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

This study has been completed.
Sponsor:
Information provided by:
Intarcia Therapeutics
ClinicalTrials.gov Identifier:
NCT00519792
First received: August 21, 2007
Last updated: June 6, 2011
Last verified: June 2011
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

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
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
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
  More Information

No publications provided

Responsible Party: Intarcia Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT00519792     History of Changes
Other Study ID Numbers: ITCA 638-CLP-08
Study First Received: August 21, 2007
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Intarcia Therapeutics:
Relapse
HCV
Hepatitis C
Interferon
Ribavirin

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013