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NCT Number: NCT00056550

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

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.

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Key information

Conditions

Antithrombin Deficiency, Congenital Antithrombin III Deficiency Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Blood Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Thrombophilia

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Paris, France

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About this study

Objectives :

  • Assess the safety of recombinant antithrombin (rhAT) in hereditary antithrombin (AT) deficient patients.
  • 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.
  • Clinically assess and determine the relevance of thromboembolic events other than acute DVT to rhAT administration.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Recombinant Human Antithrombin (rhAT)

Biological

Biological/Vaccine: Recombinant human antithrombin(rhAT) Phase III clinical trial.

Other names: ATryn

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

rEVO Biologics

Industry

Registry information

Official study 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.

Acronym: rhAT

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Mar 18, 2003
Registry last updated
Oct 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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