Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New reversal agent TAK-330 aims to stop bleeding in emergency surgeries

NCT ID NCT05156983

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests TAK-330, a drug designed to reverse the effects of common blood thinners (Factor Xa inhibitors) in patients who need urgent surgery. About 440 adults will be randomly assigned to receive TAK-330 or standard care before their procedure. The main goal is to see if TAK-330 helps control bleeding during surgery better than current treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TAK-330 (a reversal agent for blood thinners)
What this could lead to
If successful, TAK-330 could provide a faster, more reliable way to reverse blood thinners before emergency surgery, reducing bleeding complications.
What could go wrong
This is an early Phase 3 trial with 440 participants, so results may not apply to everyone. There is also a risk that TAK-330 may not work better than current standard treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 440 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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). * 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Coagulation disorder are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

acquired coagulation factor deficiency blood coagulation disease vascular hemostatic disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coagulation disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    61 sites in 15 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AZ Groeninge

    RECRUITING

    Kortrijk, 8500, Belgium

  • Ascension St. John Medical Center

    RECRUITING

    Tulsa, Oklahoma, 74104, United States

  • BG Klinikum Murnau gGmbH

    RECRUITING

    Murnau am Staffelsee, Bavaria, 82418, Germany

  • Bekes Varmegyei Kozponti Korhaz

    RECRUITING

    Békéscsaba, Attica, 5700, Hungary

  • CHU Strasbourg - Hopital Hautepierre

    RECRUITING

    Strasbourg, Bas Rhin, 67098, France

  • CHU UCL Namur

    RECRUITING

    Therasse 1, 5530, Belgium

  • CHU de Quebec- Hopital de l Enfant Jesus

    RECRUITING

    Québec, G1J-1Z4, Canada

  • Carilion Medical Center

    RECRUITING

    Virginia Beach, Virginia, 24014, United States

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

    RECRUITING

    Rua Conceição Fernandes, 4434-502, Portugal

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

    RECRUITING

    Aveiro, 3810-501, Portugal

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

    RECRUITING

    Aveiro, 3814-501, Portugal

  • Chaim Sheba Medical Center

    RECRUITING

    Ramat Gan, 5265601, Israel

  • Clinica Zabala

    RECRUITING

    Ciudad Autonoma Buenos Aires, 1426, Argentina

  • Debreceni Egyetem

    RECRUITING

    Debrecen, 4032, Hungary

  • Denver Metro Orthopedics, P.C.

    RECRUITING

    Englewood, Colorado, 80012, United States

  • Dept of II. interni klinika - gastroenterologie

    RECRUITING

    Srobarova C, 100 34, Czechia

  • ECU Health Medical Center

    RECRUITING

    Greenville, North Carolina, 27858, United States

  • Fakultni nemocnice Brno

    RECRUITING

    Jihlavska, 625 00, Czechia

  • Fakultni nemocnice v Motole

    RECRUITING

    Prague (Praha), 15000, Czechia

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

    RECRUITING

    Ciudad Autonoma Buenos Aires, CP1428, Argentina

  • GH Paris Saint Joseph

    RECRUITING

    Paris, 75014, France

  • Hadassah University Hospital - Ein Kerem

    RECRUITING

    Jerusalem, 911200, Israel

  • Hamilton General Hospital

    RECRUITING

    Hamilton, Ontario, L8L 2X2, Canada

  • Hopital Marie Lannelongue

    COMPLETED

    Le Plessis-Robinson, 92350, France

  • Hospital Clinico Universitario de Salamanca

    RECRUITING

    Salamnca, Salamanca, 37007, Spain

  • Hospital Clinico Universitario de Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hospital Privado de Rosario

    RECRUITING

    Santa Fe, 3000, Argentina

  • Hospital Sao Paulo

    RECRUITING

    São Paulo, 5102, Brazil

  • Hospital Universitari i Politecnic La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario Austral

    RECRUITING

    Buenos Aires, B1629WWA, Argentina

  • Hospital de Clinicas de Ijui

    RECRUITING

    Ijuí, 98700-000, Brazil

  • Hospital michallon - CHUGA

    COMPLETED

    Grenoble, 38043, France

  • Hôpital Lariboisière

    COMPLETED

    Paris, 75010, France

  • Irmandade da Santa Casa da Misericordia de Santos

    RECRUITING

    Santos, São Paulo, 11010-000, Brazil

  • Jessa Ziekenhuis Hospital

    RECRUITING

    Hasselt, Limburg, 3500, Belgium

  • Klinikum Dortmund gGmbH

    RECRUITING

    Murnau am Staffelsee, 44137, Germany

  • Konstantopoulio General Hospital, N.Ionia

    RECRUITING

    Nea Ionia, Attica, 14233, Greece

  • LKH - Universitaetsklinikum Graz

    RECRUITING

    Graz, 8036, Austria

  • Landesklinikum Neunkirchen

    RECRUITING

    Neunkirchen, 2620, Austria

  • London Health Sciences Centre (LHSC) - University Hospital

    RECRUITING

    London, Ontario, N6A 5A5, Canada

  • Metro Health Medical Center

    RECRUITING

    Cleveland, Ohio, 44109, United States

  • Montreal General Hospital

    RECRUITING

    Montreal, Quebec, H3G 1A4, Canada

  • Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Ozdi Almasi Balogh Pal Korhaz

    RECRUITING

    Szeged, Attica, 6725, Hungary

  • Rabin MC

    RECRUITING

    Petah Tikva, 49100, Israel

  • Rambam Health Care Campus

    RECRUITING

    Haifa, 3109601, Israel

  • Rutgers, The State University of New Jersey

    RECRUITING

    New Brunswick, New Jersey, 07103, United States

  • Semmelweis Egyetem

    RECRUITING

    Budapest, 1082, Hungary

  • Shaare Zedek Medical Center

    RECRUITING

    Jerusalem, 9103102, Israel

  • Shamir Medical Center (Assaf Harofe)

    RECRUITING

    Beer Yaacov, 70300, Israel

  • Soroka Medical Center

    RECRUITING

    Beersheba, 8410101, Israel

  • Tel Aviv Sourasky Medical Center

    RECRUITING

    Tel Aviv, 6423906, Israel

  • The Ottawa Hospital - General Campus

    RECRUITING

    Ontario, K1H 8L6, Canada

  • UPMC

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • Unity Health Toronto St Michaels Hospital

    RECRUITING

    Toronto, Ontario, M5N 1W8, Canada

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    RECRUITING

    Dresden, Saxony, 01307, Germany

  • Universitaetsklinikum Leipzig AoeR

    RECRUITING

    Leipzig, Saxony, 04103, Germany

  • University of Arkansas Medical Sciences

    RECRUITING

    Arkansas City, Arkansas, 72205, United States

  • University of California Davis Health System

    RECRUITING

    Sacramento, California, 95817, United States

  • University of Florida

    RECRUITING

    Gainesville, Florida, 32608, United States

  • University of Pennsylvania - Perelman School of Medicine

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

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

    RECRUITING

    Szczecin, 71-252, Poland

  • ZOL

    RECRUITING

    Genk, Limburg, 3600, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.