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

Completed · Phase 1

Conditions studied: Chronic Hepatitis C

In brief

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.

Key facts

Study ID

NCT00519792

Run by

Intarcia Therapeutics

People needed

60

Starts

2007-08-01

Expected to finish

2010-03-01

Last updated by the study team

2011-06-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chronic Hepatitis C with HCV genotype 1 infection
• Relapse following an end of treatment response after treatment with a pegylated interferon and ribavirin.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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