Single Intravenous Administration of TB-402 for the Prophylaxis of Venous hromboembolic Events (VTE) After Total Knee Replacement Surgery: A Dose-Escalating, Multicenter, Randomised, Active-Controlled Open Label Study

• Conditions: MedDRA version: 9.1Level: LLTClassification code 10049909Term: Venous thromboembolism prophylaxis; Venous thrombolic events

• Registration Number: EUCTR2008-004539-39-LV
• Lead Sponsor: ThromboGenics N.V

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Male or female patients aged > 18 and < 80 years old
2. Female patients should be post menopausal
3. Patients undergoing primary elective total knee replacement surgery
4. Written informed consent obtained from the patient (or legally acceptable
representative) prior to inclusion in the study
5. Willing and able to comply with scheduled visits, treatment plan, laboratory tests
and other study procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Body weight < 50 kg or > 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 < 10.0
g/dL) or thrombocytopenia (platelet count < 100X103/µL) or prolonged activated
partial thromboplastin time (APTT) or prothrombin time (PT) as per local lab
ranges
9. Excessive peroperative bleeding and/or active significant postoperative wound
bleeding as per the investigator’s judgement
10. Antiplatelet agents other than low dose aspirin < 160mg. The use of
antithrombotic therapy within 7 days before surgery except for a
thromboprophylactic dose of LMWH or unfractionated heparin. The use of
intermittent pneumatic compression.
11. Patients who require long-term anticoagulant treatment for a comorbid
condition.
12. History of significant adverse reaction (e.g. Heparin- or LMWH- induced
thrombocytopenia) to an anticoagulant
13. Creatinin clearance <30 mL/min, hypersensitivity to contrast media,
hypersensitivity to enoxaparin sodium
14. Active hepatic disease (defined as transaminase >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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified