Rivaroxaban in Pediatric Patients With DVT
Safety and Efficacy of Rivaroxaban in Pediatric Patients With Deep Venous Thrombosis
調査の概要
詳細な説明
Treatment of deep venous thrombotic events in children is based on data obtained in adults with little direct documentation of its efficacy and safety in children. Rivaroxaban is a direct oral anticoagulant which has been approved by FDA in 2021 for the use in pediatric patients with venous thrombosis.
In a randomized controlled trial we will study the safety and efficacy of rivaroxaban use in the pediatric population with acute deep venous thrombosis.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Cairo、エジプト、11566
- Ain Shams University Children's Hospital
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Patients from 6 months to less than 18 years of age.
- Patients with acute deep venous thrombosis diagnosed based on site-appropriate imaging tools e.g., magnetic resonance venography (MRV) in Cerebral sinus venous thrombosis (CSVT), venous duplex in Central Venous Access Devices (CVAD) related thrombosis or other non-CSVT DVT.
- Patients with cancer associated thrombosis are eligible.
- Patients with provoked or unprovoked acute VT are eligible.
- Patients with first thrombotic event or recurrent VT are eligible.
Exclusion Criteria:
- Patients with active bleeding
High-risk of bleeding including:
- Platelet count of less than 50 x 109/L,
- Liver disease associated either a coagulopathy leading to a clinically relevant bleeding risk, or ALT > 5× ULN.
- Sustained uncontrolled hypertension defined as systolic and/or diastolic blood pressure > 95th age percentile.
- Severe renal impairment (Estimated glomerular filtration rate < 30 mL/min/1.73m2).
- Gastrointestinal disease associated with impaired absorption.
- Hypersensitivity or any other contraindication listed in the local labelling for Rivaroxaban or comparator treatment.
- Patients with rheumatic heart disease or prosthetic heart valves.
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：処理
- 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 |
|---|---|
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アクティブコンパレータ：LMWH arm
Patients assigned to LMWH will receive standard anticoagulation with enoxaparin sodium at a dose 1mg/kg twice daily for 3 months duration.
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Patients in arm 1 will receive standard anticoagulation with enoxaparin sodium at a dose 1mg/kg twice daily for 3 months duration
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実験的：Rivaroxaban
Patients allocated to Rivaroxaban: after 5 to 9 days of therapy with low molecular weight heparin (LMWH), patients will receive body weight-adjusted 20-mg equivalent doses with an age-appropriate serving of fluid given with or shortly after a meal. Crushed Rivaroxaban tablet is stable for up to 4 hours and displays similar relative bioavailability compared to a whole tablet administered orally. |
Patients allocated to Rivaroxaban arm: after 5 to 9 days of therapy with low molecular weight heparin (LMWH), patients will receive body weight-adjusted 20-mg equivalent doses with an age-appropriate serving of fluid given with or shortly after a meal. Crushed Rivaroxaban tablet is stable for up to 4 hours and displays similar relative bioavailability compared to a whole tablet administered orally. |
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Degree of vein recanalization
時間枠：3 months
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A Repeat site-appropriate imaging at 3 months will be done to assess the degree of vein recanalization and response will be classified as
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3 months
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Fatma SE Ebeid, MD、Faculty of Medicine Ain Shams University
- 主任研究者：Amira Adly、Faculty of Medicine Ain Shams University
出版物と役立つリンク
一般刊行物
- Moore KT, Krook MA, Vaidyanathan S, Sarich TC, Damaraju CV, Fields LE. Rivaroxaban crushed tablet suspension characteristics and relative bioavailability in healthy adults when administered orally or via nasogastric tube. Clin Pharmacol Drug Dev. 2014 Jul;3(4):321-7. doi: 10.1002/cpdd.123. Epub 2014 May 16.
- Lensing AWA, Male C, Young G, Kubitza D, Kenet G, Patricia Massicotte M, Chan A, Molinari AC, Nowak-Goettl U, Pap AF, Adalbo I, Smith WT, Mason A, Thelen K, Berkowitz SD, Crowther M, Schmidt S, Price V, Prins MH, Monagle P. Rivaroxaban versus standard anticoagulation for acute venous thromboembolism in childhood. Design of the EINSTEIN-Jr phase III study. Thromb J. 2018 Dec 21;16:34. doi: 10.1186/s12959-018-0188-y. eCollection 2018.
- Young G, Lensing AWA, Monagle P, Male C, Thelen K, Willmann S, Palumbo JS, Kumar R, Nurmeev I, Hege K, Bajolle F, Connor P, Hooimeijer HL, Torres M, Chan AKC, Kenet G, Holzhauer S, Santamaria A, Amedro P, Beyer-Westendorf J, Martinelli I, Massicotte MP, Smith WT, Berkowitz SD, Schmidt S, Price V, Prins MH, Kubitza D; EINSTEIN-Jr. Phase 3 Investigators. Rivaroxaban for treatment of pediatric venous thromboembolism. An Einstein-Jr phase 3 dose-exposure-response evaluation. J Thromb Haemost. 2020 Jul;18(7):1672-1685. doi: 10.1111/jth.14813. Epub 2020 Jun 4.
- Male C, Lensing AWA, Palumbo JS, Kumar R, Nurmeev I, Hege K, Bonnet D, Connor P, Hooimeijer HL, Torres M, Chan AKC, Kenet G, Holzhauer S, Santamaria A, Amedro P, Chalmers E, Simioni P, Bhat RV, Yee DL, Lvova O, Beyer-Westendorf J, Biss TT, Martinelli I, Saracco P, Peters M, Kallay K, Gauger CA, Massicotte MP, Young G, Pap AF, Majumder M, Smith WT, Heubach JF, Berkowitz SD, Thelen K, Kubitza D, Crowther M, Prins MH, Monagle P; EINSTEIN-Jr Phase 3 Investigators. Rivaroxaban compared with standard anticoagulants for the treatment of acute venous thromboembolism in children: a randomised, controlled, phase 3 trial. Lancet Haematol. 2020 Jan;7(1):e18-e27. doi: 10.1016/S2352-3026(19)30219-4. Epub 2019 Nov 5.
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- FMASU MD 156/2024
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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Enoxaparin, Heparinの臨床試験
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IRCCS Azienda Ospedaliero-Universitaria di Bolognaわからない