Study to Assess Recombinant Human Antithrombin in Patients With Hereditary Antithrombin Deficiency Undergoing Surgery or Delivery - Tabular View

Tracking Information
First Received Date ^ICMJE	March 17, 2003
Last Updated Date	January 30, 2007
Start Date ^ICMJE	December 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00056550 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study to Assess Recombinant Human Antithrombin in Patients With Hereditary Antithrombin Deficiency Undergoing Surgery or Delivery
Official Title ^ICMJE	A Multicenter, Multinational Study to Assess the Incidence of Deep Vein Thrombosis (DVT) Following Prophylactic Intravenous Administration of Recombinant Human Antithrombin (rh AT) to Hereditary AT Deficient Patients in High-Risk Situations.
Brief 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. The study will test the efficacy of recombinant human antithrombin by infusing rh AT prior to, during and following the period of risk or surgical procedure.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Prevention, Non-Randomized, Open Label, Efficacy Study
Condition ^ICMJE	Hereditary Antithrombin Deficiency
Intervention ^ICMJE	Drug: Recombinant Human Antithrombin
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Have congenital AT deficiency with a personal or family history of venous thrombotic events. Have a history of congenital AT deficiency that includes 2 or more plasma AT activity levels of ≤ 60% normal. Are scheduled to have an elective procedure known to be associated with a high risk for occurrence of Deep Venous Thrombosis (DVT). This will include surgical patients or pregnant patients scheduled for cesarean section or delivery induction. In addition, hospitalized pregnant HD patients in active labor will be allowed into the study. Are at least 18 years of age, not exceeding 70 years of age. Have signed an informed consent form. Have a negative serum pregnancy test at screening and negative urine pregnancy test at baseline. This only applies to female surgical patients (not scheduled for cesarean section) of childbearing potential. Are able to comply with the requirements of the study protocol. Exclusion Criteria: Patients who have a diagnosis of hereditary APC resistance, Factor V Leiden, Protein S or C deficiency, prothrombin gene mutation (G20210A), or acquired (lupus anticoagulant) thrombophilic disorder. Patients who are scheduled for a neurosurgical procedure or open-heart surgery. Patients who have an underlying medical condition, which in the opinion of the investigator, could complicate the assessment of the incidence of DVT. Patients who have a known allergy to goats or goat products. Patients who have participated in a study employing an investigational drug within 30 days of the start of their participation in the current trial. Patients using fondaparinux sodium, or are expected to be treated with fondaparinux sodium during the study period.
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00056550
Responsible Party
Study ID Numbers ^ICMJE	GTC AT III 01002
Study Sponsor ^ICMJE	GTC Biotherapeutics
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	GTC Biotherapeutics
Verification Date	May 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP