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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: interferon alfa-2b
* Drug: peginterferon alfa-2b
* Drug: ribavirin, USP
* Device: external drug infusion pump


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: interferon alfa-2b (dose 1)<br>continuous subcutaneous infusion for 48 weeks | Drug: interferon alfa-2b<br>* subcutaneous continuous infusion at one of three doses for 48 weeks<br>* Other names: INTRON® A;Drug: ribavirin, USP<br>* All patients will receive oral ribavirin<br>* Other names: Rebetol®;Device: external drug infusion pump<br>* pump delivery system for continuous subcutaneous infusion of interferon alfa-2b<br>* Other names: Medtronic MiniMed™ Paradigm® Insulin Pump Infusion System;|
| Experimental: Group 2: interferon alfa-2b (dose 2)<br>continuous subcutaneous infusion for 48 weeks | Drug: interferon alfa-2b<br>* subcutaneous continuous infusion at one of three doses for 48 weeks<br>* Other names: INTRON® A;Drug: ribavirin, USP<br>* All patients will receive oral ribavirin<br>* Other names: Rebetol®;Device: external drug infusion pump<br>* pump delivery system for continuous subcutaneous infusion of interferon alfa-2b<br>* Other names: Medtronic MiniMed™ Paradigm® Insulin Pump Infusion System;|
| Experimental: Group 3: interferon alfa-2b (dose 3)<br>continuous subcutaneous infusion for 48 weeks | Drug: interferon alfa-2b<br>* subcutaneous continuous infusion at one of three doses for 48 weeks<br>* Other names: INTRON® A;Drug: ribavirin, USP<br>* All patients will receive oral ribavirin<br>* Other names: Rebetol®;Device: external drug infusion pump<br>* pump delivery system for continuous subcutaneous infusion of interferon alfa-2b<br>* Other names: Medtronic MiniMed™ Paradigm® Insulin Pump Infusion System;|
| Active Comparator: Group 4: peginterferon alfa-2b (1.5 μg/kg)<br>subcutaneous weekly for 48 weeks | Drug: peginterferon alfa-2b<br>* 1.5 μg/kg subcutaneous weekly for 48 weeks<br>* Other names: PEGINTRON™;Drug: ribavirin, USP<br>* All patients will receive oral ribavirin<br>* Other names: Rebetol®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral Load: Incidence of Sustained Virologic Response (SVR) |  | 24 weeks after treatment is complete | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rapid Virologic Response (RVR) |  | Study Week 4 | 
| Early Virologic Response (EVR) |  | Study week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatitis C, HCV, genotype, sustained virological response, rapid virological response, interferon