Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00069511
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2003-09-29
Brief Title:
12 Week Study of Anti-Viral Effect of Oral UT-231B in Non-cirrhotic Hepatitis C Patients who have Failed Interferon-based Therapy
Sponsor:
United Therapeutics
Organization:
Unither Pharmaceuticals
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2004-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-center study Neither the study subjects nor the physicians will know what treatment an individual subject is receiving Subjects will be randomly assigned like flipping a coin to one of five treatment groups The treatment groups include four different dosing groups of active study drug and one group of subjects who will receive placebo A 12 week follow up period occurs after the 12 weeks of dosing The study endpoint is a reduction in Hepatitis C viral load
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