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

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ClinicalTrials.gov Identifier: NCT00919633
Recruitment Status : Completed
First Posted : June 12, 2009
Results First Posted : April 30, 2014
Last Update Posted : April 30, 2014
Sponsor:
Information provided by (Responsible Party):
Medtronic Corporate Technologies and New Ventures

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.

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

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  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: COPE-HCV: Continuous Interferon Delivery Via the Medtronic Paradigm Pump Infusion System Clinical Evaluation for Chronic HCV
Study Start Date : June 2009
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon

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 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®




Primary Outcome Measures :
  1. Viral Load: Incidence of Sustained Virologic Response (SVR) [ Time Frame: 24 weeks after treatment is complete ]
  2. Safety/Tolerability [ Time Frame: Through study week 72 ]

Secondary Outcome Measures :
  1. Rapid Virologic Response (RVR) [ Time Frame: Study Week 4 ]
  2. Early Virologic Response (EVR) [ Time Frame: Study week 12 ]
  3. End-of-treatment Response (EOT) [ Time Frame: Study week 48 ]
  4. Pharmacokinetics [ Time Frame: through Study Week 72 ]
  5. Pharmacodynamics [ Time Frame: through Study Week 72 ]
  6. Functional Health, Depression Score, and Fatigue Level [ Time Frame: through Study Week 72 ]
  7. Viral Decay [ Time Frame: 12 weeks of treatment ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Medtronic Corporate Technologies and New Ventures
ClinicalTrials.gov Identifier: NCT00919633     History of Changes
Other Study ID Numbers: 4316001
First Posted: June 12, 2009    Key Record Dates
Results First Posted: April 30, 2014
Last Update Posted: April 30, 2014
Last Verified: March 2014

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 C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Interferon-alpha
Peginterferon alfa-2b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs