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New hope for rare clotting disorder: drug aims to prevent dangerous clots during surgery and delivery

NCT ID NCT04918173

Disease control Sponsor: Octapharma 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called Atenativ in people with a rare inherited condition that raises their risk of dangerous blood clots. The goal is to see if Atenativ can prevent clots during surgery or childbirth. About 38 adults and some teens will take part. The drug is given as an infusion to replace a missing protein that normally prevents clotting.

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 38 people

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

Started

Jul 2022

Expected to finish

Dec 2026

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

12 to 80 years

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: 1. Adult male or female patients ≥18 and ≤80 years of age. Solely in the US, 4 male or female patients between ≥12 and \<17 years of age will be enrolled into the PK phase, and subsequently in the treatment phase, if applicable 2. Documented congenital antithrombin deficiency, defined by plasma activity level of antithrombin ≤60% from medical history 3. Personal or family history of TEs or TEEs (except for PK patients) 4. For the Treatment Phase: either a) non-pregnant surgical patients scheduled for elective surgical procedure(s) known to be associated with a high risk for occurrence of TEs or TEEs, or b) pregnant patients of at least 27 weeks gestational age who are scheduled for caesarean section or delivery 5. For female patients of childbearing potential entering the PK Phase who are not known to be pregnant, and for female surgical patients of childbearing potential entering the Treatment Phase for any procedure other than caesarean section or delivery, a negative urine pregnancy test at screening and at baseline 6. Patient has provided informed consent Exclusion Criteria: 1. Requires emergency surgery or emergency caesarean section 2. Has undergone surgery within the last 6 weeks 3. History or suspicion of another hereditary thrombophilic disorder other than antithrombin deficiency (e.g., activated protein C \[APC\] resistance/Factor V Leiden, Protein S or C deficiency, prothrombin gene mutation \[G20210A\], or acquired \[lupus anticoagulant\] thrombophilic disorder) 4. Malignancies, renal failure (patients on renal replacement therapy), or severe liver disease (aspartate aminotransferase \[ASAT\] \>5 times the upper limit of normal) 5. Body mass index \>40 kg/m2 (for non-pregnant patients, only) 6. Known hypersensitivity or allergic reaction to antithrombin or any of the excipients in Atenativ 7. History of anaphylactic reaction(s) to blood or blood components 8. Refusal to receive transfusion of blood-derived products 9. Administration of any antithrombin concentrate or antithrombin-containing blood product within 14 days of either of the two phases of the study 10. Prior diagnosis of heparin-induced thrombocytopenia 11. TE or TEE within the last 6 months 12. Female patients who are nursing at the time of screening\* 13. Have participated in another investigational study within the last 30 days 14. Persons dependent on the sponsor, the investigator or the centre of investigation 15. Persons placed in an institution by administrative or judicial order * criterion does not include female patients who plan to breastfeed after giving birth

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Conditions

The condition(s) this trial relates to.

hereditary antithrombin deficiency

As listed by the trial registrant

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

Congenital antithrombin deficiency

How to take part

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

  1. The places running it

    30 sites in 14 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Aversi Clinic

    RECRUITING

    Tbilisi, Georgia

  • Bleeding and Clotting Disorders Institute

    RECRUITING

    Peoria, Illinois, 61615, United States

  • Central University Hospital of Asturias

    RECRUITING

    Oviedo, Principality of Asturias, 33011, Spain

  • Centre Hospitalier Universitaire de Rouen (CHU de Rouen) - Centre de Traitement des Maladies Hemorragiques (CRTH) (Centre d'Hemophiles)

    RECRUITING

    Rouen, France

  • Centre de Référence de l'Hémophilie Unité d'Hémostase Clinique Hôpital Cardiologique Louis Pradel

    RECRUITING

    Bron, France

  • Centre for Thrombosis and Haemaostasis

    RECRUITING

    Nymburk, Czechia

  • Clinical Center of Serbia

    RECRUITING

    Belgrade, Serbia

  • Duke University

    RECRUITING

    Durham, North Carolina, 27708, United States

  • Emergency County Hospital Craiova

    RECRUITING

    Craiova, Romania

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    RECRUITING

    Roma, Italy

  • Georgetown University

    RECRUITING

    Washington D.C., District of Columbia, 20057, United States

  • Gerinnungszentrum Rhein-Ruhr

    RECRUITING

    Duisburg, Germany

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario Morales Meseguer

    RECRUITING

    Murcia, Spain

  • Klinik fur Angiologie Hamostaseologie Haus 12 A Gerinnungssprechstunde

    RECRUITING

    Berlin, Germany

  • Ourense University Hospital

    RECRUITING

    Ourense, 32005, Spain

  • Rabin Medical Centre, Institute of Haematology

    RECRUITING

    Petah Tikva, Israel

  • Royal-free Hospital-Katherine Dormandy Haemophilia and Thrombosis Centre

    RECRUITING

    London, United Kingdom

  • Sheba Medical Centre

    RECRUITING

    Ramat Gan, Israel

  • St. Thomas Hospital

    RECRUITING

    London, United Kingdom

  • UKB Bonn Institut für Experimentelle Hämatologie und Transfusionsmedizin

    RECRUITING

    Bonn, Germany

  • Unita Strutturale Complessa di Immunoematologia e Medicina Trasfusionale -Dipartimento Interaziendale di Medicina Trasfusionale ed Ematologia - ASST Papa Giovanni XXIII ematologia Piazza OMS, 1

    RECRUITING

    Bergamo, 24127, Italy

  • Universita degli Studi di Milano - IRCCS Ospedale Maggiore Policlinico - Centro Emofilia e Trombosi Angelo Bianchi Bonomi

    RECRUITING

    Milan, Italy

  • University Hospital of Reims

    RECRUITING

    Reims, France

  • University of Debrecen, Medical and Health Science Centre

    RECRUITING

    Debrecen, Hungary

  • University of Miami

    RECRUITING

    Miami, Florida, 33124, United States

  • University of Padua Medical School

    RECRUITING

    Padua, Italy

  • Universitätsklinik für Innere Medizin Klinische Abteilung für Hämatologie und Hämostaseologie

    RECRUITING

    Vienna, Austria

  • Weill Cornell Medicine

    RECRUITING

    New York, New York, 10065, United States

  • Yeolyan Hematology and Oncology Centre

    RECRUITING

    Yerevan, Armenia