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

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medtronic Corporate Technologies and New Ventures
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2b; Ribavirin

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