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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.
Objectives :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recombinant Human Antithrombin (rhAT) infusion | Experimental | Loading and continuous infusion dose of rhAT to target and maintain an AT activity level > 80% and < 120% of normal. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Human Antithrombin (rhAT) | Biological | Biological/Vaccine: Recombinant human antithrombin(rhAT) Phase III clinical trial. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Local Assessment of Thromboembolism by Physical Examination. | The investigators evaluated patients for any clinical signs of thromboembolism by physical examination. | 30 days after last dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cambell Tait, MD | Royal Infirmary Glaskow | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marietta | Georgia | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24335249 | Derived | 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. |
| Label | URL |
|---|---|
| Additional information on hereditary antithrombin disease | View source |
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Fourteen hereditary antithrombin (AT) deficient patients were enrolled into the trial. The patients included surgical (N = 5) and delivery patients (N = 9) who were treated with recombinant human antithrombin (rhAT) replacement therapy.
GTC Biotherapeutics (GTC) established clinical trials sites in hospitals located in the United States and Europe. GTC provided an international clinical team to support site registration requirements once a patient was identified for treatment. The clinical trial started in December 2002 and completed in February 2004.
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| ID | Title | Description |
|---|---|---|
| FG000 | Recombinant Human Antithrombin (rhAT) Infusion | Following a baseline evaluation phase hereditary antithrombin(AT)deficient patients scheduled for surgery, cesarean section or vaginal delivery were planned to be treated prophylactically with recombinant human antithrombin (rhAT). Dosing with recombinant human antithrombin (rhAT) was individualized with an initial intravenous loading dose, followed by a continuous intravenous infusion dose, intended to target and maintain antithrombin (AT) activity levels > 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 were based on the results of AT activity level determinations performed prior to and during the treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Charleston |
| South Carolina |
| United States |
| Paris | France |
| Toulouse | France |
| Berlin | Germany |
| Hanover | Germany |
| Mannheim | Germany |
| Milan | Italy |
| Stockholm | Sweden |
| Bristol | United Kingdom |
| Manchester | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Recombinant Human Antithrombin (rhAT) Infusion | Following a baseline evaluation phase hereditary AT deficient patients(previously documented AT activity < or equal to 60% of normal)scheduled for surgery ,cesarean section or vaginal delivery were planned to be treated prophylactically with rhAT. Dosing with rhAT was to be individualized with an initial loading dose, followed by a continuous maintenance infusion dose, intended to increase and target antithrombin (AT) activity levels > 80% and < 120% of normal. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Prior history of venous thrombotic events | Inclusion criteria states that patients had to have congenital antithrombin (AT) deficiency with a personal or family history of venous thrombotic events. | Number | Participants |
| ||||||||||||||||||||||
| Antithrombin (AT) activity level < or equal to 60% | Inclusion criteria states that the patients must have a history of congenital antithrombin (AT) deficiency that includes two or more plasma AT activity levels < or equal to 60% of normal | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 14 patients who received at least 1 dose of rhAT were included in the Safety population. During the central review of the duplex ultrasound, 1 delivery patient was diagnosed with a DVT at baseline, and was not evaluable for efficacy, the patient was excluded from the PP population. | Posted | Number | participants | Baseline, last day of dosing and day 7 (+ or - 1 day) |
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| Secondary | Local Assessment of Thromboembolism by Physical Examination. | The investigators evaluated patients for any clinical signs of thromboembolism by physical examination. | 14 patients were included in the trial and treated with rhAT. | Posted | Number | Participants in study | 30 days after last dose |
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Adverse event data was collected for duration of study up to 90 days post study drug administration.
All 14 patients who received rhAT were evaluated for the occurrence of treatment-emergent AEs from the time of their initial bolus dose up to and including 30 days after administration of their last dose of rhAT and for the development of antibodies to rhAT out to 90 days following treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Recombinant Human Antithrombin (rhAT) Infusion | Following a baseline evaluation phase hereditary AT deficient patients(previously documented AT activity < or equal to 60% of normal)scheduled for surgery ,cesarean section or vaginal delivery were planned to be treated prophylactically with rhAT. Dosing with rhAT was to be individualized with an initial loading dose, followed by a continuous maintenance infusion dose, intended to increase and target antithrombin (AT) activity levels > 80% and < 120% of normal. | 6 | 14 | 8 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Thrombophlebitis Deep | Vascular disorders | MedDRA (6.1) | Systematic Assessment |
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| Hypotension | Cardiac disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Hemorrhage NOS | Blood and lymphatic system disorders | MedDRA (6.1) | Systematic Assessment |
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| Convulsions Grand Mal | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
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| Fracture Trauma | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | MedDRA (6.1) | Systematic Assessment |
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| Post-operative pain | General disorders | MedDRA (6.1) | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | MedDRA (6.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
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| Infection | General disorders | MedDRA (6.1) | Systematic Assessment |
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| Hematoma | Blood and lymphatic system disorders | MedDRA (6.1) | Systematic Assessment |
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| Fever | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Denise Tilton, RN, MHA, Director Clinical Development | GTC Biotherapeutics | 508-370-5257 | denise.tilton@gtc-bio.com |
| ID | Term |
|---|---|
| D020152 | Antithrombin III Deficiency |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001796 | Blood Protein Disorders |
| D019851 | Thrombophilia |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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