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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Corporate Technologies and New Ventures
ClinicalTrials.gov Identifier:
NCT00919633
First received: June 10, 2009
Last updated: December 17, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Hepatitis C
 Drug: interferon alfa-2b
Drug: peginterferon alfa-2b
Drug: ribavirin, USP
Device: external drug infusion pump
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: COPE-HCV: Continuous Interferon Delivery Via the Medtronic Paradigm Pump Infusion System Clinical Evaluation for Chronic HCV

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medtronic Corporate Technologies and New Ventures:

Primary Outcome Measures:
  • Viral Load: incidence of sustained virologic response (SVR) [ Time Frame: 24 weeks after treatment is complete ] [ Designated as safety issue: No ]
  • Safety/tolerability [ Time Frame: Through study week 72 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rapid virologic response (RVR) [ Time Frame: Study Week 4 ] [ Designated as safety issue: No ]
  • Early virologic response (EVR) [ Time Frame: Study week 12 ] [ Designated as safety issue: No ]
  • End-of-treatment response (EOT) [ Time Frame: Study week 48 ] [ Designated as safety issue: No ]
  • Pharmacokinetics [ Time Frame: through Study Week 72 ] [ Designated as safety issue: No ]
  • Pharmacodynamics [ Time Frame: through Study Week 72 ] [ Designated as safety issue: No ]
  • Functional health, depression score, and fatigue level [ Time Frame: through Study Week 72 ] [ Designated as safety issue: No ]
  • Viral decay [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 116
Study Start Date: June 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: INTRON® A
Drug: ribavirin, USP
All patients will receive oral ribavirin
Other Name: Rebetol®
Device: external drug infusion pump
pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
Other Name: 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 Name: INTRON® A
Drug: ribavirin, USP
All patients will receive oral ribavirin
Other Name: Rebetol®
Device: external drug infusion pump
pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
Other Name: 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 Name: INTRON® A
Drug: ribavirin, USP
All patients will receive oral ribavirin
Other Name: Rebetol®
Device: external drug infusion pump
pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
Other Name: Medtronic MiniMed™ Paradigm® Insulin Pump Infusion System
Active Comparator: Group 4: peginterferon alfa-2b (1.5 μg/kg)
subcutaneous weekly for 48 weeks
 Drug: peginterferon alfa-2b
1.5 μg/kg subcutaneous weekly for 48 weeks
Other Name: PEGINTRON™
Drug: ribavirin, USP
All patients will receive oral ribavirin
Other Name: Rebetol®

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919633

Locations
United States, North Carolina
Duke Clinical Research Institute
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
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
  More Information

Additional Information:
Viral cancers: Hepatitis C  This link exits the ClinicalTrials.gov site
Common terminology criteria for adverse events, version 3.0  This link exits the ClinicalTrials.gov site
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.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medtronic Corporate Technologies and New Ventures
ClinicalTrials.gov Identifier: NCT00919633     History of Changes
Other Study ID Numbers: 4316001
Study First Received: June 10, 2009
Last Updated: December 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Corporate Technologies and New Ventures:
hepatitis C
HCV
genotype
 sustained virological response
rapid virological response
interferon

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon-alpha
Interferon Alfa-2a
 Interferon Alfa-2b
Interferons
Ribavirin
Peginterferon alfa-2b
Reaferon
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013