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

Sponsored by:	Intarcia Therapeutics
Information provided by:	Intarcia Therapeutics
ClinicalTrials.gov Identifier:	NCT00519792

Purpose

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.

Condition	Intervention	Phase
Chronic Hepatitis C	Drug: Omega DUROS device	Phase I

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Interferons

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Intarcia Therapeutics:

Primary Outcome Measures:

Safety [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]

Enrollment:	60
Study Start Date:	August 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Omega DUROS: Dose 25	Drug: Omega DUROS device Omega DUROS device 25mcg inserted SC for 48 weeks Omega DUROS device 50mcg inserted SC for 48 weeks
2: Experimental Omega DUROS: Dose 50	Drug: Omega DUROS device Omega DUROS device 25mcg inserted SC for 48 weeks Omega DUROS device 50mcg inserted SC for 48 weeks

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00519792

Locations

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

Sponsors and Collaborators

Intarcia Therapeutics

More Information

Responsible Party:	Intarcia Therapeutics, Inc ( Intarcia Therapeutics, Inc )
Study ID Numbers:	ITCA 638-CLP-08
Study First Received:	August 21, 2007
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00519792
Health Authority:	United States: Food and Drug Administration

Keywords provided by Intarcia Therapeutics:

Relapse
HCV
Hepatitis C
Interferon
Ribavirin

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic

Interferons
Ribavirin
Hepatitis, Viral, Human
Hepatitis C
Hepatitis C, Chronic

Additional relevant MeSH terms:

RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on January 15, 2009