Actively Recruiting
Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery
Led by Octapharma · Updated on 2025-11-21
38
Participants Needed
30
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this study is to assess the incidence of the composite of thrombotic events (TEs) and thromboembolic events (TEEs) in patients with congenital antithrombin deficiency under when they receive Atenativ for surgical procedures or parturition.
CONDITIONS
Official Title
Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years; in the US, patients aged 12 to under 17 may be enrolled in the pharmacokinetic phase
- Documented congenital antithrombin deficiency with plasma activity level of 60% or less
- Personal or family history of thrombotic or thromboembolic events (except for pharmacokinetic phase patients)
- For treatment: non-pregnant patients scheduled for elective high-risk surgery or pregnant patients at least 27 weeks gestation scheduled for cesarean section or delivery
- For females of childbearing potential entering pharmacokinetic or treatment phases, negative urine pregnancy test at screening and baseline
- Provided informed consent
You will not qualify if you...
- Requires emergency surgery or emergency cesarean section
- Surgery within the last 6 weeks
- History or suspicion of other hereditary thrombophilic disorders besides antithrombin deficiency
- Malignancies, renal failure on replacement therapy, or severe liver disease
- Body mass index over 40 kg/m2 (non-pregnant patients only)
- Known allergy to antithrombin or any component of Atenativ
- History of anaphylaxis to blood or blood products
- Refusal to receive blood-derived products
- Antithrombin concentrate or blood product administration within 14 days prior to study phases
- Prior diagnosis of heparin-induced thrombocytopenia
- Thrombotic or thromboembolic event within the last 6 months
- Nursing females at screening (excluding those planning to breastfeed after birth)
- Participation in another investigational study within the last 30 days
- Dependence on the sponsor, investigator, or study center
- Institutionalization by administrative or judicial order
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 locations
1
Georgetown University
Washington D.C., District of Columbia, United States, 20057
Actively Recruiting
2
University of Miami
Miami, Florida, United States, 33124
Actively Recruiting
3
Bleeding and Clotting Disorders Institute
Peoria, Illinois, United States, 61615
Actively Recruiting
4
Weill Cornell Medicine
New York, New York, United States, 10065
Actively Recruiting
5
Duke University
Durham, North Carolina, United States, 27708
Actively Recruiting
6
Yeolyan Hematology and Oncology Centre
Yerevan, Armenia
Not Yet Recruiting
7
Universitätsklinik für Innere Medizin Klinische Abteilung für Hämatologie und Hämostaseologie
Vienna, Austria
Actively Recruiting
8
Centre for Thrombosis and Haemaostasis
Nymburk, Czechia
Actively Recruiting
9
Centre de Référence de l'Hémophilie Unité d'Hémostase Clinique Hôpital Cardiologique Louis Pradel
Bron, France
Actively Recruiting
10
University Hospital of Reims
Reims, France
Actively Recruiting
11
Centre Hospitalier Universitaire de Rouen (CHU de Rouen) - Centre de Traitement des Maladies Hemorragiques (CRTH) (Centre d'Hemophiles)
Rouen, France
Actively Recruiting
12
Aversi Clinic
Tbilisi, Georgia
Actively Recruiting
13
Klinik fur Angiologie Hamostaseologie Haus 12 A Gerinnungssprechstunde
Berlin, Germany
Actively Recruiting
14
UKB Bonn Institut für Experimentelle Hämatologie und Transfusionsmedizin
Bonn, Germany
Actively Recruiting
15
Gerinnungszentrum Rhein-Ruhr
Duisburg, Germany
Actively Recruiting
16
University of Debrecen, Medical and Health Science Centre
Debrecen, Hungary
Actively Recruiting
17
Rabin Medical Centre, Institute of Haematology
Petah Tikva, Israel
Actively Recruiting
18
Sheba Medical Centre
Ramat Gan, Israel
Actively Recruiting
19
Unita Strutturale Complessa di Immunoematologia e Medicina Trasfusionale -Dipartimento Interaziendale di Medicina Trasfusionale ed Ematologia - ASST Papa Giovanni XXIII ematologia Piazza OMS, 1
Bergamo, Italy, 24127
Actively Recruiting
20
Universita degli Studi di Milano - IRCCS Ospedale Maggiore Policlinico - Centro Emofilia e Trombosi Angelo Bianchi Bonomi
Milan, Italy
Actively Recruiting
21
University of Padua Medical School
Padua, Italy
Actively Recruiting
22
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Actively Recruiting
23
Emergency County Hospital Craiova
Craiova, Romania
Actively Recruiting
24
Clinical Center of Serbia
Belgrade, Serbia
Actively Recruiting
25
Central University Hospital of Asturias
Oviedo, Principality of Asturias, Spain, 33011
Actively Recruiting
26
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
27
Hospital Universitario Morales Meseguer
Murcia, Spain
Actively Recruiting
28
Ourense University Hospital
Ourense, Spain, 32005
Actively Recruiting
29
Royal-free Hospital-Katherine Dormandy Haemophilia and Thrombosis Centre
London, United Kingdom
Actively Recruiting
30
St. Thomas Hospital
London, United Kingdom
Actively Recruiting
Research Team
S
Sigurd Knaub
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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