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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)

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ClinicalTrials.gov Identifier: NCT00056550
Recruitment Status : Completed
First Posted : March 18, 2003
Results First Posted : October 16, 2012
Last Update Posted : October 16, 2012
Sponsor:
Information provided by (Responsible Party):
rEVO Biologics

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Antithrombin Deficiency, Congenital
Intervention Biological: Recombinant Human Antithrombin (rhAT)
Enrollment 14
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Recombinant Human Antithrombin (rhAT) Infusion
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 14
Completed 14
Not Completed 0
Arm/Group Title Recombinant Human Antithrombin (rhAT) Infusion
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
0
   0.0%
Between 18 and 65 years
13
  92.9%
>=65 years
1
   7.1%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
36.7  (13.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
12
  85.7%
Male
2
  14.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
13
  92.9%
More than one race
0
   0.0%
Unknown or Not Reported
1
   7.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants
Europe 12
United States 2
Prior history of venous thrombotic events   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants
14
[1]
Measure Description: Inclusion criteria states that patients had to have congenital antithrombin (AT) deficiency with a personal or family history of venous thrombotic events.
Antithrombin (AT) activity level < or equal to 60%   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants
14
[1]
Measure Description: 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
1.Primary Outcome
Title Incidence of Thromboembolic Events Acute Deep Venous Thrombosis (DVT) and/or Thromboembolic Events Other Than Acute Deep Vein Thrombosis (DVT).
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Recombinant Human Antithombin (rhAT) Infusion
Hide Arm/Group Description:
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 rhAT was to be individualized with an initial loading dose, followed by a continuous maintenance 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 will be based on the results of AT activity determinations performed prior to and during treatment.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: participants
1
2.Secondary Outcome
Title Local Assessment of Thromboembolism by Physical Examination.
Hide Description The investigators evaluated patients for any clinical signs of thromboembolism by physical examination.
Time Frame 30 days after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
14 patients were included in the trial and treated with rhAT.
Arm/Group Title Recombinant Human Antithrombin (rhAT) Infusion
Hide Arm/Group Description:
Following a baseline evaluation phase hereditary AT deficient patients 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 target and maintain antithrombin (AT) activity levels > 80% and < 120% of normal.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: Participants in study
0
Time Frame Adverse event data was collected for duration of study up to 90 days post study drug administration.
Adverse Event Reporting Description 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.
 
Arm/Group Title Recombinant Human Antithrombin (rhAT) Infusion
Hide Arm/Group Description 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.
All-Cause Mortality
Recombinant Human Antithrombin (rhAT) Infusion
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Recombinant Human Antithrombin (rhAT) Infusion
Affected / at Risk (%) # Events
Total   6/14 (42.86%)    
Blood and lymphatic system disorders   
Hemorrhage NOS  1  1/14 (7.14%)  1
Cardiac disorders   
Hypotension  1  1/14 (7.14%)  1
General disorders   
Fever  1  1/14 (7.14%)  1
Musculoskeletal and connective tissue disorders   
Fracture Trauma  1  1/14 (7.14%)  1
Nervous system disorders   
Convulsions Grand Mal  1  1/14 (7.14%)  1
Vascular disorders   
Thrombophlebitis Deep  1  1/14 (7.14%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (6.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Recombinant Human Antithrombin (rhAT) Infusion
Affected / at Risk (%) # Events
Total   8/14 (57.14%)    
Blood and lymphatic system disorders   
Anemia  1  1/14 (7.14%)  4
Hematoma  1  1/14 (7.14%)  3
Cardiac disorders   
Hypotension  1  1/14 (7.14%)  5
Gastrointestinal disorders   
Nausea  1  1/14 (7.14%)  2
Vomiting  1  1/14 (7.14%)  2
General disorders   
Post-operative pain  1  1/14 (7.14%)  4
Infection  1  1/14 (7.14%)  2
Infections and infestations   
Fever  1  1/14 (7.14%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (6.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Denise Tilton, RN, MHA, Director Clinical Development
Organization: GTC Biotherapeutics
Phone: 508-370-5257
EMail: denise.tilton@gtc-bio.com
Layout table for additonal information
Responsible Party: rEVO Biologics
ClinicalTrials.gov Identifier: NCT00056550     History of Changes
Other Study ID Numbers: GTC AT III 01002
First Submitted: March 17, 2003
First Posted: March 18, 2003
Results First Submitted: March 19, 2012
Results First Posted: October 16, 2012
Last Update Posted: October 16, 2012