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

• Conditions: Hereditary Antithrombin Deficient Patients in High risk Situations for Thrombosis.

• Registration Number: EUCTR2005-002014-38-DK
• Lead Sponsor: GTC Biotherapeutics Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-02
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Inclusion criteria require that study patients:
1. Have 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% of normal.
3. Be scheduled to have an elective procedure(s) known to be associated with high risk for occurrence of DVT. 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 to exceed an age of 80 years.
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Excluded patients include:
1. Patients who have a diagnosis of another hereditary thrombophilic disorder [e.g., APC resistance/Factor V Leiden, Protein S or C deficiency, prothrombin gene mutation (G20210A), 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).

In addition, hospitalized pregnant HD patients in active labor and eligible HD patients previously treated with rhAT will be allowed entry into the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified