Trial Outcomes & Findings for Recombinant Human Antithrombin (rhAT) in Patients With Hereditary Antithrombin Deficiency Undergoing Surgery or Delivery (NCT NCT00110513)

Last Updated: 2012-08-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

18 participants

Primary outcome timeframe

During treatment and follow up period of 7 days

Results posted on

2012-08-17

Participant Flow

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.

Eighteen patients were treated with recombinant human antithrombin (rhAT) and analyzed for safety.

Participant milestones

Participant milestones
Measure	Recombinant Human Antithrombin (rhAT) Infusion 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 Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Recombinant Human Antithrombin (rhAT) Infusion n=18 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	37.2 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment France	3 participants n=5 Participants
Region of Enrollment Canada	2 participants n=5 Participants
Region of Enrollment Australia	1 participants n=5 Participants
Region of Enrollment Germany	1 participants n=5 Participants
Region of Enrollment United Kingdom	8 participants n=5 Participants
Region of Enrollment Italy	1 participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants
Prior history of thromboembolism	18 Participants n=5 Participants
Antithrombin (AT) activity level <60%	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: During treatment and follow up period of 7 days

Population: Intent to treat population

Outcome measures

Outcome measures
Measure	Recombinant Human Antithrombin (rhAT) Infusion n=18 Participants 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.
Incidence of Thromboembolic Events Acute Deep Venous Thrombosis (DVT) and/or Thromboembolic Events Other Than Acute Deep Venous Thrombosis (DVT)	0 Participants

Adverse Events

Recombinant Human Antithrombin (rhAT) Infusion

Serious events: 5 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Recombinant Human Antithrombin (rhAT) Infusion n=18 participants at risk 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.
Musculoskeletal and connective tissue disorders Haemarthrosis	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Vascular disorders Haematoma	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Infections and infestations Enterobacter Sepsis	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Gastrointestinal disorders Intra-Abdominal	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Vascular disorders DVT	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Investigations Hemoglobin decreased	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.

Other adverse events

Other adverse events
Measure	Recombinant Human Antithrombin (rhAT) Infusion n=18 participants at risk 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.
Blood and lymphatic system disorders Anemia	16.7% 3/18 • Number of events 3 • Until 28 days after end of treatment.
Gastrointestinal disorders Vomiting	16.7% 3/18 • Number of events 3 • Until 28 days after end of treatment.
Nervous system disorders Headache	11.1% 2/18 • Number of events 5 • Until 28 days after end of treatment.
General disorders Non-Cardiac Chest Pain	11.1% 2/18 • Number of events 2 • Until 28 days after end of treatment.
General disorders Oedema Peripheral	11.1% 2/18 • Number of events 2 • Until 28 days after end of treatment.
Infections and infestations Urinary Tract Infection	11.1% 2/18 • Number of events 2 • Until 28 days after end of treatment.
Injury, poisoning and procedural complications Post Procedural Hemmorhage	11.1% 2/18 • Number of events 2 • Until 28 days after end of treatment.
Nervous system disorders Syncope	11.1% 2/18 • Number of events 2 • Until 28 days after end of treatment.
Reproductive system and breast disorders Vaginal Laceration	16.7% 3/18 • Number of events 3 • Until 28 days after end of treatment.
Vascular disorders Haematoma	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Cardiac disorders Tachycardia	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Eye disorders Vision Blurred	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Gastrointestinal disorders Abdominal Distention	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Gastrointestinal disorders Abdominal Pain	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Gastrointestinal disorders Constipation	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Gastrointestinal disorders Dental Discomfort	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Gastrointestinal disorders Dyspepsia	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Gastrointestinal disorders Flatulence	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Gastrointestinal disorders Haemorrhoids	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
General disorders Feeling Hot	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Gastrointestinal disorders Injection Site Bruising	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Infections and infestations Gastroenteritis Viral	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Infections and infestations Wound Infection	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Injury, poisoning and procedural complications Incision Site Complication	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Injury, poisoning and procedural complications Procedural Pain	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Injury, poisoning and procedural complications Vascular Graft Occlusion	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Injury, poisoning and procedural complications Wound Complicaton	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Investigations C-Reactive Protein Increased	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Investigations Hepatic Enzyme Abnormal	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Metabolism and nutrition disorders Hypokalemia	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Musculoskeletal and connective tissue disorders Arthropathy	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Musculoskeletal and connective tissue disorders Muscle Spasms	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Pregnancy, puerperium and perinatal conditions Afterbirth Pain	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Psychiatric disorders Anxiety	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Renal and urinary disorders Hematuria	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Renal and urinary disorders Incontinence	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Reproductive system and breast disorders Nipple Pain	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Respiratory, thoracic and mediastinal disorders Crackles Lung	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Skin and subcutaneous tissue disorders Hyperhidrosis	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Skin and subcutaneous tissue disorders Rash	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.
Vascular disorders Lymphangitis	5.6% 1/18 • Number of events 1 • Until 28 days after end of treatment.

Additional Information

Denise Tilton, RN, MHA, Director Clinical Affairs

GTC Biotherapeutics

Phone: 508-370-5257

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place