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Coagulation DisorderPhase 3NCT05156983

A Study of TAK-330 to Reverse the Effects of Factor Xa Inhibitors For Adults Needing Urgent Surgery

A Phase 3 study testing TAK-330 and SOC 4F-PCC in people with Coagulation Disorder, run by Takeda at 64 sites in 15 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coagulation Disorder
What is being tested?
TAK-330 and SOC 4F-PCC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
440 participants
Where
64 sitesin 15 countries
Study dates
24 Aug 2022to 30 Aug 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant or legally authorized representative willing to sign e-consent/written informed consent form.
  • Participants at least 18 years of age at enrollment.
  • Participant currently on treatment with oral Factor Xa inhibitor (rivaroxaban, apixaban, edoxaban).
  • In the opinion of the surgeon, the participant requires an urgent surgery/procedure that is associated with high-risk of intraoperative bleeding within 15 hours from the last dose of Factor Xa inhibitor and requires a reversal agent for suspected direct oral Factor Xa inhibitor-related coagulopathy. For participants who are beyond the 15-hour window, eligibility requires proof of elevated plasma anti-Factor Xa (FXa) levels using either specific direct oral anti-coagulant (DOAC)-calibrated (apixaban, rivaroxaban or edoxaban) anti-FXa levels of greater than (>) 75 nanograms per milliliter (ng/mL), or heparin calibrated anti-FXa assay levels of >0.5 international unit per milliliter (IU/mL) at screening.
  • Women of childbearing potential should have a negative pregnancy test documented prior to enrollment.

Who cannot join

  • The participant has an expected survival of less than 30 days, even with best available medical and surgical care.
  • Recent history (within 90 days prior to screening) of venous thromboembolism, myocardial infarction (MI), disseminated intravascular coagulation (DIC), ischemic stroke, transient ischemic attack, hospitalization for unstable angina pectoris or severe or critical coronavirus 2 (SARS-CoV-2) infection.
  • Active major bleeding defined as bleeding that requires surgery or transfusion of >2 units of packed red blood cell (PRBC) or intracranial hemorrhage with the exception of subacute and chronic subdural hemorrhages with a Glasgow Coma Score (GCS) greater than or equal to (>=) 9.
  • Polytrauma for which reversal of Factor Xa-inhibition alone would not be sufficient to achieve hemostasis.
  • Known prothrombotic disorder including primary antiphospholipid syndrome, antithrombin-3 deficiency, homozygous protein C deficiency, homozygous protein S deficiency, and homozygous factor V Leiden.
  • Known bleeding disorder (example, platelet function disorders, hemophilia, Von Willebrand disease, or coagulation factor deficiency).
Show all 20Show fewer
  • Platelet count less than (<) 50,000 per microliter (/mcL).
  • History of heparin-induced thrombocytopenia.
  • Administration of procoagulant drugs (example, non-study prothrombin complex concentrates (PCCs), recombinant Factor VIIa) or blood products (transfusion of whole blood, fresh frozen plasma, cryoglobulins, plasma fractions, or platelets) within 7 days before enrollment. (Note: administration of PRBCs for hemoglobin correction, tranexamic acid or aminocaproic acid are not exclusion criteria).
  • Planned use of procoagulant drugs (example, Vitamin K, non-study PCCs, recombinant Factor VIIa) or blood products (transfusion of whole blood, fresh frozen plasma, cryoglobulins, plasma fractions, or platelets) after enrollment but before the 24±4 hours hemostatic assessment (Key secondary endpoint). Planned administration of tranexamic acid (TXA) or aminocaproic acid after randomization but before the start of IP infusion, should be noted during randomization to properly stratify these participants in the interactive response technology (IRT). Planned administration of TXA or aminocaproic acid after start of IP infusion but before the 24±4 hours hemostatic assessment is prohibited. Administration of any of the above products before the 24±4 hours hemostatic assessment will impact the assessment of hemostasis. Administration of PRBCs for hemoglobin correction, is not an exclusion criterion.
  • Administration of unfractionated heparin within 2 hours before randomization or low molecular weight heparin within 6 hours before randomization.
  • Hypersensitivity to PCC constituents or any excipient of TAK-330.
  • Participants with history of confirmed immunoglobulin A (IgA) deficiency with hypersensitivity reaction and antibodies to IgA.
  • Septic shock as defined by persistent hypotension requiring vasopressors to maintain mean arterial pressure (MAP) >=65 millimeters of mercury (mmHg) and having blood lactate >2 millimole (mmol) despite adequate volume resuscitation.
  • Acute or chronic liver failure (hepatic cirrhosis Child-PUGH score C)
  • Renal failure requiring dialysis
  • Any other condition that could, in the opinion of the investigator, put the participant at undue risk of harm if the participant were to participate in the study.
  • Participation in another clinical study involving an investigational product or device within 30 days prior to study enrollment, or planned participation in another clinical study involving an investigational product or device during the course of this study. Participation in an observational study is not an exclusion criterion.
  • The use of PROTHROMPLEX TOTAL as SOC 4F-PCC.
  • Women who are breastfeeding at the time of enrollment.

