Recombinant Human Antithrombin (rhAT) in Patients With Hereditary Antithrombin Deficiency Undergoing Surgery or Delivery
Information source: GTC Biotherapeutics
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Antithrombin III Deficiency
Intervention: Recombinant Human Antithrombin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: GTC Biotherapeutics
Summary
Patients with hereditary antithrombin deficiency are at increased risk of venous thrombosis
and pulmonary embolism, particularly during certain high risk procedures. The trial is
focusing on patients with confirmed hereditary antithrombin deficiency who are undergoing a
surgical procedure or induced/spontaneous labor and delivery, and/or C-section. The study
will assess 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.
Clinical Details
Official 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
Study design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Detailed description:
GTC will establish a clinical trial site in any location in Europe, Canada and the US
depending on the needs of the physician and the patient. To provide this flexibility, GTC
has an international clinical team to support site registration requirements once a patient
has been identified for treatment. We also provide consultation to help evaluate patient
eligibility.
In September 2006, GTC modified exclusion criteria 1 (below) to allow for the participation
of previously excluded patients with the hereditary thrombophilic disorders Factor V Leiden
and prothrombin gene mutation (G20210A).
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Have hereditary antithrombin deficiency (HD) with a personal history of venous
thromboembolic events.
2. Have a history of HD that includes 2 or more plasma AT activity values ≤ 60%.
3. Be scheduled to have an elective procedure(s) known to be associated with a high risk
for occurrence of a thromboembolic event. This will include non-pregnant surgical
patients or pregnant patients scheduled for caesarean section or delivery induction.
4. Be at least 18 years of age, not exceeding 80 years of age.
5. Have signed an informed consent form.
6. 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.
7. 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 will be allowed entry into the study.
Exclusion Criteria:
1. Patients who have a diagnosis of Protein S of C deficiency or acquired (lupus
anticoagulant) thrombophilic disorder.
2. 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 or have signs or symptoms of acute venous thrombosis at baseline.
3. Patients who have a known allergy to goats or goat products.
4. 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.
5. 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).
Locations and Contacts
North Gosford, Australia
Montpellier, France
Berlin, Germany
Alessandria, Italy
Nottingham, United Kingdom
Cambridge, United Kingdom
London, United Kingdom
Plymouth, United Kingdom
Glasgow, United Kingdom
Ottawa, Ontario, Canada
Additional Information
Additional information on hereditary antithrombin disease
Starting date: April 2005
Last updated: February 28, 2008
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