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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)

Primary Purpose

Antithrombin Deficiency, Congenital

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Recombinant Human Antithrombin (rhAT)
Sponsored by
rEVO Biologics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Antithrombin Deficiency, Congenital focused on measuring Antithrombin Deficiency, Congenital, Antithrombin III Deficiency

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Recombinant Human Antithrombin (rhAT) infusion

Arm Description

Loading and continuous infusion dose of rhAT to target and maintain an AT activity level > 80% and < 120% of normal.

Outcomes

Primary Outcome Measures

Incidence of Thromboembolic Events Acute Deep Venous Thrombosis (DVT) and/or Thromboembolic Events Other Than Acute Deep Vein Thrombosis (DVT).
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.
The investigators evaluated patients for any clinical signs of thromboembolism by physical examination.

Full Information

First Posted
March 17, 2003
Last Updated
September 17, 2012
Sponsor
rEVO Biologics
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1. Study Identification

Unique Protocol Identification Number
NCT00056550
Brief Title
Assess Incidence of Deep Vein Thrombosis(DVT)Following Administration of Recombinant Human Antithrombin (rhAT) to Hereditary Antithrombin(AT) Deficient Patients in High Risk Situations.
Acronym
rhAT
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 Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
February 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
rEVO Biologics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antithrombin Deficiency, Congenital
Keywords
Antithrombin Deficiency, Congenital, Antithrombin III Deficiency

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Recombinant Human Antithrombin (rhAT) infusion
Arm Type
Experimental
Arm Description
Loading and continuous infusion dose of rhAT to target and maintain an AT activity level > 80% and < 120% of normal.
Intervention Type
Biological
Intervention Name(s)
Recombinant Human Antithrombin (rhAT)
Other Intervention Name(s)
ATryn
Intervention Description
Biological/Vaccine: Recombinant human antithrombin(rhAT) Phase III clinical trial.
Primary Outcome Measure Information:
Title
Incidence of Thromboembolic Events Acute Deep Venous Thrombosis (DVT) and/or Thromboembolic Events Other Than Acute Deep Vein Thrombosis (DVT).
Description
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).
Time Frame
Baseline, last day of dosing and day 7 (+ or - 1 day)
Secondary Outcome Measure Information:
Title
Local Assessment of Thromboembolism by Physical Examination.
Description
The investigators evaluated patients for any clinical signs of thromboembolism by physical examination.
Time Frame
30 days after last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cambell Tait, MD
Organizational Affiliation
Royal Infirmary Glaskow
Official's Role
Principal Investigator
Facility Information:
City
Marietta
State/Province
Georgia
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Paris
Country
France
City
Toulouse
Country
France
City
Berlin
Country
Germany
City
Hannover
Country
Germany
City
Mannheim
Country
Germany
City
Milan
Country
Italy
City
Stockholm
Country
Sweden
City
Bristol
Country
United Kingdom
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24335249
Citation
DeJongh J, Frieling J, Lowry S, Drenth HJ. Pharmacokinetics of recombinant human antithrombin in delivery and surgery patients with hereditary antithrombin deficiency. Clin Appl Thromb Hemost. 2014 May;20(4):355-64. doi: 10.1177/1076029613516188. Epub 2013 Dec 11.
Results Reference
derived

Learn more about this trial

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

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