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

Completed · Phase 2

Conditions studied: Hepatitis C

In brief

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.

Key facts

Study ID

NCT00919633

Run by

Medtronic Corporate Technologies and New Ventures

People needed

116

Starts

2009-06-01

Expected to finish

2012-07-01

Last updated by the study team

2019-10-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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