Safety and Efficacy Study to Compare Continuous Infusion of Interferon With Standard of Care for Chronic Hepatitis C
NCT ID: NCT00919633
Last Updated: 2019-10-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
116 participants
INTERVENTIONAL
2009-06-30
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group 1: interferon alfa-2b (dose 1)
continuous subcutaneous infusion for 48 weeks
interferon alfa-2b
subcutaneous continuous infusion at one of three doses for 48 weeks
ribavirin, USP
All patients will receive oral ribavirin
external drug infusion pump
pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
Group 2: interferon alfa-2b (dose 2)
continuous subcutaneous infusion for 48 weeks
interferon alfa-2b
subcutaneous continuous infusion at one of three doses for 48 weeks
ribavirin, USP
All patients will receive oral ribavirin
external drug infusion pump
pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
Group 3: interferon alfa-2b (dose 3)
continuous subcutaneous infusion for 48 weeks
interferon alfa-2b
subcutaneous continuous infusion at one of three doses for 48 weeks
ribavirin, USP
All patients will receive oral ribavirin
external drug infusion pump
pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
Group 4: peginterferon alfa-2b (1.5 μg/kg)
subcutaneous weekly for 48 weeks
peginterferon alfa-2b
1.5 μg/kg subcutaneous weekly for 48 weeks
ribavirin, USP
All patients will receive oral ribavirin
Interventions
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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
external drug infusion pump
pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Medtronic Corporate Technologies and New Ventures
INDUSTRY
Responsible Party
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Principal Investigators
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Andrew Muir, M.D.
Role: PRINCIPAL_INVESTIGATOR
Duke Clinical Research Institute
Sarah Mische, PhD
Role: STUDY_DIRECTOR
Medtronic Ventures and New Therapies
Locations
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Duke Clinical Research Institute
Durham, North Carolina, United States
Countries
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Related Links
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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.
Other Identifiers
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4316001
Identifier Type: -
Identifier Source: org_study_id
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