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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

Page last updated: June 20, 2008

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