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Clinical trials for Antithrombin deficiency

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    17 result(s) found for: Antithrombin deficiency. Displaying page 1 of 1.
    EudraCT Number: 2021-004307-40 Sponsor Protocol Number: ATN-106 Start Date*: 2022-01-31
    Sponsor Name:Octapharma AG
    Full Title: A multicentre, prospective, open-label, uncontrolled Phase 3 study to assess the efficacy, safety and pharmacokinetics of Atenativ in patients with congenital antithrombin deficiency undergoing sur...
    Medical condition: Congenital antithrombin deficiency
    Disease: Version SOC Term Classification Code Term Level
    23.0 100000004850 10083881 Antithrombin deficiency LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Trial now transitioned) AT (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned) DE (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-002014-38 Sponsor Protocol Number: GTC AT HD 012-04 Start Date*: 2005-10-14
    Sponsor Name:GTC Biotherapeutics Inc.
    Full Title: A Multicenter, Multinational Study to Assess the Safety and Efficacy of Antithrombin alfa in Hereditary Antithrombin (AT) Deficient Patients in High-Risk Situations for Thrombosis
    Medical condition: Hereditary Antithrombin Deficient Patients in High risk Situations for Thrombosis.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) AT (Completed) SE (Completed) DK (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-002037-67 Sponsor Protocol Number: IG404/1 Start Date*: 2008-08-15
    Sponsor Name:Grifols Biologicals Inc.
    Full Title: EFFICACY AND SAFETY OF FACTOR IX (FIX) CONTAINED IN ALPHANINE® AND ITS PHARMACOKINETIC COMPARISON WITH BENEFIX® IN PATIENTS WITH SEVERE HEREDITARY HAEMOPHILIA B (Follow-up study of the trial IG404...
    Medical condition: HEREDITARY HAEMOPHILIA B One single pharmacokinetic to compare the pharmacokinetic profile of BeneFIX with that of AlphaNine used by the same patients in a previous trial.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10018939 Haemophilia B (Factor IX) LLT
    Population Age: Adults Gender: Male
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2019-000679-18 Sponsor Protocol Number: EFC15467 Start Date*: 2019-07-23
    Sponsor Name:Genzyme Corporation
    Full Title: ATLAS-PEDS: An open-label, multinational study of fitusiran prophylaxis in male pediatric subjects aged 1 to less than 12 years with hemophilia A or B
    Medical condition: Hemophilia A or B
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10066439 Hemophilia LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: ES (Restarted) Outside EU/EEA IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-001395-21 Sponsor Protocol Number: ALN-AT3SC-002 Start Date*: 2015-07-22
    Sponsor Name:Genzyme Corporation
    Full Title: An Open-label Extension Study of Subcutaneously Administered Fitusiran in Patients with Moderate or Severe Hemophilia A or B who have Participated in a Previous Clinical Study with Fitusiran
    Medical condition: Hemophilia A or Hemophilia B
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060613 Hemophilia A (Factor VIII) LLT
    20.0 100000004850 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) BG (Completed)
    Trial results: View results
    EudraCT Number: 2009-016720-31 Sponsor Protocol Number: 250901 Start Date*: 2010-06-09
    Sponsor Name:Baxter Innovations GmbH [...]
    1. Baxter Innovations GmbH
    2. Baxter Healthcare Corporation
    Full Title: BAX 326 (recombinant Factor IX): A Phase 1/3 Prospective, Controlled, Multicenter Study Evaluating Pharmacokinetics, Efficacy, Safety, Immunogenicity in Previously Treated Patients with Severe (FIX...
    Medical condition: Previously treated patients with severe (FIX level < 1%) or moderately severe (FIX level ≤ 2%) hemophilia B.
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10018939 Haemophilia B (Factor IX) LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) CZ (Completed) ES (Completed) BG (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2021-000099-12 Sponsor Protocol Number: APHP180617 Start Date*: 2021-10-12
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
    Full Title: Dose-adjustment of enoxaparin by a bayesian pharmacological approach in pediatric renal transplant recipients
    Medical condition: Allograft vascular thrombosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038359 - Renal and urinary disorders 10072226 Renal vascular thrombosis PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-001447-43 Sponsor Protocol Number: ALIFE2 Start Date*: 2018-10-03
    Sponsor Name:Academic Medical Center Amsterdam
    Full Title: Anticoagulants for Living Fetuses in women with recurrent miscarriage and inherited thrombophilia; ALIFE2 study
    Medical condition: recurrent miscarriage and inherited thrombophilia
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004868 10027650 Miscarriage of pregnancy LLT
    Population Age: Adults Gender: Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-002357-35 Sponsor Protocol Number: SQ147214 Start Date*: 2015-09-22
    Sponsor Name:Research, Development & Innovation Department, UHCW NHS Trust
    Full Title: Anticoagulants for Living FoEtuses in women with recurrent miscarriage and inherited thrombophilia : ALIFE 2
    Medical condition: Inherited thrombophilia in recurrent miscarriage
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2007-005100-41 Sponsor Protocol Number: IB1001-01 Start Date*: 2009-03-16
    Sponsor Name:Aptevo Europe Limited
    Full Title: Phase I/II/III Pharmacokinetic and Outcome Study of Recombinant Factor IX Product, IB1001, in Subjects with Haemophilia B
    Medical condition: Haemophilia B
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004850 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed) FR (Ongoing) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-017095-24 Sponsor Protocol Number: AOP13007 Start Date*: 2010-02-17
    Sponsor Name:AOP Orphan Pharmaceuticals AG
    Full Title: A phase III, randomized, multicenter, subject- and sponsor-blinded, placebo controlled study to compare the efficacy and safety of “Anagrelide retard” versus placebo in “at risk” subjects with Esse...
