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

Sponsor:	GTC Biotherapeutics
Information provided by:	GTC Biotherapeutics
ClinicalTrials.gov Identifier:	NCT00056550

Purpose

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.

Condition	Intervention	Phase
Hereditary Antithrombin Deficiency	Drug: Recombinant Human Antithrombin	Phase III

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Efficacy Study
Official Title:	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.

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia factor V Leiden thrombophilia hemophilia hereditary antithrombin deficiency prothrombin thrombophilia

MedlinePlus related topics: Deep Vein Thrombosis Surgery

Drug Information available for: Antithrombin III

U.S. FDA Resources

Further study details as provided by GTC Biotherapeutics:

Study Start Date:

December 2002

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

Additional Information:

Additional information on hereditary antithrombin disease This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	GTC AT III 01002
Study First Received:	March 17, 2003
Last Updated:	January 30, 2007
ClinicalTrials.gov Identifier:	NCT00056550 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GTC Biotherapeutics:

Antithrombin Deficiency, Congenital
Antithrombin III Deficiency
atiii

Additional relevant MeSH terms:

Serine Proteinase Inhibitors
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Hematologic Diseases
Blood Protein Disorders
Blood Coagulation Disorders
Thrombophilia
Hematologic Agents

Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors
Antithrombin III Deficiency
Blood Coagulation Disorders, Inherited
Genetic Diseases, Inborn
Therapeutic Uses
Antithrombin III

ClinicalTrials.gov processed this record on November 09, 2009