Single Intravenous Administration of TB-402 for the Prophylaxis of Venous Thromboembolic Events (VTE) After Total Knee Replacement Surgery
Single Intravenous Administration of TB-402 for the Prophylaxis of Venous Thromboembolic Events (VTE) After Total Knee Replacement Surgery: A Dose-Escalating, Multicenter, Randomised, Active- Controlled Open Label Study
調査の概要
詳細な説明
Currently available anticoagulant therapies for the prevention of VTE include low molecular weight heparins, pentasaccharides and vitamin K antagonists, all of which have inherent limitations(1-3).
Improved anticoagulant agents are therefore required(4). A novel antithrombotic agent requires demonstration of both efficacy and safety in relevant populations. Phase II studies are frequently performed in patients undergoing total hip replacement and/or total knee replacement because of the high and well documented incidence of deep vein thrombosis in the absence of adequate thromboprophylaxis(5-7).
In this study, we assess the safety and efficacy of TB-402, a novel antithrombotic agent that partially inhibits factor VIII, in the prevention of VTE in patients undergoing total knee replacement surgery.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Beer - Sheva、イスラエル、84101
- Soroka MC
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Beer-Yaakov、イスラエル、70300
- Asaf Harofeh MC
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Haifa、イスラエル、31096
- Rambam MC
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Jerusalem、イスラエル、91031
- Shaare Zedek Mc
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Kfar Saba、イスラエル、44281
- Meir Medical Center (MC)
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Petach Tikva、イスラエル、49100
- Beilinson Hospital
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Rehovot、イスラエル、76100
- Kaplan MC
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Tel Aviv、イスラエル、64239
- Sourasky MC
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Cherkassy、ウクライナ、18009
- Cherkasska Regional Hospital. Department of Orthopedics and Traumatology.
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Ivano-Frankivsk、ウクライナ、76008
- Ivano-Frankіvsk Regional Clinical Hospital, Department of ortopedics and traumatology.
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Odessa、ウクライナ、65025
- Odessa Regional Clinical Hospital, Department of Orthopedics and Traumatology
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Pleven、ブルガリア、5800
- SHAT of orthopedics, traumatology and surgery "Sv. Pantaleimon " - Pleven Department of Orthopaedics and Traumatology
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Plovdiv、ブルガリア、4002
- Dept. of Orthopedics, UMHAT "Saint George"
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Rousse、ブルガリア、7002
- MHAT Rousse
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Sofia、ブルガリア、1709
- MHAT "Sveta Anna" AD - Sofia, Clinic of Orthopedics and Traumatology
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Varna、ブルガリア、9000
- MHAT "Sv. Anna", Department of Orthopaedics and Traumatology
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Bydgoszcz、ポーランド、85-094
- Szpital Uniwersytecki im. dr. Antoniego Jurasza w Bydgoszczy Klinika Ortopedii i Traumatologii Narządu Ruchu
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Kraków、ポーランド、31-826
- Wojewódzki Szpital Specjalistyczny im. L. Rydygiera w Krakowie, Oddział Kliniczny Ortopedii i Traumatologii Narządu Ruchu
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Lubuskie、ポーランド、20-090
- Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie, Katedra i Klinika Ortopedii Traumatologii i Rehabilitacji
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Podlaski、ポーランド、15-276
- Uniwersytecki Szpital Kliniczny w Białymstoku, Klinika Ortopedii i Traumatologii
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Warszawa、ポーランド、03-242
- Wojewódzki Szpital Bródnowski Samodzielny Publiczny Zakład Opieki Zdrowotnej, Oddział Chirurgii Urazowo-Ortopedycznej i Rehabilitacji
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Liepāja、ラトビア、LV-3400
- Ltd "Liepajas regionala slimnica"
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Riga、ラトビア、LV-1005
- Ltd "Traumatologijas un ortopedijas slimnica"
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Valmiera、ラトビア、LV 4201
- Vidzemes slimnica
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Bucuresti、ルーマニア、042122
- Spitalul Clinic de Urgenta Sf. Ioan Bucuresti
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Cluj - Napoca、ルーマニア、400132
- Spitalul Clinic de Urgenta Prof. Dr. Octavian Fodor CLUJ NAPOCA
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Craiova、ルーマニア、200642
- Spitalul Clinic Judetean de Urgenta Craiova
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Cheliabinsk、ロシア連邦、454136
- Municipal Healthcare Institution "City Clinical Hospital No. 3"
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Moscow、ロシア連邦、111539
- Moscow State Healthcare Institution "City Clinical Hospital No. 15 n.a. O.M. Filatov"
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Orenburg、ロシア連邦、460000
- Municipal Healthcare Institution "City Clinical Hospital No. 4"
