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| Name | Class |
|---|---|
| BioInvent International AB | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 25mg TB-402 | Experimental |
| |
| 50mg TB-402 | Experimental |
| |
| 10mg QD Rivaroxaban | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TB-402 | Drug | Administered intravenously over 10 minutes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidents of major VTE | Randomisation to Post-Operative day 35 | |
| Incidents of total DVT | Randomisation to Post-Operative day 35 | |
| Incidents of proximal/distal DVT |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KRANKENHAUS DES BARMHER.SCHW.Linz | Linz | Austria | ||||
| AKH Wien |
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| Rivaroxaban |
| Drug |
Administered orally as a capsule once a day for 35 days |
|
|
| TB-402 | Drug | Administered intravenously over 10 minutes |
|
| Randomisation to Post-Operative day 35 |
| Incidents of pulmonary embolism | Randomisation to Post-Operative day 35 |
| Incidents of VTE-related death | Randomisation to Post-Operative day 35 |
| Incidents of Major VTE | Randomisation to Post-Operative day 70 |
| Vienna |
| Austria |
| Orthopädisches Spital Speising | Vienna | Austria |
| Klinikum Wels-Grieskirchen GmbH | Wels | Austria |
| ZNA Antwerpen Locatie Middelheim | Antwerp | Belgium |
| 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 | Bulgaria |
| Pándy Kálmán Kórház | Gyula | Hungary |
| Bács-Kiskun Megyei Önkormányzat Kórháza, Szegedi Tudományegyetem Általános Orvostudományi Karháza | Kecskemét | Hungary |
| Tolna Megyei Önkormányzat Balassa János Kórháza | Szekszárd | Hungary |
| Traumatology and Orthopedics Clinic "Adazi", LTD | Adazi | Latvia |
| Ltd "Liepajas regionala slimnica" | Liepāja | Latvia |
| Riga 2nd Hospital | Riga | Latvia |
| Ltd "Vidzemes slimnica" | Valmiera | Latvia |
| Diaconessenhuis Leiden | Leiden | Netherlands |
| Klinika Orthopedii I Traumatologii | Bialystok | Poland |
| Wojewódzkie Centrum Ortopedii i Rehabilitacji Narządu Ruchu im. dr Z. Radlińskiego w Łodzi | Lodz | Poland |
| NZOZ Szpital w Puszczykowie | Puszczykowo | Poland |
| Klinika Ortopedii, WIM | Warsaw | Poland |
| Medical University of warsaw, Dept of Orthopaedics | Warsaw | Poland |
| Municipal Healthcare Institution "City Clinical Hospital No. 3" | Chelabinsk | Russia |
| Municipal Healthcare Medical Institution "City Clinical Hospital No. 4" | Orenburg | Russia |
| Federal State Healthcare Institution: Clinical Hospital #122 named after L.G. Sokolov under the Federal Medical-Biological Agency of Russia | Saint Petersburg | Russia |
| Saint Petersburg State Healthcare Institution "City Aleksandrovskaya Hospital" | Saint Petersburg | Russia |
| Saint Petersburg State Healthcare Institution "Municipal Multi-Speciality Hospital No. 2" | Saint Petersburg | Russia |
| State Healthcare Institution "Samara Regional Clinical Hospital n.a. M.I. Kalinin" | Samara | Russia |
| Municipal Healthcare Institution "Clinical Hospital of Emergency Care n.a. N.V. Soloviov" | Yaroslavl | Russia |
| Public Entity "Regional Hospital - Center of Emergency Medical Care and Disaster Medicine" of Cherkasy Regional Council, Department of orthopedy and traumatology | Cherkassy | Ukraine |
| Ivano-Frankіvsk Regional Clinical Hospital MoH Ukraine, Department of ortopedics and traumatology. Department of traumatology, ortopedics and military/emergency surgery of Ivano-Frankіvsk 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. | Odesa | Ukraine |
| Public Establishment 'City Hospital #9', orthopedy and traumatology department | Sevastopol | Ukraine |
| ID | Term |
|---|---|
| C559990 | TB 402 |
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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