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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.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GTC Biotherapeutics
ClinicalTrials.gov Identifier:
NCT00056550
First received: March 17, 2003
Last updated: September 17, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Antithrombin Deficiency, Congenital
 Biological: Recombinant Human Antithrombin (rhAT)
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GTC Biotherapeutics:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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:
  • Local Assessment of Thromboembolism by Physical Examination. [ Time Frame: 30 days after last dose ] [ Designated as safety issue: No ]
    The investigators evaluated patients for any clinical signs of thromboembolism by physical examination.


Enrollment: 14
Study Start Date: December 2002
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Names:
  • ATryn
  • Recombinant human antithrombin (rhAT)

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.
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00056550

Locations
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
GTC Biotherapeutics
Investigators
Principal Investigator: Cambell Tait, MD Royal Infirmary Glaskow
  More Information

No publications provided

Responsible Party: GTC Biotherapeutics
ClinicalTrials.gov Identifier: NCT00056550     History of Changes
Other Study ID Numbers: GTC AT III 01002
Study First Received: March 17, 2003
Results First Received: March 19, 2012
Last Updated: September 17, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
France: Institutional Ethical Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Ethics Commission
Germany: Paul-Ehrlich-Institut
Italy: Ethics Committee
Italy: Ministry of Health
Sweden: Institutional Review Board
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by GTC Biotherapeutics:
Antithrombin Deficiency, Congenital
Antithrombin III Deficiency

Additional relevant MeSH terms:
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
Antithrombin Proteins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013