Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Recombinant Human Antithrombin (rhAT) in Patients With Hereditary Antithrombin Deficiency Undergoing Surgery or Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00110513
Recruitment Status : Completed
First Posted : May 11, 2005
Results First Posted : May 11, 2012
Last Update Posted : August 17, 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 III Deficiency
Intervention Biological: Recombinant human antithrombin (rhAT)
Enrollment 18
Recruitment Details The study population included non pregnant patients who were scheduled for surgery and pregnant patients who were scheduled for caesarean section or delivery induction or were hospitalized in active labor.
Pre-assignment Details Eighteen patients were treated with recombinant human antithrombin (rhAT) and analyzed for safety.
Arm/Group Title Recombinant Human Antithrombin (rhAT) Infusion
Hide Arm/Group Description Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient received an initial intravenous loading dose of recombinant human antithrombin (rhAT)followed by a continuous intravenous infusion dose of recombinant human antithrombin (rhAT) to maintain an antithrombin (AT) activity level of >80% and <120% of normal.
Period Title: Overall Study
Started 18
Completed 18
Not Completed 0
Arm/Group Title Recombinant Human Antithrombin (rhAT) Infusion
Hide Arm/Group Description Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient received an initial intravenous loading dose of recombinant human antithrombin (rhAT)followed by a continuous intravenous infusion dose of recombinant human antithrombin (rhAT) to maintain an antithrombin (AT) activity level of >80% and <120% of normal.
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
0
   0.0%
Between 18 and 65 years
18
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
37.2  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
14
  77.8%
Male
4
  22.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants
France 3
Canada 2
Australia 1
Germany 1
United Kingdom 8
Italy 1
United States 2
Prior history of thromboembolism  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants
18
Antithrombin (AT) activity level <60%  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants
18
1.Primary Outcome
Title Incidence of Thromboembolic Events Acute Deep Venous Thrombosis (DVT) and/or Thromboembolic Events Other Than Acute Deep Venous Thrombosis (DVT)
Hide Description 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.
Time Frame During treatment and follow up period of 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title Recombinant Human Antithrombin (rhAT) Infusion
Hide Arm/Group Description:
Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient received an initial intravenous loading dose of recombinant human antithrombin (rhAT)followed by a continuous intravenous infusion dose of recombinant human antithrombin (rhAT) to maintain an antithrombin (AT) activity level >80% and <120% of normal.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: Participants
0
Time Frame Until 28 days after end of treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Recombinant Human Antithrombin (rhAT) Infusion
Hide Arm/Group Description Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient received an initial intravenous loading dose of recombinant human antithrombin (rhAT)followed by a continuous intravenous infusion dose of recombinant human antithrombin (rhAT) to maintain an antithrombin (AT) activity level of >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   5/18 (27.78%)    
Gastrointestinal disorders   
Intra-Abdominal  1  1/18 (5.56%)  1
Infections and infestations   
Enterobacter Sepsis  1  1/18 (5.56%)  1
Investigations   
Hemoglobin decreased  1  1/18 (5.56%)  1
Musculoskeletal and connective tissue disorders   
Haemarthrosis  1  1/18 (5.56%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary Embolism  1 [1]  1/18 (5.56%)  1
Vascular disorders   
Haematoma  1  1/18 (5.56%)  1
DVT  1 [2]  1/18 (5.56%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (6.1)
[1]
The patient received study drug from 21 November 2005 through 25 November 2005. On 09 December 2005, the patient experienced bilateral pulmonary embolism, which was reported as an important medical event and described as severe.
[2]
An ultrasound of the lower extremities performed on post-operative day 14, revealed an occlusive thrombus in the right saphenous vein which was noted on previous ultrasound performed and had progressed to the popliteal vein. Reported as not related.
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   16/18 (88.89%)    
Blood and lymphatic system disorders   
Anemia  1  3/18 (16.67%)  3
Cardiac disorders   
Tachycardia  1  1/18 (5.56%)  1
Eye disorders   
Vision Blurred  1  1/18 (5.56%)  1
Gastrointestinal disorders   
Vomiting  1  3/18 (16.67%)  3
Abdominal Distention  1  1/18 (5.56%)  1
Abdominal Pain  1  1/18 (5.56%)  1
Constipation  1  1/18 (5.56%)  1
Dental Discomfort  1  1/18 (5.56%)  1
Dyspepsia  1  1/18 (5.56%)  1
Flatulence  1  1/18 (5.56%)  1
Haemorrhoids  1  1/18 (5.56%)  1
Injection Site Bruising  1  1/18 (5.56%)  1
General disorders   
Non-Cardiac Chest Pain  1  2/18 (11.11%)  2
Oedema Peripheral  1  2/18 (11.11%)  2
Feeling Hot  1  1/18 (5.56%)  1
Infections and infestations   
Urinary Tract Infection  1  2/18 (11.11%)  2
Gastroenteritis Viral  1  1/18 (5.56%)  1
Wound Infection  1  1/18 (5.56%)  1
Injury, poisoning and procedural complications   
Post Procedural Hemmorhage  1  2/18 (11.11%)  2
Incision Site Complication  1  1/18 (5.56%)  1
Procedural Pain  1  1/18 (5.56%)  1
Vascular Graft Occlusion  1  1/18 (5.56%)  1
Wound Complicaton  1  1/18 (5.56%)  1
Investigations   
C-Reactive Protein Increased  1  1/18 (5.56%)  1
Hepatic Enzyme Abnormal  1  1/18 (5.56%)  1
Metabolism and nutrition disorders   
Hypokalemia  1  1/18 (5.56%)  1
Musculoskeletal and connective tissue disorders   
Arthropathy  1  1/18 (5.56%)  1
Muscle Spasms  1  1/18 (5.56%)  1
Nervous system disorders   
Headache  1  2/18 (11.11%)  5
Syncope  1  2/18 (11.11%)  2
Pregnancy, puerperium and perinatal conditions   
Afterbirth Pain  1  1/18 (5.56%)  1
Psychiatric disorders   
Anxiety  1  1/18 (5.56%)  1
Renal and urinary disorders   
Hematuria  1  1/18 (5.56%)  1
Incontinence  1  1/18 (5.56%)  1
Reproductive system and breast disorders   
Vaginal Laceration  1  3/18 (16.67%)  3
Nipple Pain  1  1/18 (5.56%)  1
Respiratory, thoracic and mediastinal disorders   
Crackles Lung  1  1/18 (5.56%)  1
Dyspnea  1  1/18 (5.56%)  1
Epistaxis  1  1/18 (5.56%)  1
Skin and subcutaneous tissue disorders   
Hyperhidrosis  1  1/18 (5.56%)  1
Rash  1  1/18 (5.56%)  1
Vascular disorders   
Haematoma  1  1/18 (5.56%)  1
Lymphangitis  1  1/18 (5.56%)  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 Affairs
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: NCT00110513     History of Changes
Other Study ID Numbers: GTC AT HD 012-04
First Submitted: May 10, 2005
First Posted: May 11, 2005
Results First Submitted: March 19, 2012
Results First Posted: May 11, 2012
Last Update Posted: August 17, 2012