Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-09 @ 12:20 PM
Study NCT ID:
NCT03088358
Status:
COMPLETED
Last Update Posted:
2017-03-23
First Post:
2017-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of TeaRx Xa Factor Direct Inhibitor Versus Enoxaparin as a Venous Thromboembolic Events (VTE) Prevention Following Total Knee Replacement
Sponsor:
TeaRx LLC
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Pilot, Dose-Ranging Clinical Study to Evaluate Safety and Efficacy of TeaRx Xa Factor Direct Inhibitor Versus Enoxaparin as a Venous Thromboembolic Events (VTE) Prevention Following Total Knee Replacement
Status:
COMPLETED
Status Verified Date:
2017-03
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:
To evaluate influence of therapy on the following efficacy and safety parameters in different TeaRx dose groups and Enoxaparin group:
* Total venous thromboembolic events (VTE), which includes confirmed deep venous thrombosis (DVT), nonfatal pulmonary embolism (PE), and total mortality
* Incidence of DVT (total, proximal, distal)
* Incidence of nonfatal PE
* Incidence of symptomatic VTE (DVT, PE)
* VTE caused mortality
* Non-VTE caused mortality
* Incidence of all hemorrhagic complications
* Incidence of major and clinically relevant non-major bleeding
* Adverse events (AEs) and serious adverse events (SAEs) from subject complaints, physical examination, vital signs, laboratory results
* Total venous thromboembolic events (VTE), which includes confirmed deep venous thrombosis (DVT), nonfatal pulmonary embolism (PE), and total mortality
* Incidence of DVT (total, proximal, distal)
* Incidence of nonfatal PE
* Incidence of symptomatic VTE (DVT, PE)
* VTE caused mortality
* Non-VTE caused mortality
* Incidence of all hemorrhagic complications
* Incidence of major and clinically relevant non-major bleeding
* Adverse events (AEs) and serious adverse events (SAEs) from subject complaints, physical examination, vital signs, laboratory results
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: