Recombinant Human Antithrombin (rhAT) in Patients With Hereditary Antithrombin Deficiency Undergoing Surgery or Delivery

Completed · Phase 3

Conditions studied: Antithrombin III Deficiency

In brief

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.

Key facts

Study ID

NCT00110513

Run by

rEVO Biologics

People needed

18

Starts

2005-04-01

Expected to finish

2008-07-01

Last updated by the study team

2012-08-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• Study site — New Haven, Connecticut, United States
• Study site — St Louis, Missouri, United States
• Study site — New York, New York, United States
• Study site — North Gosford, Australia
• Study site — Vienna, Austria
• Study site — Ottawa, Ontario, Canada
• Study site — Vancouver, Canada
• Study site — Montpellier, France
• Study site — Berlin, Germany
• Study site — Alessandria, Italy
• Study site — Exeter, Devon, United Kingdom
• Study site — Chichester, West Sussex, United Kingdom
• Study site — Cambridge, United Kingdom
• Study site — Glasgow, United Kingdom
• Study site — London, United Kingdom
• Study site — Nottingham, United Kingdom
• Study site — Plymouth, United Kingdom

Full record on ClinicalTrials.gov

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