Prophylaxis of Venous Thromboembolic Events Clinical Trial
Official title:
Single Intravenous Administration of TB-402 for the Prophylaxis of Venous Thromboembolic Events (VTE) After Total Hip Replacement Surgery: A Phase 2b, Multicentre, Randomised, Active-Controlled, Double Blind, Double Dummy, Parallel Group Study
The purpose of this study is to evaluate the safety and efficacy of two doses of TB-402 administered as a single intravenous infusion for the prevention of VTE in subjects undergoing total hip replacement surgery.
| Status | Completed |
| Enrollment | 632 |
| Est. completion date | May 2012 |
| Est. primary completion date | December 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Male or female subjects aged = 18 years. 2. Written informed consent. 3. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures Exclusion Criteria: 1. Pregnancy at the time of screening. 2. Indication for anticoagulation other than post-operative thromboprophylaxis. 3. Active bleeding or high risk of bleeding. 4. Anticipated continued use of neuraxial catheter after surgery. 5. Clinical laboratory findings at screening of thrombocytopenia or prolonged aPTT or PT. 6. Uncontrolled hypertension. 7. Impaired liver function (transaminase >3 X ULN) or history of hepatic insufficiency. 8. Creatinine clearance <30 mL/min. 9. Antiplatelet agents other than low dose aspirin (< 200mg). 10. The use of intermittent pneumatic compression. 11. Known hypersensitivity to contrast media or rivaroxaban. 12. Known drug or alcohol abuse. 13. Active malignant disease or current cytostatic treatment. 14. Stroke within the previous month. 15. Participation in an investigational drug study within the past 30 days or previous participation in this study. 16. Any condition that in the opinion of the investigator would put the subject at increased risk from participating in the study or expected inability to comply with the protocol. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Austria | KRANKENHAUS DES BARMHER.SCHW.Linz | Linz | |
| Austria | Klinikum Wels-Grieskirchen GmbH | Wels | |
| Austria | AKH Wien | Wien | |
| Austria | Orthopädisches Spital Speising | Wien | |
| Belgium | ZNA Antwerpen Locatie Middelheim | Antwerpen | |
| Bulgaria | SHAT of orthopedics, traumatology and surgery "Sv. Pantaleimon " - Pleven Department of Orthopaedics and Traumatology | Pleven | |
| Bulgaria | Department of Orthopedics, UMHAT "Sv. Georgi" | Plovdiv | |
| Bulgaria | MHAT Rousse, Department of Orthopaedics | Rousse | |
| Bulgaria | UMHAT "St Anna" AD,Clinic of Orthopaedics and Traumatology | Sofia | |
| Bulgaria | UMHAT 'Tsaritsa Joanna' | Sofia | |
| Hungary | Pándy Kálmán Kórház | Gyula | |
| Hungary | Bács-Kiskun Megyei Önkormányzat Kórháza, Szegedi Tudományegyetem Általános Orvostudományi Karháza | Kecskemét | |
| Hungary | Tolna Megyei Önkormányzat Balassa János Kórháza | Szekszárd | |
| Latvia | Traumatology and Orthopedics Clinic "Adazi", LTD | Adazi | |
| Latvia | Ltd "Liepajas regionala slimnica" | Liepaja | |
| Latvia | Riga 2nd Hospital | Riga | |
| Latvia | Ltd "Vidzemes slimnica" | Valmiera | |
| Netherlands | Diaconessenhuis Leiden | Leiden | |
| Poland | Klinika Orthopedii I Traumatologii | Bialystok | |
| Poland | Wojewódzkie Centrum Ortopedii i Rehabilitacji Narzadu Ruchu im. dr Z. Radlinskiego w Lodzi | Lódz | |
| Poland | NZOZ Szpital w Puszczykowie | Puszczykowo | |
| Poland | Medical University of warsaw, Dept of Orthopaedics | Warsaw | |
| Poland | Klinika Ortopedii, WIM | Warszawa | |
| Russian Federation | Municipal Healthcare Institution "City Clinical Hospital No. 3" | Chelabinsk | |
| Russian Federation | Municipal Healthcare Medical Institution "City Clinical Hospital No. 4" | Orenburg | |
| Russian Federation | Federal State Healthcare Institution: Clinical Hospital #122 named after L.G. Sokolov under the Federal Medical-Biological Agency of Russia | Saint-Petersburg | |
| Russian Federation | Saint Petersburg State Healthcare Institution "City Aleksandrovskaya Hospital" | Saint-Petersburg | |
| Russian Federation | Saint Petersburg State Healthcare Institution "Municipal Multi-Speciality Hospital No. 2" | Saint-Petersburg | |
| Russian Federation | State Healthcare Institution "Samara Regional Clinical Hospital n.a. M.I. Kalinin" | Samara | |
| Russian Federation | Municipal Healthcare Institution "Clinical Hospital of Emergency Care n.a. N.V. Soloviov" | Yaroslavl | |
| Ukraine | Public Entity "Regional Hospital - Center of Emergency Medical Care and Disaster Medicine" of Cherkasy Regional Council, Department of orthopedy and traumatology | Cherkassy | |
| Ukraine | Ivano-Frank?vsk Regional Clinical Hospital MoH Ukraine, Department of ortopedics and traumatology. Department of traumatology, ortopedics and military/emergency surgery of Ivano-Frank?vsk National Medical University | Ivano-Frankivsk | |
| Ukraine | SE "Sytenko Institute of Spine and Joint Pathology, AMS Ukraine", department of orthopedic arthrology and endoprosthesis replacement | Kharkiv | |
| Ukraine | Public Entity of Kyiv Regional council "Kyiv Regional Clinical Hospital", Ortopedy and traumatology center of Public Entity of Kyiv Regional council "Kyiv Regional Clinical Hospital" | Kyiv | |
| Ukraine | Public Establishment "Odessa Regional Clinical Hospital", Department of Orthopedics and Traumatology. | Odessa | |
| Ukraine | Public Establishment 'City Hospital #9', orthopedy and traumatology department | Sevastopol |
| Lead Sponsor | Collaborator |
|---|---|
| ThromboGenics | BioInvent International AB |
Austria, Belgium, Bulgaria, Hungary, Latvia, Netherlands, Poland, Russian Federation, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Composite of asymptomatic DVT as detected by bilateral venography and symptomatic VTE, i.e. DVT or fatal or non-fatal PE | Randomisation to post-operative day 35 | No | |
| Secondary | Incidents of major VTE | Randomisation to Post-Operative day 35 | No | |
| Secondary | Incidents of total DVT | Randomisation to Post-Operative day 35 | No | |
| Secondary | Incidents of proximal/distal DVT | Randomisation to Post-Operative day 35 | No | |
| Secondary | Incidents of pulmonary embolism | Randomisation to Post-Operative day 35 | No | |
| Secondary | Incidents of VTE-related death | Randomisation to Post-Operative day 35 | No | |
| Secondary | Incidents of Major VTE | Randomisation to Post-Operative day 70 | No |