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172 results

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Filters applied: Meta-Analysis, Randomized Controlled Trial. Clear all
Page 1
Emicizumab Prophylaxis in Hemophilia A with Inhibitors.
Oldenburg J, Mahlangu JN, Kim B, Schmitt C, Callaghan MU, Young G, Santagostino E, Kruse-Jarres R, Negrier C, Kessler C, Valente N, Asikanius E, Levy GG, Windyga J, Shima M. Oldenburg J, et al. N Engl J Med. 2017 Aug 31;377(9):809-818. doi: 10.1056/NEJMoa1703068. Epub 2017 Jul 10. N Engl J Med. 2017. PMID: 28691557 Free article. Clinical Trial.
BACKGROUND: Emicizumab (ACE910) bridges activated factor IX and factor X to restore the function of activated factor VIII, which is deficient in persons with hemophilia A. This phase 3, multicenter trial assessed once-weekly subcutaneous emicizumab pro …
BACKGROUND: Emicizumab (ACE910) bridges activated factor IX and factor X to restore the function of activated factor
Emicizumab Prophylaxis in Patients Who Have Hemophilia A without Inhibitors.
Mahlangu J, Oldenburg J, Paz-Priel I, Negrier C, Niggli M, Mancuso ME, Schmitt C, Jiménez-Yuste V, Kempton C, Dhalluin C, Callaghan MU, Bujan W, Shima M, Adamkewicz JI, Asikanius E, Levy GG, Kruse-Jarres R. Mahlangu J, et al. N Engl J Med. 2018 Aug 30;379(9):811-822. doi: 10.1056/NEJMoa1803550. N Engl J Med. 2018. PMID: 30157389 Free article. Clinical Trial.
BACKGROUND: Emicizumab is a bispecific monoclonal antibody that bridges activated factor IX and factor X to replace the function of missing activated factor VIII, thereby restoring hemostasis. In a phase 3, multicenter trial, we investigated its use as …
BACKGROUND: Emicizumab is a bispecific monoclonal antibody that bridges activated factor IX and factor X to replace the …
Efficacy and Safety of Early Administration of 4-Factor Prothrombin Complex Concentrate in Patients With Trauma at Risk of Massive Transfusion: The PROCOAG Randomized Clinical Trial.
Bouzat P, Charbit J, Abback PS, Huet-Garrigue D, Delhaye N, Leone M, Marcotte G, David JS, Levrat A, Asehnoune K, Pottecher J, Duranteau J, Courvalin E, Adolle A, Sourd D, Bosson JL, Riou B, Gauss T, Payen JF; PROCOAG Study Group. Bouzat P, et al. JAMA. 2023 Apr 25;329(16):1367-1375. doi: 10.1001/jama.2023.4080. JAMA. 2023. PMID: 36942533 Free PMC article. Clinical Trial.
Reports suggest a beneficial effect of 4-factor prothrombin complex concentrate (4F-PCC) on blood product consumption. OBJECTIVE: To investigate the efficacy and safety of 4F-PCC administration in patients at risk of massive transfusion. ...INTERVENTIONS: Intravenous admin …
Reports suggest a beneficial effect of 4-factor prothrombin complex concentrate (4F-PCC) on blood product consumption. OBJECTIVE: To …
Gene Therapy with Fidanacogene Elaparvovec in Adults with Hemophilia B.
Cuker A, Kavakli K, Frenzel L, Wang JD, Astermark J, Cerqueira MH, Iorio A, Katsarou-Fasouli O, Klamroth R, Shapiro AD, Hermans C, Ishiguro A, Leavitt AD, Oldenburg JB, Ozelo MC, Teitel J, Biondo F, Fang A, Fuiman J, McKay J, Sun P, Rasko JEJ, Rupon J; BENEGENE-2 Trial Investigators. Cuker A, et al. N Engl J Med. 2024 Sep 26;391(12):1108-1118. doi: 10.1056/NEJMoa2302982. N Engl J Med. 2024. PMID: 39321362 Clinical Trial.
BACKGROUND: Fidanacogene elaparvovec, an adeno-associated virus (AAV) gene-therapy vector for hemophilia B containing a high-activity human factor IX variant (FIX-R338L/FIX-Padua), was associated with sustained factor IX activity in a phase 1-2a study. …
BACKGROUND: Fidanacogene elaparvovec, an adeno-associated virus (AAV) gene-therapy vector for hemophilia B containing a high-activity human …
Efficacy and safety of a 4-factor prothrombin complex concentrate in patients on vitamin K antagonists presenting with major bleeding: a randomized, plasma-controlled, phase IIIb study.
