Safety and Efficacy Study to Compare Continuous Infusion of Interferon With Standard of Care for Chronic Hepatitis C (COPE-HCV)

Medtronic

Status and phase: Completed; Phase 2

Conditions: Hepatitis C

Treatments: Device: external drug infusion pump; Drug: peginterferon alfa-2b; Drug: interferon alfa-2b; Drug: ribavirin, USP

Study type: Interventional

Funder types: Industry

Identifiers

NCT00919633

4316001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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116 participants in 4 patient groups

Group 1: interferon alfa-2b (dose 1)

Experimental group

Description:

continuous subcutaneous infusion for 48 weeks

Treatment:

Drug: ribavirin, USP

Drug: interferon alfa-2b

Device: external drug infusion pump

Group 2: interferon alfa-2b (dose 2)

Experimental group

Description:

continuous subcutaneous infusion for 48 weeks

Treatment:

Drug: ribavirin, USP

Drug: interferon alfa-2b

Device: external drug infusion pump

Group 3: interferon alfa-2b (dose 3)

Experimental group

Description:

continuous subcutaneous infusion for 48 weeks

Treatment:

Drug: ribavirin, USP

Drug: interferon alfa-2b

Device: external drug infusion pump

Group 4: peginterferon alfa-2b (1.5 μg/kg)

Active Comparator group

Description:

subcutaneous weekly for 48 weeks

Treatment:

Drug: ribavirin, USP

Drug: peginterferon alfa-2b