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Assess Incidence of Deep Vein Thrombosis(DVT)Following Administration of Recombinant Human Antithrombin (rhAT) to Hereditary Antithrombin(AT) Deficient Patients in High Risk Situations. (rhAT)

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ClinicalTrials.gov Identifier: NCT00056550
Recruitment Status : Completed
First Posted : March 18, 2003
Results First Posted : October 16, 2012
Last Update Posted : October 16, 2012
Sponsor:
Information provided by (Responsible Party):
rEVO Biologics

Study Description
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Brief Summary:
Patients with hereditary antithrombin (AT) 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 safety and efficacy of recombinant human antithrombin (rhAT) by infusing rhAT prior to, during and following the period of risk or surgical procedure.

Condition or disease Intervention/treatment Phase
Antithrombin Deficiency, Congenital Biological: Recombinant Human Antithrombin (rhAT) Phase 3

Detailed Description:

Objectives :

  1. Assess the safety of recombinant antithrombin (rhAT) in hereditary antithrombin (AT) deficient patients.
  2. Assess the incidence of acute deep venous thrombosis(DVT) alone in patients with hereditary antithrombin (AT) deficiency in situations usually associated with a high risk for thromboembolic events after increasing and targeting functional AT activity at >80% and < 120% of normal by prophylactic IV administration of rhAT.
  3. Clinically assess and determine the relevance of thromboembolic events other than acute DVT to rhAT administration.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Study to Assess the Incidence of Deep Vein Thrombosis (DVT) Following Prophylactic Intravenous Administration of Recombinant Human Antithrombin(rhAT) to Hereditary Antithrombin (AT) Deficient Patients in High Risk Situations.
Study Start Date : December 2002
Actual Primary Completion Date : February 2004
Actual Study Completion Date : February 2004

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Recombinant Human Antithrombin (rhAT) infusion
Loading and continuous infusion dose of rhAT to target and maintain an AT activity level > 80% and < 120% of normal.
 Biological: Recombinant Human Antithrombin (rhAT)
Biological/Vaccine: Recombinant human antithrombin(rhAT) Phase III clinical trial.
Other Name: ATryn


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Thromboembolic Events Acute Deep Venous Thrombosis (DVT) and/or Thromboembolic Events Other Than Acute Deep Vein Thrombosis (DVT). [ Time Frame: Baseline, last day of dosing and day 7 (+ or - 1 day) ]
    Observation for clinical signs and symptoms of thromboembolic events are evaluated for acute deep vein thrombosis (DVT) using duplex ultrasonography and/or other imaging tests to confirm clinical signs/symptoms. Duplex ultrasonography was performed at baseline, last day of dosing and day 7 (+ or -1 day).


Secondary Outcome Measures :
  1. Local Assessment of Thromboembolism by Physical Examination. [ Time Frame: 30 days after last dose ]
    The investigators evaluated patients for any clinical signs of thromboembolism by physical examination.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00056550


Locations
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United States, Georgia
Marietta, Georgia, United States
United States, South Carolina
Charleston, South Carolina, United States
France
Paris, France
Toulouse, France
Germany
Berlin, Germany
Hannover, Germany
Mannheim, Germany
Italy
Milan, Italy
Sweden
Stockholm, Sweden
United Kingdom
Bristol, United Kingdom
Manchester, United Kingdom
Sponsors and Collaborators
rEVO Biologics
Investigators
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Principal Investigator: Cambell Tait, MD Royal Infirmary Glaskow
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: rEVO Biologics
ClinicalTrials.gov Identifier: NCT00056550    
Other Study ID Numbers: GTC AT III 01002
First Posted: March 18, 2003    Key Record Dates
Results First Posted: October 16, 2012
Last Update Posted: October 16, 2012
Last Verified: August 2012
Keywords provided by rEVO Biologics:
Antithrombin Deficiency, Congenital
Antithrombin III Deficiency
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Antithrombin III Deficiency
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Blood Protein Disorders
 Thrombophilia
Genetic Diseases, Inborn
Antithrombins
Antithrombin III
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants