Recombinant Human Antithrombin (rhAT) in Patients With Hereditary Antithrombin Deficiency Undergoing Surgery or Delivery
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
1 other identifier
interventional
18
7 countries
16
Brief Summary
Patients with hereditary antithrombin deficiency are at increased risk of venous thrombosis and pulmonary embolism, particularly during certain high risk procedures. The trial focused on patients with confirmed hereditary antithrombin deficiency who were undergoing a surgical procedure or induced/spontaneous labor and delivery, and/or caesarean section. The study assessed the incidence of thromboembolic events following prophylactic intravenous administration of recombinant human antithrombin (rhAT) to patients with hereditary antithrombin (AT) deficiency in situations usually associated with a high risk for thromboembolic events.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2005
Typical duration for phase_3
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 10, 2005
CompletedFirst Posted
Study publicly available on registry
May 11, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedResults Posted
Study results publicly available
May 11, 2012
CompletedAugust 17, 2012
August 1, 2012
3.1 years
May 10, 2005
March 19, 2012
August 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Thromboembolic Events Acute Deep Venous Thrombosis (DVT) and/or Thromboembolic Events Other Than Acute Deep Venous Thrombosis (DVT)
To assess the incidence of thromboembolic events acute deep venous thrombosis (DVT) and/or thromboembolic events other than acute deep venous thrombosis (DVT) by clinical signs and symptoms of venous thromboembolism (VTE), confirmed by diagnostic assessments.
During treatment and follow up period of 7 days
Study Arms (1)
Recombinant Human Antithrombin (rhAT) Infusion
EXPERIMENTALIntravenous infusion of rhAT.
Interventions
Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient will receive an initial intravenous loading dose followed by a continuous intravenous infusion of recombinant human antithrombin (rhAT) that will target and maintain an AT activity that is \> 80% and \< 120% of normal. The dosing objective for all study patients is maintenance of the AT activity at \> 80% and \< 120% of normal during the high-risk period for thromboembolic events. Dosing and dose adjustments will be based on the results of AT activity determinations performed prior to and during treatment.
Eligibility Criteria
You may qualify if:
- Have hereditary antithrombin deficiency (HD) with a personal history of venous thromboembolic events.
- Have a history of HD that includes 2 or more plasma AT activity values ≤ 60%.
- Be scheduled to have an elective procedure(s) known to be associated with a high risk for occurrence for DVT. This will include non-pregnant surgical patients or pregnant patients scheduled for caesarean section or delivery induction.
- Be at least 18 years of age, not exceeding 80 years of age.
- Have signed an informed consent form.
- Have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline. This applies only to female non-pregnant surgical patients of childbearing potential.
- Are able to comply with the requirements of the study protocol.
- In addition, hospitalized pregnant HD patients in active labor and eligible HD patients previously treated with rhAT were allowed entry into the study.
You may not qualify if:
- Patients who have a diagnosis of another hereditary thrombophilic disorder (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).
- Patients who have a baseline bilateral ultrasound positive for acute DVT or baseline diagnostic testing (if required) that is positive for a thromboembolic event other than acute DVT.
- Patients who have a known allergy to goats or goat products.
- Patients who have participated in a study employing a different investigational drug within 30 days of the start of their participation in the current trial.
- Patients using fondaparinux sodium or the oral thrombin inhibitor, ximelagatran, or are expected to be treated with fondaparinux sodium or ximelagatran during the study period (up to 7 days after stop of treatment).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- rEVO Biologicslead
Study Sites (17)
Unknown Facility
New Haven, Connecticut, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
New York, New York, United States
Unknown Facility
North Gosford, Australia
Unknown Facility
Vienna, Austria
Unknown Facility
Ottawa, Ontario, Canada
Unknown Facility
Vancouver, Canada
Unknown Facility
Montpellier, France
Unknown Facility
Berlin, Germany
Unknown Facility
Alessandria, Italy
Unknown Facility
Exeter, Devon, United Kingdom
Unknown Facility
Chichester, West Sussex, United Kingdom
Unknown Facility
Cambridge, United Kingdom
Unknown Facility
Glasgow, United Kingdom
Unknown Facility
London, United Kingdom
Unknown Facility
Nottingham, United Kingdom
Unknown Facility
Plymouth, United Kingdom
Related Publications (1)
DeJongh J, Frieling J, Lowry S, Drenth HJ. Pharmacokinetics of recombinant human antithrombin in delivery and surgery patients with hereditary antithrombin deficiency. Clin Appl Thromb Hemost. 2014 May;20(4):355-64. doi: 10.1177/1076029613516188. Epub 2013 Dec 11.
PMID: 24335249DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Denise Tilton, RN, MHA, Director Clinical Affairs
- Organization
- GTC Biotherapeutics
Study Officials
- PRINCIPAL INVESTIGATOR
Robert C Tait, MD
Glasgow Royal Infirmary
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2005
First Posted
May 11, 2005
Study Start
April 1, 2005
Primary Completion
May 1, 2008
Study Completion
July 1, 2008
Last Updated
August 17, 2012
Results First Posted
May 11, 2012
Record last verified: 2012-08