The purpose of the aPCC-emicizumab safety study is to investigate the hemostatic efficacy as measured by thrombin generation, of a low personalized dose of aPCC (FEIBA) in children and adults with hemophilia A and inhibitors on emicizumab prophylaxis.

开始日期2026-03-01

申办/合作机构

Emory University

[+1]

PACTR201901535105039

/ CompletedN/AIIT

Prospective study comparing between the effects of fibrinogen concentrate, and recombinant activated factor VII on reduction of blood products transfusion requirements in elective coronary artery bypass surgery

开始日期2017-11-01

申办/合作机构

Ain Shams University

NCT01757405

/ Completed临床3期

A PHASE 3, PROSPECTIVE, OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE SAFETY AND EFFICACY OF RECOMBINANT ACTIVATED FVII BI (rFVIIa BI) IN THE TREATMENT OF ACUTE BLEEDING EPISODES PER AN ON-DEMAND REGIMEN IN PATIENTS WITH HEMOPHILIA A OR B WITH INHIBITORS

The purpose of the study is to determine the efficacy and safety of rFVIIa BI as part of a six-month on-demand treatment regimen in hemophilia A or B subjects with inhibitors.

开始日期2013-02-20

申办/合作机构

Baxalta, Inc.

100 项与 BAX-817 相关的临床结果

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100 项与 BAX-817 相关的转化医学

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100 项与 BAX-817 相关的专利（医药）

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107

项与 BAX-817 相关的文献（医药）

2025-08-14·Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi

[Perioperative management of a patient with hemophilia a and high-titer inhibitors and literature review].

Review

作者: Dai, J ; Xu, G Q ; Wang, X F ; Xiang, J ; Meng, Z J ; Wu, W M ; Liu, Y ; Ding, Q L

A 64-year-old male patient with hemophilia A was scheduled for the surgical removal of a pulmonary mass. Preoperative evaluation revealed that the coagulation factor Ⅷ (FⅧ) activity was 0.5%, with an F Ⅷ inhibitor level of 32 BU/ml; the R value could not be detected on the thromboelastogram. Thoracoscopic lobectomy was successfully completed. On the day of the operation and the first day after the operation, 6 mg of recombinant activated coagulation factor Ⅶ (rFⅦa) was intravenously administered every 6 h. On postoperative day 1, the patient's blood pressure dropped and the HGB gradually declined from 102 g/L to 65 g/L. Chest X-ray revealed a large amount of pleural effusion on the left side, and urgent thoracoscopic thoracic exploration was performed. A total of 3200 mL fresh blood was cleared, and a thoracic drainage tube was placed. On postoperative day 2, the rFⅦa dose was increased to 6 mg, which was intravenously administered every 4 h, and concentrated red cells were intermittently infused to correct anemia. Four days later, due to the inability to obtain rFⅦa, PCC (50 IU/kg every 8 hours) was administered. Additionally, treatment with methylprednisolone (40 mg/d) and cyclophosphamide (200 mg, every 2 weeks) was initiated to remove FⅧ inhibitors. The thoracic drainage tube was removed on postoperative day 9, and the patient was successfully discharged 3 weeks later.

2024-08-01·Neurocritical care

Sex Differences in Perihematomal Edema Volume and Outcome After Intracerebral Hemorrhage

Article

作者: Luo, Yunshi ; Witsch, Jens ; McCullough, Louise D ; Sloane, Kelly L ; Rothstein, Aaron ; Favilla, Christopher G ; Cao, Quy ; Kasner, Scott E ; Gusdon, Aaron M ; Choi, Huimahn A ; Song, Jae W ; Cucchiara, Brett L ; Messé, Steve R ; Mayer, Stephan A

BACKGROUND:

Although larger hematoma volume is associated with worse outcome after intracerebral hemorrhage (ICH), the association between perihematomal edema (PHE) volume and outcome remains uncertain, as does the impact of sex on PHE and outcome. Here we aimed to determine whether larger PHE volume is associated with worse outcome and whether PHE volume trajectories differ by sex.

