Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-30 @ 5:37 PM
Study NCT ID:
NCT00119457
Status:
COMPLETED
Last Update Posted:
2009-06-03
First Post:
2005-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factor IX Inhibition in Thrombosis Prevention (The FIXIT Trial)
Sponsor:
vTv Therapeutics
Organization:
Study Overview
Official Title:
A Multi-Center, Placebo-Controlled Evaluation of the Safety and Efficacy of Three Weeks Extended VTE Prophylaxis With Daily Oral Doses of TTP889 After One Week of Standard Prophylactic Treatment Following Hip Fracture Surgery
Status:
COMPLETED
Status Verified Date:
2009-06
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:
The purpose of this study is to determine whether TTP889 prevents venous thromboembolism following surgery to repair hip fracture.
Detailed Description:
FIXIT is the first Phase 2 study of TTP889. The trial is a proof-of-concept study to determine the safety and antithrombotic efficacy of TTP889 in patients at risk for venous thromboembolism (VTE). The study is a multi-center, randomized, double-blind, parallel-group evaluation of 300 mg TTP889 or placebo, administered orally once daily for three weeks, in patients who have undergone surgery to repair unilateral fracture of the upper third of either femur and who have completed 5 to 9 days of postoperative prophylactic treatment for VTE.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Eudract CT#2004-002511-83 | None | None | View |