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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002014-38-GB

Enrollment

Registered

2005-09-14

Start date

2005-10-14

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hereditary Antithrombin Deficient Patients in High risk Situations for Thrombosis.

Interventions

Product Name: ATryn Pharmaceutical Form: Intravenous infusion INN or Proposed INN: antithrombin alfa CAS Number: 84720-88-7 Other descri

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Excluded patients include: 1. Patients who have a diagnosis of Protein S or C 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the incidence of thromboembolic events [acute deep venous thrombosis (DVT) and/or thromboembolic events other than acute DVT] following prophylactic intravenous (IV) administration of rhAT to patients with hereditary AT deficiency (HD) in situations usually associated with a high risk for thromboembolic events.; Secondary Objective: 1. To assess the incidence of acute DVT following prophylactic IV administration of rhAT to patients with hereditary AT deficiency in situations usually associated with a high risk for thromboembolic events. 2. To assess the incidence of thromboembolic events other than acute DVT following prophylactic IV administration of rhAT to patients with hereditary AT deficiency in situations usually associated with a high risk for thromboembolic events. 3. To assess the safety, including the occurrence of anti-rhAT antibodies, in patients following treatment with rhAT. ; Primary end point(s): The first outcome assessment is a clinical diagnosis of the occurrence of acute DVT. An acute DVT will be considered to have occurred if, during rhAT treatment or within 7 days of discontinuation of treatment with rhAT: 1. Clinical symptoms consistent with the occurrence of an acute DVT are present. Clinical symptoms of acute DVT can be calf pain, swelling/edema, redness, venous distention, or pain on dorsiflexion. AND 2. Confirmation of acute DVT is obtained by diagnostic imaging (e.g. ultrasound, venography, CT). The second outcome assessment is a clinical diagnosis of the occurrence of a thromboembolic event other than DVT (e.g., pulmonary embolism). A thromboembolic event other than DVT will be considered to have occurred if, during rhAT treatment or within 7 days of discontinuation of treatment with rhAT: 1. Clinical symptoms consistent with the occurrence of a thromboembolic event other	—

Measure

Time frame

Main Objective: To assess the incidence of thromboembolic events [acute deep venous thrombosis (DVT) and/or thromboembolic events other than acute DVT] following prophylactic intravenous (IV) administration of rhAT to patients with hereditary AT deficiency (HD) in situations usually associated with a high risk for thromboembolic events.; Secondary Objective: 1. To assess the incidence of acute DVT following prophylactic IV administration of rhAT to patients with hereditary AT deficiency in situations usually associated with a high risk for thromboembolic events. 2. To assess the incidence of thromboembolic events other than acute DVT following prophylactic IV administration of rhAT to patients with hereditary AT deficiency in situations usually associated with a high risk for thromboembolic events. 3. To assess the safety, including the occurrence of anti-rhAT antibodies, in patients following treatment with rhAT. ; Primary end point(s): The first outcome assessment is a clinical diagnosis of the occurrence of acute DVT. An acute DVT will be considered to have occurred if, during rhAT treatment or within 7 days of discontinuation of treatment with rhAT: 1. Clinical symptoms consistent with the occurrence of an acute DVT are present. Clinical symptoms of acute DVT can be calf pain, swelling/edema, redness, venous distention, or pain on dorsiflexion. AND 2. Confirmation of acute DVT is obtained by diagnostic imaging (e.g. ultrasound, venography, CT). The second outcome assessment is a clinical diagnosis of the occurrence of a thromboembolic event other than DVT (e.g., pulmonary embolism). A thromboembolic event other than DVT will be considered to have occurred if, during rhAT treatment or within 7 days of discontinuation of treatment with rhAT: 1. Clinical symptoms consistent with the occurrence of a thromboembolic event other

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Countries

Austria, Denmark, Germany, Italy, Sweden, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026