Trial record 3 of 3 for:    "Congenital antithrombin deficiency"

Recombinant Human Antithrombin (rhAT) in Patients With Hereditary Antithrombin Deficiency Undergoing Surgery or Delivery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
rEVO Biologics
ClinicalTrials.gov Identifier:
NCT00110513
First received: May 10, 2005
Last updated: August 10, 2012
Last verified: August 2012
  Purpose

Patients with hereditary antithrombin deficiency are at increased risk of venous thrombosis and pulmonary embolism, particularly during certain high risk procedures. The trial focused on patients with confirmed hereditary antithrombin deficiency who were undergoing a surgical procedure or induced/spontaneous labor and delivery, and/or caesarean section. The study assessed the incidence of thromboembolic events following prophylactic intravenous administration of recombinant human antithrombin (rhAT) to patients with hereditary antithrombin (AT) deficiency in situations usually associated with a high risk for thromboembolic events.


Condition Intervention Phase
Antithrombin III Deficiency
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 Multicenter, Multinational Study to Assess the Safety and Efficacy of Antithrombin Alfa in Hereditary Antithrombin (AT) Deficient Patients in High-Risk Situations for Thrombosis

Resource links provided by NLM:


Further study details as provided by rEVO Biologics:

Primary Outcome Measures:
  • Incidence of Thromboembolic Events Acute Deep Venous Thrombosis (DVT) and/or Thromboembolic Events Other Than Acute Deep Venous Thrombosis (DVT) [ Time Frame: During treatment and follow up period of 7 days ] [ Designated as safety issue: No ]
    To assess the incidence of thromboembolic events acute deep venous thrombosis (DVT) and/or thromboembolic events other than acute deep venous thrombosis (DVT) by clinical signs and symptoms of venous thromboembolism (VTE), confirmed by diagnostic assessments.


Enrollment: 18
Study Start Date: April 2005
Study Completion Date: July 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Recombinant Human Antithrombin (rhAT) Infusion
Intravenous infusion of rhAT.
Biological: Recombinant human antithrombin (rhAT)
Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient will receive an initial intravenous loading dose followed by a continuous intravenous infusion of recombinant human antithrombin (rhAT) that will target and maintain an AT activity that is > 80% and < 120% of normal. The dosing objective for all study patients is maintenance of the AT activity at > 80% and < 120% of normal during the high-risk period for thromboembolic events. Dosing and dose adjustments will be based on the results of AT activity determinations performed prior to and during treatment.
Other Name: Recombinant human antithrombin (Tradename: ATryn)

Detailed Description:

GTC Biotherapeutics established clinical trial sites in Europe, Canada, Australia, Austria and Canada. GTC Biotherapeutics provided an international clinical team to support site registration requirements once a patient was identified for treatment. GTC Biotherapeutics also provided consultation to help evaluate patient eligibility.

In September 2006, GTC Biotherapeutics modified exclusion criteria 1 (below) to allow for the participation of previously excluded patients with the hereditary thrombophilic disorders Factor V Leiden and prothrombin gene mutation (G20210A).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have hereditary antithrombin deficiency (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%.
  3. Be scheduled to have an elective procedure(s) known to be associated with a high risk for occurrence for 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 exceeding 80 years of age.
  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.

In addition, hospitalized pregnant HD patients in active labor and eligible HD patients previously treated with rhAT were allowed entry into the study.

Exclusion Criteria:

  1. Patients who have a diagnosis of another hereditary thrombophilic disorder (e.g. activated protein C(APC) resistance/Factor V Leiden, Protein S or C deficiency, prothrombin gene mutation (G20210A), 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.
  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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110513

Locations
United States, Connecticut
New Haven, Connecticut, United States
United States, Missouri
St Louis, Missouri, United States
United States, New York
New York, New York, United States
Australia
North Gosford, Australia
Austria
Vienna, Austria
Canada, Ontario
Ottawa, Ontario, Canada
Canada
Vancouver, Canada
France
Montpellier, France
Germany
Berlin, Germany
Italy
Alessandria, Italy
United Kingdom
Exeter, Devon, United Kingdom
Chichester, West Sussex, United Kingdom
Cambridge, United Kingdom
Glasgow, United Kingdom
London, United Kingdom
Nottingham, United Kingdom
Plymouth, United Kingdom
Sponsors and Collaborators
rEVO Biologics
Investigators
Principal Investigator: Robert C Tait, MD Glasgow Royal Infirmary
  More Information

No publications provided

Responsible Party: rEVO Biologics
ClinicalTrials.gov Identifier: NCT00110513     History of Changes
Other Study ID Numbers: GTC AT HD 012-04
Study First Received: May 10, 2005
Results First Received: March 19, 2012
Last Updated: August 10, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council
Austria: Ethikkommission
Austria: Federal Ministry for Health and Women
Canada: Ethics Review Committee
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee
Germany: Ethics Commission
Germany: Paul-Ehrlich-Institut
Italy: Ethics Committee
Italy: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by rEVO Biologics:
Antithrombin Deficiency, Congenital or Hereditary
Antithrombin III Deficiency
ATIII
Hereditary Antithrombin Deficiency (HD)

Additional relevant MeSH terms:
Antithrombin III Deficiency
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 July 24, 2014