavirin
Other Names:
  • Rebetol®
Drug: peginterferon alfa-2b
1.5 μg/kg subcutaneous weekly for 48 weeks
Other Names:
  • PEGINTRON™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Viral Load: Incidence of Sustained Virologic Response (SVR)
Time Frame: 24 weeks after treatment is complete
24 weeks after treatment is complete

Secondary Outcome Measures

Outcome Measure
Time Frame
Rapid Virologic Response (RVR)
Time Frame: Study Week 4
Study Week 4
Early Virologic Response (EVR)
Time Frame: Study week 12
Study week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Corporate Technologies and New Ventures

Investigators

  • Principal Investigator: Andrew Muir, M.D., Duke Clinical Research Institute
  • Study Director: Sarah Mische, PhD, Medtronic Ventures and New Therapies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

June 10, 2009

First Submitted That Met QC Criteria

June 10, 2009

First Posted (Estimate)

June 12, 2009

Study Record Updates

Last Update Posted (Actual)

October 9, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4316001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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