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

NCT00919633 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2019-10-09

Study results available
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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.

Conditions

  • Hepatitis C

Interventions

DRUG

interferon alfa-2b

subcutaneous continuous infusion at one of three doses for 48 weeks

DRUG

peginterferon alfa-2b

1.5 μg/kg subcutaneous weekly for 48 weeks

DRUG

ribavirin, USP

All patients will receive oral ribavirin

DEVICE

external drug infusion pump

pump delivery system for continuous subcutaneous infusion of interferon alfa-2b

Sponsors & Collaborators

  • Medtronic Corporate Technologies and New Ventures

    lead INDUSTRY

Principal Investigators

  • Andrew Muir, M.D. · Duke Clinical Research Institute

  • Sarah Mische, PhD · Medtronic Ventures and New Therapies

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00919633 on ClinicalTrials.gov