    Medical condition: male and female "at risk" subjects with Essential Thrombocythaemia
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10015493 Essential thrombocythaemia PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed) SK (Completed) SI (Completed) LT (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2010-020113-85 Sponsor Protocol Number: CSLCT-BIO-l0-67 Start Date*: 2011-09-20
    Sponsor Name:CSL Behring GmbH
    Full Title: A Multicentre, Interventional, Non-randomized, Open-label, Single-group Phase III Study to evaluate Plasma-Derived Antihaemophilic Factor/von Willebrand Factor Concentrate (Biostate®) for Immune To...
    Medical condition: Male paediatric subjects with Haemophilia A who develped high titre antibodies to human coagulation Factor VIII
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004850 10018941 Haemophilia NOS LLT
    Population Age: Infants and toddlers, Children, Under 18, Adults, Elderly Gender: Male
    Trial protocol: DE (Prematurely Ended) FR (Completed) AT (Completed) GR (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-000284-21 Sponsor Protocol Number: 524E-CVD-9101-004 Start Date*: 2007-11-08
    Sponsor Name:York Hospitals NHS Foundation Trust [...]
    1. York Hospitals NHS Foundation Trust
    2. University of York
    Full Title: A multicentre, multinational randomised control trial of prophylactic low molecular weight heparin(LMWH) in high risk pregnant thrombophilic women
    Medical condition: Thrombophilia in pregnancy. This is a multi-centre, multi-national randomised controlled trial of Low Molecular Weight Heparin to prevent pregnancy complications in high-risk pregnant thrombophi...
    Disease: Version SOC Term Classification Code Term Level
    14.0 10005329 - Blood and lymphatic system disorders 10057396 Thrombophilia LLT
    Population Age: Adults Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-000789-53 Sponsor Protocol Number: VWFC-ECMO Start Date*: 2017-03-09
    Sponsor Name:Medizinische Universität Innsbruck / Univ.-Klinik für Allgemeine und Chirurgische Intensivmedizin
    Full Title: A pilot trial to investigate the administration of von Willebrand factor concentrate (Willfact®, LFB France) in adult patients during extracorporeal membrane oxygenation
    Medical condition: Von Willebrand Disease (VWD)
    Disease: Version SOC Term Classification Code Term Level
    19.1 10005329 - Blood and lymphatic system disorders 10069495 Acquired Von Willebrand's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-003036-37 Sponsor Protocol Number: ECMO-vWFC Start Date*: 2017-10-27
    Sponsor Name:Tirol Kliniken GmbH
    Full Title: A double-blind, placebo-controlled pilot trial to investigate the administration of von Willebrand factor concentrate (Willfact®, LFB France) in adult patients during extracorporeal membrane oxygen...
    Medical condition: Von Willebrand Disease (VWD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10069495 Acquired Von Willebrand's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2009-014295-21 Sponsor Protocol Number: 998HB102 Start Date*: 2010-05-06
    Sponsor Name:Biogen Idec Hemophilia Inc.
    Full Title: B-LONG: An Open-label, Multicenter Evaluation of the Safety, Pharmacokinetics, and Efficacy of Recombinant, Long-acting Coagulation Factor IX Fc fusion protein (rFIXFc) in the Prevention and Treat...
    Medical condition: The medical condition to be investigated is Hemophilia B, or Christmas disease. Hemophilia B is a deficiency in the clotting FIX and is a recessively inherited coagulation disorder due to an X-chro...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10053754 Hemophilia B without inhibitors LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: SE (Completed) GB (Completed) DE (Completed) FR (Completed) PL (Completed) BE (Completed) IT (Completed) NL (Ongoing)
    Trial results: View results
    EudraCT Number: 2004-000193-31 Sponsor Protocol Number: PR08 Start Date*: 2004-10-04
    Sponsor Name: University College London
    Full Title: Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy
    Medical condition: Prostate Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10001186 Adenocarcinoma of prostate LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10001198 Adenocarcinoma of the prostate metastatic LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10001199 Adenocarcinoma of the prostate recurrent LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10007113 Cancer of prostate LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10007453 Carcinoma of the prostate metastatic LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10007454 Carcinoma of the prostate recurrent LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10007462 Carcinoma prostate LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060862 Prostate cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060862 Prostate cancer PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036911 Prostate cancer recurrent PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036911 Prostate cancer recurrent PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036921 Prostate carcinoma LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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