Trial locations and contacts

64 sites in 15 countries. Contact the study team or a site near you to ask about taking part.

Takeda Contact contact

+1-877-825-3327

medinfoUS@takeda.com

64 sites in 15 countries

United States13 sites, 13 recruiting

  • University of Arkansas Medical Sciences

    Arkansas City, Arkansas, 72205

    Recruiting

  • Metro Health Medical Center

    Cleveland, Ohio, 44109

    Recruiting

  • Ohio State University

    Columbus, Ohio, 43210

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Recruiting

  • Denver Metro Orthopedics, P.C.

    Englewood, Colorado, 80012

    Recruiting

  • University of Florida

    Gainesville, Florida, 32608

    Recruiting

  • ECU Health Medical Center

    Greenville, North Carolina, 27858

    Recruiting

  • Rutgers, The State University of New Jersey

    New Brunswick, New Jersey, 07103

    Recruiting

  • University of Pennsylvania - Perelman School of Medicine

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • UPMC

    Pittsburgh, Pennsylvania, 15213

    Recruiting

  • University of California Davis Health System

    Sacramento, California, 95817

    Recruiting

  • Ascension St. John Medical Center

    Tulsa, Oklahoma, 74104

    Recruiting

  • Carilion Medical Center

    Virginia Beach, Virginia, 24014

    Recruiting

Other trials in United States

Israel8 sites, 8 recruiting

  • Shamir Medical Center (Assaf Harofe)