Sarode R, Milling TJ Jr, Refaai MA, Mangione A, Schneider A, Durn BL, Goldstein JN. Sarode R, et al. Circulation. 2013 Sep 10;128(11):1234-43. doi: 10.1161/CIRCULATIONAHA.113.002283. Epub 2013 Aug 9. Circulation. 2013. PMID: 23935011 Free PMC article. Clinical Trial.
We performed a prospective clinical trial to compare nonactivated 4-factor prothrombin complex concentrate (4F-PCC) with plasma for urgent vitamin K antagonist reversal. METHODS AND RESULTS: In this phase IIIb, multicenter, open-label, noninferiority trial, nonsurgical pat …
We performed a prospective clinical trial to compare nonactivated 4-factor prothrombin complex concentrate (4F-PCC) with plasma for u …
Factor IX complex for the treatment of severe bleeding after cardiac surgery.
Clark KB, Kon ND, Hammon JW Jr, MacGregor DA, Kincaid EH, Reichert MG. Clark KB, et al. J Cardiovasc Pharmacol. 2013 Jul;62(1):67-71. doi: 10.1097/FJC.0b013e318290922f. J Cardiovasc Pharmacol. 2013. PMID: 23519139 Clinical Trial.
The mean dose of Factor IX Complex was 35 (13-52) units/kg. Chest tube output was significantly reduced after Factor IX Complex administration (mean pre-Factor IX Complex 381 49 mL/h, mean post-Factor IX Complex 151 38 mL/h; …
The mean dose of Factor IX Complex was 35 (13-52) units/kg. Chest tube output was significantly reduced after Factor
Plasma levels of coagulation factors VIII and IX and risk of venous thromboembolism: Systematic review and meta-analysis.
Lowe G, Wu O, van Hylckama Vlieg A, Folsom A, Rosendaal F, Woodward M. Lowe G, et al. Thromb Res. 2023 Sep;229:31-39. doi: 10.1016/j.thromres.2023.06.026. Epub 2023 Jun 28. Thromb Res. 2023. PMID: 37390526 Free PMC article.
INTRODUCTION: The associations of plasma factor VIII (FVIII) and factor IX (FIX) levels with risk of venous thromboembolism (VTE) are not well defined. ...RESULTS: Among 15 studies (5327 cases) the pooled odds ratio of VTE for the fourth versus first quarter …
INTRODUCTION: The associations of plasma factor VIII (FVIII) and factor IX (FIX) levels with risk of venous thromboembo …
Increased bone resorption in hemophilia.
Rodriguez-Merchan EC, Valentino LA. Rodriguez-Merchan EC, et al. Blood Rev. 2019 Jan;33:6-10. doi: 10.1016/j.blre.2018.05.002. Epub 2018 May 25. Blood Rev. 2019. PMID: 29857920 Review.
Seralutinib in adults with pulmonary arterial hypertension (TORREY): a randomised, double-blind, placebo-controlled phase 2 trial.
Frantz RP, McLaughlin VV, Sahay S, Escribano Subías P, Zolty RL, Benza RL, Channick RN, Chin KM, Hemnes AR, Howard LS, Sitbon O, Vachiéry JL, Zamanian RT, Cravets M, Roscigno RF, Mottola D, Osterhout R, Bruey JM, Elman E, Tompkins CA, Parsley E, Aranda R, Zisman LS, Ghofrani HA; TORREY Study Investigators. Frantz RP, et al. Lancet Respir Med. 2024 Jul;12(7):523-534. doi: 10.1016/S2213-2600(24)00072-9. Epub 2024 May 2. Lancet Respir Med. 2024. PMID: 38705167 Clinical Trial.
BACKGROUND: Morbidity and mortality in pulmonary arterial hypertension (PAH) remain high. Activation of platelet-derived growth factor receptor, colony stimulating factor 1 receptor, and mast or stem cell growth factor receptor kinases stimulates inflammatory …
BACKGROUND: Morbidity and mortality in pulmonary arterial hypertension (PAH) remain high. Activation of platelet-derived growth factor
Multicentre, randomized, open-label study of on-demand treatment with two prophylaxis regimens of recombinant coagulation factor IX in haemophilia B subjects.
Valentino LA, Rusen L, Elezovic I, Smith LM, Korth-Bradley JM, Rendo P. Valentino LA, et al. Haemophilia. 2014 May;20(3):398-406. doi: 10.1111/hae.12344. Epub 2014 Jan 13. Haemophilia. 2014. PMID: 24418368 Clinical Trial.
Few randomized studies have reported on the use of factor IX (FIX) for secondary prophylaxis in haemophilia B patients. This study aimed to evaluate the efficacy and safety of two secondary prophylaxis regimens of recombinant coagulation FIX, nonacog alfa, co …
Few randomized studies have reported on the use of factor IX (FIX) for secondary prophylaxis in haemophilia B patients. This s …
172 results