CClinicalTrials.gg
CompletedNCT00519792Updated Jun 8, 2011

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

A Phase 1 interventional study of Omega DUROS device in Chronic Hepatitis C, sponsored by Intarcia Therapeutics. Completed at 8 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-06-08.

Sponsored by Intarcia Therapeutics · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Hepatitis C

Keywords

  • Relapse
  • HCV
  • Hepatitis C
  • Interferon
  • Ribavirin
03

In context

Hepatitis A

2,710 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 60 is below the median of 100 across 1,887 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Intarcia Therapeutics is the lead sponsor of 21 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    1

    Omega DUROS: Dose 25

    Drug: Omega DUROS device

  • Experimental
    2

    Omega DUROS: Dose 50

    Drug: Omega DUROS device

Interventions

  • DrugOmega DUROS device

    Omega DUROS device 25mcg inserted SC for 48 weeks Omega DUROS device 50mcg inserted SC for 48 weeks

06

What researchers measure

Primary outcomes

  1. Safety

    Time frame: Week 52

07

Study locations

8 sites
  • Cedars-Sinai Medical Center
    Los Angeles, California 90048, United States
  • California Pacific Medical Center
    San Francisco, California 94115, United States
  • St. Louis University
    St Louis, Missouri 63110, United States
  • Weill Cornell Medical College
    New York, New York 10021, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • The Liver Institute at Methodist Dallas
    Dallas, Texas 75203, United States
  • Alamo Medical Research
    San Antonio, Texas 28215, United States
  • Fundacion de Investigacion de Diego
    San Juan, 00909, Puerto Rico
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00519792
Lead sponsor
Intarcia Therapeutics
First posted
Aug 23, 2007
Start date
Aug 2007
Primary completion
Mar 2010
Completion
Mar 2010
Last update
Jun 8, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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