    Beer Yaacov, 70300

    Recruiting

  • Soroka Medical Center

    Beersheba, 8410101

    Recruiting

  • Rambam Health Care Campus

    Haifa, 3109601

    Recruiting

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

    Recruiting

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, 911200

    Recruiting

  • Rabin MC

    Petah Tikva, 49100

    Recruiting

  • Chaim Sheba Medical Center

    Ramat Gan, 5265601

    Recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

    Recruiting

Other trials in Israel

Canada6 sites, 6 recruiting

  • Hamilton General Hospital

    Hamilton, Ontario, L8L 2X2

    Recruiting

  • London Health Sciences Centre (LHSC) - University Hospital

    London, Ontario, N6A 5A5

    Recruiting

  • Montreal General Hospital

    Montreal, Quebec, H3G 1A4

    Recruiting

  • The Ottawa Hospital - General Campus

    Ontario, K1H 8L6

    Recruiting

  • CHU de Quebec- Hopital de l Enfant Jesus

    Québec, G1J-1Z4

    Recruiting

  • Unity Health Toronto St Michaels Hospital

    Toronto, Ontario, M5N 1W8

    Recruiting

Other trials in Canada

France5 sites, 2 recruiting

  • Hospital michallon - CHUGA

    Grenoble, 38043

    Completed

  • Hopital Marie Lannelongue

    Le Plessis-Robinson, 92350

    Completed

  • Hôpital Lariboisière

    Paris, 75010

    Completed

  • GH Paris Saint Joseph

    Paris, 75014

    Recruiting

  • CHU Strasbourg - Hopital Hautepierre

    Strasbourg, Bas Rhin, 67098

    Recruiting

Other trials in France

Argentina4 sites, 4 recruiting

  • Hospital Universitario Austral

    Buenos Aires, B1629WWA

    Recruiting

  • Clinica Zabala

    Ciudad Autonoma Buenos Aires, 1426

    Recruiting

  • Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia - FLENI

    Ciudad Autonoma Buenos Aires, CP1428

    Recruiting

  • Hospital Privado de Rosario

    Santa Fe, 3000

    Recruiting

Other trials in Argentina

Belgium4 sites, 4 recruiting

  • ZOL

    Genk, Limburg, 3600

    Recruiting

  • Jessa Ziekenhuis Hospital

    Hasselt, Limburg, 3500

    Recruiting

  • AZ Groeninge

    Kortrijk, 8500

    Recruiting

  • CHU UCL Namur

    Therasse 1, 5530

    Recruiting

Other trials in Belgium

Germany4 sites, 4 recruiting

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, Saxony, 01307

    Recruiting

  • Universitaetsklinikum Leipzig AoeR

    Leipzig, Saxony, 04103

    Recruiting

  • BG Klinikum Murnau gGmbH

    Murnau am Staffelsee, Bavaria, 82418

    Recruiting

  • Klinikum Dortmund gGmbH

    Murnau am Staffelsee, 44137

    Recruiting

Other trials in Germany

Hungary4 sites, 4 recruiting

  • Bekes Varmegyei Kozponti Korhaz

    Békéscsaba, Attica, 5700

    Recruiting

  • Semmelweis Egyetem

    Budapest, 1082

    Recruiting

  • Debreceni Egyetem

    Debrecen, 4032

    Recruiting

  • Ozdi Almasi Balogh Pal Korhaz

    Szeged, Attica, 6725

    Recruiting

Other trials in Hungary

Brazil3 sites, 3 recruiting

  • Hospital de Clinicas de Ijui

    Ijuí, 98700-000

    Recruiting

  • Irmandade da Santa Casa da Misericordia de Santos

    Santos, São Paulo, 11010-000

    Recruiting

  • Hospital Sao Paulo

    São Paulo, 5102

    Recruiting

Other trials in Brazil

Czechia3 sites, 3 recruiting

  • Fakultni nemocnice Brno

    Jihlavska, 625 00

    Recruiting

  • Fakultni nemocnice v Motole

    Prague (Praha), 15000

    Recruiting

  • Dept of II. interni klinika - gastroenterologie

    Srobarova C, 100 34

    Recruiting

Other trials in Czechia

Portugal3 sites, 3 recruiting

  • Centro Hospitalar do Baixo Vouga, E.P.E. - Unidade de Aveiro

    Aveiro, 3810-501

    Recruiting

  • Centro Hospitalar do Baixo Vouga, E.P.E. - Unidade de Aveiro

    Aveiro, 3814-501

    Recruiting

  • Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E

    Rua Conceição Fernandes, 4434-502

    Recruiting

Other trials in Portugal

Spain3 sites, 3 recruiting

  • Hospital Clinico Universitario de Salamanca

    Salamnca, Salamanca, 37007

    Recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

    Recruiting

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

    Recruiting

Other trials in Spain

Austria2 sites, 2 recruiting

  • LKH - Universitaetsklinikum Graz

    Graz, 8036

    Recruiting

  • Landesklinikum Neunkirchen

    Neunkirchen, 2620

    Recruiting

Other trials in Austria

Greece1 site, 1 recruiting

  • Konstantopoulio General Hospital, N.Ionia

    Nea Ionia, Attica, 14233

    Recruiting

Other trials in Greece

Poland1 site, 1 recruiting

  • Uniwersytecki Szpital Kliniczny nr 1 im. prof. Tadeusza Sokołowskiego PUM w Szczecinie

    Szczecin, 71-252

    Recruiting

Other trials in Poland

About this study

Official title: A Phase 3, Prospective, Randomized, Open-label, Adaptive Group Sequential, Multicenter Trial With Blinded Endpoint Assessment to Evaluate the Efficacy and Safety of TAK-330 for the Reversal of Direct Oral Factor Xa Inhibitor-induced Anticoagulation in Patients Requiring Urgent Surgery/Invasive Procedure

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.

Being tested
TAK-330, SOC 4F-PCC
Keywords
Reversal of Factor Xa inhibitors
Medical subject headings
Hemostatic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAK-330Drug

    Participants will receive TAK-330, 25 IU/kg single intravenous infusion on Day 1 and an additional dose of 25 IU/kg TAK-330 can be administered if required.

  • SOC 4F-PCCDrug

    Participants will receive 4F-PCC as SOC on Day 1. The dose and infusion speed of the SOC 4F-PCC will be based on local institutional protocols. An additional dose of SOC 4F-PCC not exceeding total dose of 50 IU/kg or 5,000 IU, whichever is smaller can be given during the surgery if required.

