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

• Sponsor: Intarcia Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00519792
• Collaborator: (none)
• Enrollment: 60
• Locations: 8
• Arms: 2
• Duration (Months): 31
• Patients Per Site: 7.5
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C	Drug: Omega DUROS device	Phase 1

Study Design

• Study Type: Interventional
• 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: Aug 1, 2007
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Safety [Week 52]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
2	California Pacific Medical Center	San Francisco	California	United States	94115
3	St. Louis University	St Louis	Missouri	United States	63110
4	Weill Cornell Medical College	New York	New York	United States	10021
5	Duke University Medical Center	Durham	North Carolina	United States	27710
6	The Liver Institute at Methodist Dallas	Dallas	Texas	United States	75203
7	Alamo Medical Research	San Antonio	Texas	United States	28215
8	Fundacion de Investigacion de Diego	San Juan		Puerto Rico	00909

Sponsors and Collaborators

• Intarcia Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00519792
• Other Study ID Numbers: ITCA 638-CLP-08
• First Posted: Aug 23, 2007
• Last Update Posted: Jun 8, 2011
• Last Verified: Jun 1, 2011

• Keywords provided by , ,: Relapse; HCV; Hepatitis C; Interferon; Ribavirin
• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic

Study Results

No Results Posted as of Jun 8, 2011