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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00519792
Recruitment Status : Completed
First Posted : August 23, 2007
Last Update Posted : June 8, 2011
Information provided by:
Intarcia Therapeutics

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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: Omega DUROS device Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 2007
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
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

Experimental: 2
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

Primary Outcome Measures :
  1. Safety [ Time Frame: Week 52 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00519792

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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
California Pacific Medical Center
San Francisco, California, United States, 94115
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
The Liver Institute at Methodist Dallas
Dallas, Texas, United States, 75203
Alamo Medical Research
San Antonio, Texas, United States, 28215
Puerto Rico
Fundacion de Investigacion de Diego
San Juan, Puerto Rico, 00909
Sponsors and Collaborators
Intarcia Therapeutics
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Responsible Party: Intarcia Therapeutics, Inc Identifier: NCT00519792    
Other Study ID Numbers: ITCA 638-CLP-08
First Posted: August 23, 2007    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: June 2011
Keywords provided by Intarcia Therapeutics:
Hepatitis C
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections