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
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.
1 other identifier
interventional
14
6 countries
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2002
Shorter than P25 for phase_3
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedFirst Submitted
Initial submission to the registry
March 17, 2003
CompletedFirst Posted
Study publicly available on registry
March 18, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2004
CompletedResults Posted
Study results publicly available
October 16, 2012
CompletedOctober 16, 2012
August 1, 2012
1.2 years
March 17, 2003
March 19, 2012
September 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Baseline, last day of dosing and day 7 (+ or - 1 day)
Secondary Outcomes (1)
Local Assessment of Thromboembolism by Physical Examination.
30 days after last dose
Study Arms (1)
Recombinant Human Antithrombin (rhAT) infusion
EXPERIMENTALLoading and continuous infusion dose of rhAT to target and maintain an AT activity level \> 80% and \< 120% of normal.
Interventions
Biological/Vaccine: Recombinant human antithrombin(rhAT) Phase III clinical trial.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- rEVO Biologicslead
Study Sites (11)
Unknown Facility
Marietta, Georgia, United States
Unknown Facility
Charleston, South Carolina, United States
Unknown Facility
Paris, France
Unknown Facility
Toulouse, France
Unknown Facility
Berlin, Germany
Unknown Facility
Hanover, Germany
Unknown Facility
Mannheim, Germany
Unknown Facility
Milan, Italy
Unknown Facility
Stockholm, Sweden
Unknown Facility
Bristol, United Kingdom
Unknown Facility
Manchester, United Kingdom
Related Publications (1)
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.
PMID: 24335249DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Denise Tilton, RN, MHA, Director Clinical Development
- Organization
- GTC Biotherapeutics
Study Officials
- PRINCIPAL INVESTIGATOR
Cambell Tait, MD
Royal Infirmary Glaskow
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2003
First Posted
March 18, 2003
Study Start
December 1, 2002
Primary Completion
February 1, 2004
Study Completion
February 1, 2004
Last Updated
October 16, 2012
Results First Posted
October 16, 2012
Record last verified: 2012-08