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NCT05156983 · ClinicalTrials.gov registry record · Phase 3
A Study of TAK-330 to Reverse the Effects of Factor Xa Inhibitors For Adults Needing Urgent Surgery
A Phase 3 study of Coagulation Disorder, sponsored by Takeda.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 328
- Enrollment target
- 20
- Study locations
NCT05156983 is a Phase 3 study of Coagulation Disorder that is actively recruiting participants, run by Takeda. The registered enrollment target is 328 participants. The trial reports 20 study locations across 13 states.
The verdict
NCT05156983, a Phase 3 study of Coagulation Disorder, is actively recruiting participants, sponsored by Takeda.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 328 participants
- Enrollment target
- 20
- Study locations
Study Summary
The aim of this study is to find out the effects of TAK-330 compared with four-factor prothrombin complex concentrate (4F-PCC) as part of standard treatment other than Prothromplex Total for anticoagulation reversal in participants treated with Factor Xa inhibitors who require urgent surgery/invasive procedure. The participant will be assigned by chance to either TAK-330 or SOC 4F-PCC as part of standard treatment before surgery. Patients participating in this study will need to be hospitalized. They will also be contacted (via telehealth/phone call) 30 days after the surgery.
Conditions Studied
Interventions
- DRUG TAK-330
- DRUG SOC 4F-PCC
Study Locations (20)
Other
- Hospital Universitario Austral - Buenos Aires
- Clinica Zabala - Ciudad Autonoma Buenos Aires
- Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia - FLENI - Ciudad Autonoma Buenos Aires
- Hospital Privado de Rosario - Santa Fe
- LKH - Universitaetsklinikum Graz - Graz
- Landesklinikum Neunkirchen - Neunkirchen
Ohio
- Metro Health Medical Center - Cleveland
- Ohio State University - Columbus
Pennsylvania
- University of Pennsylvania - Perelman School of Medicine - Philadelphia
- UPMC - Pittsburgh
Arkansas
- University of Arkansas Medical Sciences - Arkansas City
California
- University of California Davis Health System - Sacramento
Colorado
- Denver Metro Orthopedics, P.C. - Englewood
Florida
- University of Florida - Gainesville
New Jersey
- Rutgers, The State University of New Jersey - New Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 328 participants |
| Start Date | 2022-08-24 |
| Est. Completion | 2028-04-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05156983
The ClinicalTrials.gov registry entry for NCT05156983 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 328 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Coagulation Disorder appearing as the primary indexed condition, and to 2 interventions - of which TAK-330 is the first listed.
NCT05156983 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, Ohio, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05156983 about?
NCT05156983 is a clinical study titled "A Study of TAK-330 to Reverse the Effects of Factor Xa Inhibitors For Adults Needing Urgent Surgery". The aim of this study is to find out the effects of TAK-330 compared with four-factor prothrombin complex concentrate (4F-PCC) as part of standard treatment other than Prothromplex Total for anticoagulation reversal in participants treated with Factor Xa inhibitors who require urgent surgery/invasiv...
What is the current status of trial NCT05156983?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 328 participants. The study started on 2022-08-24. Estimated completion is 2028-04-12.
What conditions does trial NCT05156983 study?
This clinical trial studies the following conditions: Coagulation Disorder.
What interventions are being tested in trial NCT05156983?
The interventions under investigation include: TAK-330 (DRUG), SOC 4F-PCC (DRUG).
Who is sponsoring clinical trial NCT05156983?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05156983 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Florida, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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