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

Phase 2

Completed

• Conditions: Hepatitis C
• Interventions: Drug: interferon alfa-2b; Drug: peginterferon alfa-2b; Drug: ribavirin, USP; Device: external drug infusion pump

• Registration Number: NCT00919633
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-10
• Study First Submitted QC: 2009-06-10
• Study First Posted: 2009-06-12
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Results First Submitted: 2014-03-28
• Results First Submitted QC: 2014-03-28
• Results First Posted: 2014-04-30
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3: interferon alfa-2b (dose 3)	ribavirin, USP	continuous subcutaneous infusion for 48 weeks
Group 1: interferon alfa-2b (dose 1)	external drug infusion pump	continuous subcutaneous infusion for 48 weeks
Group 2: interferon alfa-2b (dose 2)	external drug infusion pump	continuous subcutaneous infusion for 48 weeks
Group 3: interferon alfa-2b (dose 3)	external drug infusion pump	continuous subcutaneous infusion for 48 weeks
Group 2: interferon alfa-2b (dose 2)	ribavirin, USP	continuous subcutaneous infusion for 48 weeks
Group 1: interferon alfa-2b (dose 1)	ribavirin, USP	continuous subcutaneous infusion for 48 weeks
Group 3: interferon alfa-2b (dose 3)	interferon alfa-2b	continuous subcutaneous infusion for 48 weeks
Group 4: peginterferon alfa-2b (1.5 μg/kg)	ribavirin, USP	subcutaneous weekly for 48 weeks
Group 4: peginterferon alfa-2b (1.5 μg/kg)	peginterferon alfa-2b	subcutaneous weekly for 48 weeks
Group 1: interferon alfa-2b (dose 1)	interferon alfa-2b	continuous subcutaneous infusion for 48 weeks
Group 2: interferon alfa-2b (dose 2)	interferon alfa-2b	continuous subcutaneous infusion for 48 weeks

Primary Outcome Measures

Name	Time	Method
Viral Load: Incidence of Sustained Virologic Response (SVR)	24 weeks after treatment is complete

Secondary Outcome Measures

Name	Time	Method
Early Virologic Response (EVR)	Study week 12
Rapid Virologic Response (RVR)	Study Week 4

Trial Locations

Locations (1)

Duke Clinical Research Institute; 🇺🇸 Durham, North Carolina, United States