Study groups in NCT05156983
Study groupRoleWhat they receive
TAK-330 25 IU/kgExperimentalParticipants will receive TAK-330, 25 international unit per kilogram (IU/kg) single intravenous infusion on Day 1 (prior to surgery) as an initial dose and an additional dose of 25 IU/kg TAK-330 can be administered during the surgery if deemed necessary by the surgeon. The total dose of TAK-330 administered to the participant should not exceed 50 IU/kg or 5,000 IU, whichever is smaller.
Receives: Drug: TAK-330
SOC 4F-PCCActive comparatorParticipants will receive 4F-PCC (excluding Prothromplex Total and activated 4F-PCC) as standard of care (SOC) on Day 1 (prior to surgery). The dose and infusion speed of the SOC 4F-PCC will be based on local institutional protocols. An additional dose of SOC 4F-PCC not exceeding total dose of 50 IU/kg or 5,000 IU, whichever is smaller can be given during the surgery if required.
Receives: Drug: SOC 4F-PCC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Intraoperative Effective Hemostasis

    Percentage of participants achieving intraoperative effective hemostasis, as determined by the Intraoperative Four Point Hemostatic Efficacy Scale and assessed by the principal investigator (PI), the surgeon, or a qualified member of the surgical team.

    Measured: At the end of the surgery/procedure

Secondary outcomes (7)

  1. Percentage of Participants With Postoperative Effective Hemostasis

    Percentage of participants achieving postoperative effective hemostasis at 24±4 hours following the completion of investigational product infusion, as determined by the Postoperative Four Point Hemostatic Efficacy Scale and assessed by the PI, the surgeon, or a qualified member of the surgical team.

    Measured: At 24 hours after the end of investigational product infusion

  2. Percentage of Participants With Intraoperative Effective Hemostasis Based on Hemostatic Efficacy Rating Algorithm

    Percentage of participants achieving intraoperative effective hemostasis, as determined by the Hemostatic Efficacy Rating Algorithm and assessed by the PI, the surgeon, or a qualified member of the surgical team.

    Measured: At the end of the surgery/procedure

  3. Number of Participants With Usage of Blood Products or Non-Study Hemostatic Agents for Bleeding Control

    Number of participants with usage of blood products or non-study hemostatic agents for bleeding control will be documented from the end of IP infusion to 24 hours after end of study product infusion.

    Measured: Within 24 hours after the end of investigational product infusion

  4. Number of Units of Packed Red Blood Cells (PRBCs) Administered to Achieve Bleeding Control

    Number of units of PRBCs administered to achieve bleeding control within 24 hours after the end of IP infusion.

    Measured: Within 24 hours after the end of investigational product infusion

  5. Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESIs)

    An Adverse Event (AE) is defined as any untoward medical occurrence (including a symptom or disease or an abnormal laboratory finding) in a participant or clinical investigation participants administered a medicinal product and which does not necessarily have a causal relationship with the treatment. TEAEs are defined as those with a start date on or after the first dose of study treatment, or with a start date before the date of first dose of study treatment but increasing in severity after the first dose of study treatment. A SAE is any event that results in: death; life-threatening event; requires inpatient hospitalization or results in prolongation of existing hospitalization; persistent or significant disability/incapacity; results in a congenital anomaly/birth defect or a medically important event. AESI will include hypersensitivity reactions, events of disordered coagulation such as bleeding and hypercoagulability.

    Measured: Within 30 days after the end of the surgery/invasive procedure (up to 33 days)

  6. Number of Participants With Thrombotic Events

    Number of thrombotic events within 30 days after the end of the surgery/invasive procedure will be assessed. Thrombotic events occur when a blood clot, known as a thrombus, is formed within a blood vessel. It prevents blood from flowing normally through the circulatory system.

    Measured: Within 30 days after the end of the surgery/invasive procedure (up to 33 days)

  7. Number of Participants With Deaths Within 30 Days Post-Surgery/Invasive Procedure

    Number of deaths Within 30 days post-surgery/invasive procedure will be assessed.

    Measured: Within 30 days post-surgery/invasive procedure (up to 33 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2021
  2. Study start24 Aug 2022
  3. Primary completion30 Aug 2028 (estimated)
  4. Study completion30 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Adaptive parallel-group sequential design.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
440 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05156983
Sponsor's protocol ID
TAK-330-3001
Other IDs
2021-004138-12, 2022-503012-16-00
Status last verified
Jun 2026
First submitted
13 Dec 2021
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TAK-330 and SOC 4F-PCC in people with Coagulation Disorder, run by Takeda at 64 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in United States, Israel, Canada, France, Argentina and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Intraoperative Effective Hemostasis (time frame: At the end of the surgery/procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05156983.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.

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