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
1 other identifier
interventional
60
2 countries
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2007
Typical duration for phase_1
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 21, 2007
CompletedFirst Posted
Study publicly available on registry
August 23, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedJune 8, 2011
June 1, 2011
2.6 years
August 21, 2007
June 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety
Week 52
Study Arms (2)
1
EXPERIMENTALOmega DUROS: Dose 25
2
EXPERIMENTALOmega DUROS: Dose 50
Interventions
Omega DUROS device 25mcg inserted SC for 48 weeks Omega DUROS device 50mcg inserted SC for 48 weeks
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 21, 2007
First Posted
August 23, 2007
Study Start
August 1, 2007
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
June 8, 2011
Record last verified: 2011-06