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Saint Petersburg、ロシア連邦、194291
- Federal State Medical Institution: Clinical Hospital #122 named after L.G. Sokolov under the Federal Medical-Biological Agency
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Saint Petersburg、ロシア連邦、194354
- Saint Petersburg State Healthcare Institution "Municipal Multi-Speciality Hospital No. 2"
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Saint Petersburg、ロシア連邦、197046
- Federal State Institution "Russian Research Institute of Traumatology and Orthopedics n.a. R.R. Vreden under the Federal Authority for Healthcare and Social Development"
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Saint-Petersburg、ロシア連邦、193312
- Saint Petersburg State Healthcare Institution "Aleksandrovskaya Hospital"
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Samara、ロシア連邦、443095
- State Healthcare Institution "Samara Regional Clinical Hospital n.a. M.I. Kalinin"
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Male or female patients aged > 18 and < 80 years old
- Female patients should be post menopausal
- Patients undergoing primary elective total knee replacement surgery
- Written informed consent obtained from the patient (or a legally acceptable representative) prior to inclusion in the study
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
Exclusion Criteria:
- Body weight < 50 kg or > 100 kg
- Patients undergoing a hemiarthroplasty, surface repair or revisionary surgery of the knee
- Confirmed symptomatic deep vein thrombosis or pulmonary embolism within the past year
- Anticipated use of indwelling intrathecal or epidural catheter for more than 4 h after surgery or during the entire study
- Uncontrolled hypertension (SBP>160 mm Hg or DBP > 100 mm Hg)
- History of intracranial or intraocular bleeding. History of gastrointestinal and/or endoscopically verified ulcer disease within the past year
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
アクティブコンパレータ:4
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Enoxaparin 40mg/day sc injection for at least 10 days post-surgery
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実験的:1
0.3 mg/kg TB-402
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TB-402 administered as single bolus 18-24 post total knee replacement surgery.
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実験的:2
0.6 mg/kg TB-402
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TB-402 administered as single bolus 18-24 post total knee replacement surgery.
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実験的:3
1.2 mg/kg TB-402
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TB-402 administered as single bolus 18-24 post total knee replacement surgery.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
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The occurrence of total bleeding defined as major and/or clinically relevant non-major bleeding events, from randomisation until the end of the study.
時間枠:All visists from randomization to end of study
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All visists from randomization to end of study
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Composite of the occurrence of asymptomatic DVT as detected by bilateral venography and symptomatic VTE, i.e. DVT or fatal or non-fatal PE.
時間枠:Prior to hospital discharge Day 7-11
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Prior to hospital discharge Day 7-11
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二次結果の測定
結果測定 |
時間枠 |
---|---|
Incidence of major bleeding events
時間枠:All visists from randomization to end of study
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All visists from randomization to end of study
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Incidence of clinically significant non-major bleeding events
時間枠:All visits from randomization to end of study
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All visits from randomization to end of study
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Incidence of minor bleeding events
時間枠:All visits from randomization to end of study
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All visits from randomization to end of study
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Incidence of all cause mortality
時間枠:All visits from randomization to end of study
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All visits from randomization to end of study
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Incidence of adverse events
時間枠:All visists from randomization to end of study
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All visists from randomization to end of study
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
TB-402の臨床試験
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ThromboGenicsBioInvent International AB完了
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University of OxfordCrucell Holland BV; University of Birmingham; Emergent BioSolutions; Aeras完了
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Peter MacCallum Cancer Centre, Australia積極的、募集していない
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Assistance Publique - Hôpitaux de Paris完了