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Trial record 1 of 58 for:    Atenativ | Antithrombin
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Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery

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ClinicalTrials.gov Identifier: NCT04918173
Recruitment Status : Recruiting
First Posted : June 8, 2021
Last Update Posted : September 19, 2022
Sponsor:
Information provided by (Responsible Party):
Octapharma

Brief Summary:
Assess the incidence of the composite of thrombotic events (TEs) and thromboembolic events (TEEs) in patients with congenital antithrombin deficiency under cover of Atenativ for surgical procedures or parturition.

Condition or disease Intervention/treatment Phase
Congenital Antithrombin Deficiency Drug: Atenativ Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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 Surgery or Delivery
Actual Study Start Date : July 1, 2022
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : December 1, 2024


Arm Intervention/treatment
Experimental: Atenativ treatment
Patients will receive a single intravenous infusion of Atenativ for PK analysis. Patients will receive a single intravenous dose followed by maintenance doses administered every 24 hours for approximately 2-7 days for surgical patients and approximately 5 days for parturients
Drug: Atenativ
Antithrombin concentrate




Primary Outcome Measures :
  1. Thrombotic event incidence [ Time Frame: Up to day 30 post treatment initiation ]
    The primary objective of this study is to assess the incidence of the composite of TEs and TEEs in patients with congenital antithrombin deficiency under cover of Atenativ for surgical procedures or parturition


Secondary Outcome Measures :
  1. Single dose Pharmacokinetics of Atenativ: Area under the curve (AUCnorm(0-∞)) [ Time Frame: Up to day 14 post PK infusion ]
    Assess the area under the curve (AUCnorm(0-∞)) of Atenativ in patients with congenital antithrombin deficiency

  2. Single dose Pharmacokinetics of Atenativ: Maximum plasma concentration (Cmax) [ Time Frame: Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion ]
    Assess the maximum plasma concentration (Cmax) after a single dose of Atenativ in patients with congenital antithrombin deficiency

  3. Single dose Pharmacokinetics of Atenativ: Half-life (t1/2) [ Time Frame: Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion ]
    Assess the half-life (t1/2) after a single dose of Atenativ in patients with congenital antithrombin deficiency

  4. Single dose Pharmacokinetics of Atenativ: Mean residence time (MRT) [ Time Frame: Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion ]
    Assess the mean residence time (MRT) after a single dose of Atenativ in patients with congenital antithrombin deficiency

  5. Single dose Pharmacokinetics of Atenativ: Clearance (CL) [ Time Frame: Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion ]
    Assess the clearance (CL) after a single dose of Atenativ in patients with congenital antithrombin deficiency

  6. Single dose Pharmacokinetics of Atenativ: Incremental in vivo recovery (IVR) [ Time Frame: Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion ]
    Assess the Incremental in vivo recovery after a single dose of Atenativ in patients with congenital antithrombin deficiency

  7. Single dose Pharmacokinetics of Atenativ: Volume of distribution at steady state (Vss) [ Time Frame: Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion ]
    Assess the volume of distribution at steady state (Vss) after a single dose of Atenativ in patients with congenital antithrombin deficiency

  8. Single dose Pharmacokinetics of Atenativ: Maximum Plasma Concentration (Tmax) [ Time Frame: Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion ]
    Assess the time to reach Maximum Plasma Concentration (Tmax) after a single dose of Atenativ in patients with congenital antithrombin deficiency

  9. 10. Coagulation parameters: Activated partial thromboplastin time [aPTT] [ Time Frame: Up to day 7 post treatment initiation ]
    Assess activated partial thromboplastin time [aPTT] in patients with congenital antithrombin deficiency undergoing surgical procedures or parturition

  10. Coagulation parameters: Prothrombin time [PT] [ Time Frame: Up to day 7 post treatment initiation ]
    Assess prothrombin time [PT] in patients with congenital antithrombin deficiency undergoing surgical procedures or parturition

  11. Coagulation parameters: International normalised ratio [INR] [ Time Frame: Up to day 7 post treatment initiation ]
    Assess international normalised ratio [INR] in patients with congenital antithrombin deficiency undergoing surgical procedures or parturition

  12. Coagulation parameters: Fibrinogen level [ Time Frame: Up to day 7 post treatment initiation ]
    Assess fibrinogen in patients with congenital antithrombin deficiency undergoing surgical procedures or parturition

  13. Safety and tolerability: Number of adverse events (AEs) [ Time Frame: Up to day 30 post treatment initiation ]
    Number of adverse events (AEs) following treatment with Atenativ in patients with congenital antithrombin deficiency



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 the treatment phase, if needed
  2. Level of antithrombin ≤60%
  3. Personal or family history of TEs or TEEs
  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, 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 other than the study medication 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
  13. Have participated in another investigational study within the last 30 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04918173


Contacts
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Contact: Sigurd Knaub +41554512141 Sigurd.Knaub@octapharma.com

Locations
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United States, District of Columbia
Georgetown University Recruiting
Washington, District of Columbia, United States, 20057
United States, Florida
University of Miami Not yet recruiting
Miami, Florida, United States, 33124
United States, Illinois
Rush University Medical Center Not yet recruiting
Chicago, Illinois, United States, 60612
Bleeding and Clotting Disorders Institute Recruiting
Peoria, Illinois, United States, 61615
Austria
Universitätsklinik für Innere Medizin Klinische Abteilung für Hämatologie und Hämostaseologie Not yet recruiting
Vienna, Austria
France
University Hospital of Reims Recruiting
Reims, France
Centre Hospitalier Universitaire de Rouen (CHU de Rouen) - Centre de Traitement des Maladies Hemorragiques (CRTH) (Centre d'Hemophiles) Not yet recruiting
Rouen, France
Germany
Klinik fur Angiologie Hamostaseologie Haus 12 A Gerinnungssprechstunde Not yet recruiting
Berlin, Germany
Gerinnungszentrum Rhein-Ruhr Not yet recruiting
Duisburg, Germany
Hungary
University of Debrecen, Medical and Health Science Centre Recruiting
Debrecen, Hungary
Italy
Universita degli Studi di Milano - IRCCS Ospedale Maggiore Policlinico - Centro Emofilia e Trombosi Angelo Bianchi Bonomi Not yet recruiting
Milan, Italy
University of Padua Medical School Not yet recruiting
Padua, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Not yet recruiting
Roma, Italy
Spain
Central University Hospital of Asturias Recruiting
Oviedo, Asturias, Spain, 33011
Sponsors and Collaborators
Octapharma
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Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT04918173    
Other Study ID Numbers: ATN-106
First Posted: June 8, 2021    Key Record Dates
Last Update Posted: September 19, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Antithrombin III Deficiency
Antithrombin III
Antithrombins
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Blood Protein Disorders
Thrombophilia
Genetic Diseases, Inborn
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants