Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00519792
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2007-08-21
Brief Title:
Phase 1b Study of Omega DUROS in Patients With Chronic Hepatitis C Who Relapsed After Prior Treatment
Sponsor:
Intarcia Therapeutics
Organization:
Intarcia Therapeutics
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None