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Safety and Efficacy Study to Compare Continuous Infusion of Interferon With Standard of Care for Chronic Hepatitis C | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT00919633•Medtronic Corporate Technologies and New Ventures

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

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

Locations (1)

Duke Clinical Research Institute

Durham, North Carolina, United States

Key Dates

Start Date

June 1, 2009

Primary Completion Date

July 1, 2012

Completion Date

July 1, 2012

Last Updated

October 9, 2019

Enrollment

116

ACTUAL participants

Conditions

Hepatitis C

Interventions

interferon alfa-2b

DRUG

peginterferon alfa-2b

DRUG

ribavirin, USP

DRUG

external drug infusion pump

DEVICE

Implementing Low-Barrier HCV Treatment in a Jail Setting

NCT06953479

HEPATITIS C (HCV)Incarceration+2 more

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RECRUITINGNA

Project I Test: Implementing HIV Testing in Opioid Treatment Programs

NCT03135886

HIV/AIDSHepatitis C+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 9, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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