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)

September 17, 2012 updated by: rEVO Biologics

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • 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
  • United States
    • Georgia
      • Marietta, Georgia, United States
    • South Carolina
      • Charleston, South Carolina, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • ATryn

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, last day of dosing and day 7 (+ or - 1 day)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days after last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

rEVO Biologics

Investigators

  • Principal Investigator: Cambell Tait, MD, Royal Infirmary Glaskow

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (ACTUAL)

February 1, 2004

Study Completion (ACTUAL)

February 1, 2004

Study Registration Dates

First Submitted

March 17, 2003

First Submitted That Met QC Criteria

March 17, 2003

First Posted (ESTIMATE)

March 18, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

October 16, 2012

Last Update Submitted That Met QC Criteria

September 17, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GTC AT III 01002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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