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 - ND

• Conditions: Hereditary Antithrombin AT Deficient Patients in High-Risk Situations for Thrombosis; MedDRA version: 6.1Level: PTClassification code 10020608

• Registration Number: EUCTR2005-002014-38-IT
• Lead Sponsor: GTC BIOTHERAPEUTICS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-16
• 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 8804; 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.
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

The following patients will be excluded from participating in the study 1. 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 . 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 .

Study & Design

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