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

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Omega DUROS device
Sponsored by
Intarcia Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Relapse, HCV, Hepatitis C, Interferon, Ribavirin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Medical Center
  • California Pacific Medical Center
  • St. Louis University
  • Weill Cornell Medical College
  • Duke University Medical Center
  • The Liver Institute at Methodist Dallas
  • Alamo Medical Research
  • Fundacion de Investigacion de Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Omega DUROS: Dose 25

Omega DUROS: Dose 50

Outcomes

Primary Outcome Measures

Safety

Secondary Outcome Measures

Full Information

First Posted
August 21, 2007
Last Updated
June 6, 2011
Sponsor
Intarcia Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00519792
Brief Title
Phase 1b Study of Omega DUROS® in Patients With Chronic Hepatitis C Who Relapsed After Prior 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 Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Intarcia Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
Relapse, HCV, Hepatitis C, Interferon, Ribavirin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Omega DUROS: Dose 25
Arm Title
2
Arm Type
Experimental
Arm Description
Omega DUROS: Dose 50
Intervention Type
Drug
Intervention Name(s)
Omega DUROS device
Intervention Description
Omega DUROS device 25mcg inserted SC for 48 weeks Omega DUROS device 50mcg inserted SC for 48 weeks
Primary Outcome Measure Information:
Title
Safety
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
St. Louis University
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The Liver Institute at Methodist Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
Alamo Medical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
28215
Country
United States
Facility Name
Fundacion de Investigacion de Diego
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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