Trials / Completed
CompletedNCT00519792
Phase 1b Study of Omega DUROS® in Patients With Chronic Hepatitis C Who Relapsed After Prior Treatment
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Intarcia Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Omega DUROS device | Omega DUROS device 25mcg inserted SC for 48 weeks Omega DUROS device 50mcg inserted SC for 48 weeks |
Timeline
- Start date
- 2007-08-01
- Primary completion
- 2010-03-01
- Completion
- 2010-03-01
- First posted
- 2007-08-23
- Last updated
- 2011-06-08
Locations
8 sites across 2 countries: United States, Puerto Rico
Source: ClinicalTrials.gov record NCT00519792. Inclusion in this directory is not an endorsement.