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

NCT00919633 | Completed Phase 2 Results DMC

• 1 other identifier: 4316001
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Keywords

hepatitis C; HCV; genotype; sustained virological response; rapid virological response; interferon

Outcome Measures

Primary Outcomes (1)

• Viral Load: Incidence of Sustained Virologic Response (SVR)

  24 weeks after treatment is complete

Secondary Outcomes (2)

• Rapid Virologic Response (RVR)

  Study Week 4

• Early Virologic Response (EVR)

  Study week 12

Study Arms (4)

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

EXPERIMENTAL

continuous subcutaneous infusion for 48 weeks

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

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

EXPERIMENTAL

continuous subcutaneous infusion for 48 weeks

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

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

EXPERIMENTAL

continuous subcutaneous infusion for 48 weeks

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

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

ACTIVE COMPARATOR

subcutaneous weekly for 48 weeks

Drug: peginterferon alfa-2b; Drug: ribavirin, USP

Interventions

interferon alfa-2b DRUG

subcutaneous continuous infusion at one of three doses for 48 weeks

Also known as: INTRON® A

Group 1: interferon alfa-2b (dose 1); Group 2: interferon alfa-2b (dose 2); Group 3: interferon alfa-2b (dose 3)

peginterferon alfa-2b DRUG

1.5 μg/kg subcutaneous weekly for 48 weeks

Also known as: PEGINTRON™

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

ribavirin, USP DRUG

All patients will receive oral ribavirin

Also known as: Rebetol®

Group 1: interferon alfa-2b (dose 1); Group 2: interferon alfa-2b (dose 2); Group 3: interferon alfa-2b (dose 3); Group 4: peginterferon alfa-2b (1.5 μg/kg)

external drug infusion pump DEVICE

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

Also known as: Medtronic MiniMed™ Paradigm® Insulin Pump Infusion System

Group 1: interferon alfa-2b (dose 1); Group 2: interferon alfa-2b (dose 2); Group 3: interferon alfa-2b (dose 3)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Corporate Technologies and New Ventures: lead

Study Sites (1)

Duke Clinical Research Institute

Durham, North Carolina, 27705, United States

Location

Related Links

• Common terminology criteria for adverse events, version 3.0
• International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication. Publication ethics: sponsorship, authorship and accountability.

MeSH Terms

Conditions

Hepatitis C

Interventions

Interferon alpha-2; peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Study Trial Manager
• Organization: Medtronic, Inc.

sarah.mische@medtronic.com

763-505-4594

Study Officials

• Andrew Muir, M.D.

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

• Sarah Mische, PhD

  Medtronic Ventures and New Therapies

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2009
• First Posted: June 12, 2009
• Study Start: June 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: October 9, 2019
• Results First Posted: April 30, 2014

Record last verified: 2019-09

Locations

US (1)