Venous thrombolic events MedDRA version: 9.1 Level: LLT Classification code 10049909 Term: Venous thromboembolism prophylaxis
Conditions
Interventions
Product Name: TB-402
Product Code: TB-402
Pharmaceutical Form: Solution for infusion
Other descriptive name: TB-402
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentr
Sponsors
ThromboGenics N.V
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged > 18 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Body weight 100 kg 2. Patients undergoing a hemiarthroplasty, surface repair or revisionary surgery of the knee 3. Confirmed symptomatic deep vein thrombosis or pulmonary embolism within the past year 4. Anticipated use of indwelling intrathecal or epidural catheter for more than 4 h after surgery or during the entire study 5. Uncontrolled hypertension (SBP>160 mm Hg or DBP > 100 mm Hg) 6. History of intracranial or intraocular bleeding. History of gastrointestinal and/or endoscopically verified ulcer disease within the past year 7. Patients at increased risk of bleeding because of personal history of increased bleeding tendency or any other condition that in the opinion of the investigator increases risk of bleeding (e.g. documented angiodysplasia, recurrent gastrointestinal ulcer) 8. Clinical laboratory evidence at screening of anemia (haemoglobin level 3 X ULN or bilirubin > 1.5 ULN) or history of hepatic insufficiency 15. Known drug or alcohol abuse 16. Active malignant disease or current cytostatic treatment 17. Participation in an investigational drug study within the past 30 days or previous participation in this trial 18. Any condition which in the opinion of the investigator would put the patient at increased risk from participating in the study 19. Scheduled invasive or surgical procedure within 8 weeks after surgery 20. Brain, spinal, or ophthalmological invasive surgery within the previous 3 months before enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to evaluate the safety and efficacy of a single administration of TB-402 for the prevention of VTE in patients undergoing knee replacement surgery.;Secondary Objective: ;Primary end point(s): The primary efficacy endpoint is; Composite of the occurrence of asymptomatic DVT as detected by bilateral venography and symptomatic VTE, i.e. DVT or fatal or non-fatal PE, up to hospital discharge at D 7 – 11. The following definitions are applied to assess suspected episodes of PE/DVT: Clinically suspected DVT with one of the following findings: • an intraluminal filling defect on venography or , an extension of an intraluminal filling defect, or a new intraluminal filling defect or an extension of non-visualization of veins in the presence of a sudden cut-off on venography, or • abnormal compression ultrasound (CUS) Clinically suspected PE with one of the following findings: • an intraluminal filling defect in segmental or more proximal branches on sCT (spiral CT) • an intraluminal filling defect or an extension of an existing defect or a new sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram, • a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scintigraphy • inconclusive sCT, pulmonary angiography or lung scintigraphy with demonstration of DVT in the lower extremities by compression ultrasound or venography. Fatal PE • PE based on objective diagnostic testing, autopsy, or • death which cannot be attributed to a documented cause and for which PE/DVT cannot be ruled out (unexplained death). The primary safety endpoint is: The occurrence of total bleeding defined as major and/or clinically relevant non-major bleeding events, from randomisation until the end of the study. Major bleeding is defined as acute clinically overt bleeding: • associated with a fall in hemoglobin of 2 g/dL (i.e 1.25 mmol/L) or more, or • l | — |
Countries
Bulgaria, Latvia
Outcome results
None listed