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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Recombinant Human Antithrombin (rhAT) in Patients With Hereditary Antithrombin Deficiency Undergoing Surgery or Delivery
Scientific 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
Secondary ID [1] 0 0
GTC AT HD 012-04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Antithrombin III Deficiency 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Blood 0 0 0 0
Clotting disorders

Study type
Description of intervention(s) / exposure
Other interventions - Recombinant human antithrombin (rhAT)

Experimental: Recombinant Human Antithrombin (rhAT) Infusion - Intravenous infusion of rhAT.

Other interventions: 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.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Incidence of Thromboembolic Events Acute Deep Venous Thrombosis (DVT) and/or Thromboembolic Events Other Than Acute Deep Venous Thrombosis (DVT) - 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.
Timepoint [1] 0 0
During treatment and follow up period of 7 days

Key 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.
Minimum age
18 Years
Maximum age
80 Years
Both males and females
Can healthy volunteers participate?
Key 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

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).

Study design
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- North Gosford
Recruitment postcode(s) [1] 0 0
- North Gosford
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Country [2] 0 0
United States of America
State/province [2] 0 0
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
State/province [4] 0 0
Country [5] 0 0
State/province [5] 0 0
Country [6] 0 0
State/province [6] 0 0
Country [7] 0 0
State/province [7] 0 0
Country [8] 0 0
State/province [8] 0 0
Country [9] 0 0
State/province [9] 0 0
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Country [11] 0 0
United Kingdom
State/province [11] 0 0
West Sussex
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Country [16] 0 0
United Kingdom
State/province [16] 0 0

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
rEVO Biologics

Ethics approval
Ethics application status

Brief summary
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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Robert C Tait, MD
Address 0 0
Glasgow Royal Infirmary
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications