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NCT00519792 Clinical Trial

Phase 1b Study of Omega DUROS® in Patients With Chronic Hepatitis C Who Relapsed After Prior Treatment

Chronic Hepatitis C Clinical Trial

Official title:
Phase Ib Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Omega DUROS® and Ribavirin in Subjects With Chronic Hepatitis C Previously Treated With Pegylated Interferon and Ribavirin

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00519792
Other study ID # ITCA 638-CLP-08
Secondary ID
Status Completed
Phase Phase 1
First received August 21, 2007
Last updated June 6, 2011
Start date August 2007
Est. completion date March 2010

Study information
Verified date June 2011
Source Intarcia Therapeutics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Omega DUROS® is an implantable drug delivery system designed to deliver omega interferon subcutaneously at a constant rate for 90 days.

This study is being performed to evaluate the safety and antiviral effects of omega interferon delivered by the Omega DUROS® device in combination with ribavirin in subjects with chronic Hepatitis C genotype 1.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Chronic Hepatitis C with HCV genotype 1 infection

- Relapse following an end of treatment response after treatment with a pegylated interferon and ribavirin.

Exclusion Criteria:

- Presence or history of non-HCV chronic liver disease

- Treatment with any interferon subsequent to the relapse with pegylated interferon-alpha and ribavirin

- Decompensated liver disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Omega DUROS device
Omega DUROS device 25mcg inserted SC for 48 weeks Omega DUROS device 50mcg inserted SC for 48 weeks

Locations
Country Name City State
Puerto Rico Fundacion de Investigacion de Diego San Juan
United States The Liver Institute at Methodist Dallas Dallas Texas
United States Duke University Medical Center Durham North Carolina
United States Cedars-Sinai Medical Center Los Angeles California
United States Weill Cornell Medical College New York New York
United States Alamo Medical Research San Antonio Texas
United States California Pacific Medical Center San Francisco California
United States St. Louis University St Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
Intarcia Therapeutics

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety Week 52 Yes
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