METHODS:

We conducted a post hoc analysis of the Factor VIIa for Acute Hemorrhagic Stroke Treatment (FAST) trial, which randomized patients with ICH to receive recombinant activated factor VIIa or placebo. Computerized planimetry calculated PHE and ICH volumes on serial computed tomography (CT) scans (at baseline [within 3 h of onset], at 24 h, and at 72 h). Generalized estimating equations examined interactions between sex, CT time points, and FAST treatment arm on PHE and ICH volumes. Mixed and multivariable logistic models examined associations between sex, PHE, and outcomes.

RESULTS:

A total of 781 patients with supratentorial ICH (mean age 65 years) were included. Compared to women (n = 296), men (n = 485) had similar median ICH (14.9 vs. 13.6 mL, p = 0.053) and PHE volumes (11.1 vs. 10.5 mL, p = 0.56) at baseline but larger ICH and PHE volumes at 24 h (19.0 vs. 14.0 mL, p < 0.001; 22.2 vs. 15.7 mL, p < 0.001) and 72 h (16.0 vs. 11.8 mL, p < 0.001; 28.7 vs. 19.9 mL, p < 0.001). Men had higher absolute early PHE expansion (p < 0.001) and more hematoma expansion (growth ≥ 33% or 6 mL at 24 h, 33% vs. 22%, p < 0.001). An interaction between sex and CT time points on PHE volume (p < 0.001), but not on ICH volume, confirmed a steeper PHE trajectory in men. PHE expansion (per 5 mL, odds radio 1.19, 95% confidence interval 1.10-1.28), but not sex, was associated with poor outcome.

CONCLUSIONS:

Early PHE expansion and trajectory in men were significantly higher. PHE expansion was associated with poor outcomes independent of sex. Mechanisms leading to sex differences in PHE trajectories merit further investigation.

2024-06-01·Journal of Obstetrics and Gynecology of India

Postpartum Hemorrhage: Enhancing Outcomes for Mothers by Effective Management

作者: Patel, Madhuri

Postpartum hemorrhage (PPH) remains a significant contributor to maternal morbidity and mortality worldwide. In India, PPH affects approximately 12% of women. The prevention and management of PPH are the significant challenges in obstetrics, with accurate assessment of blood loss and timely intervention being critical. Active Management of the Third Stage of Labor is a gold standard strategy for prevention. Recent advancements in PPH management include the use of recombinant activated factor VIIa, which has shown promise in decreasing the need for invasive procedures and second-line therapies. Additionally, surgical and radiological interventions have been effective in cases of refractory PPH. Overall, ongoing research and advancements in PPH management continue to enhance the quality of care and maternal outcomes experiencing this potentially life-threatening complication of childbirth. This editorial explores prevention and management of Atonic PPH with encompassing medical and surgical strategies, to enhance understanding and optimize clinical care for mothers at risk of this obstetric emergency.

项与 BAX-817 相关的新闻（医药）

2025-12-27

·梅斯医学

刷牙就出血、磕一下全是淤青，体检却次次正常？真正的问题藏在血小板“功能”里！

27岁的林女士（化名）因突发剧烈腹痛被紧急送医，CT显示腹腔内大量积血，血压一度降至60/40 mmHg，面色苍白如纸。医生怀疑黄体破裂或宫外孕，但妇科检查未见异常，血HCG阴性。更诡异的是，术中腹腔镜探查发现出血点来自肠系膜小血管渗血，像“关不紧的水龙头”，电凝止血后仍持续渗血，被迫中止手术。实验室检查显示，血小板计数正常（150×10⁹/L），但出血时间＞20分钟（正常＜9分钟），血小板聚集试验暴露致命缺陷——加入ADP、胶原、肾上腺素后，血小板竟“拒绝工作”，聚集率近乎为零！基因检测最终锁定祸首：GPIIb/IIIa复合体基因突变，确诊为血小板无力症——一种因血小板“罢工”导致止血功能崩溃的罕见遗传病！常染色体隐性遗传的出血疾病血小板无力症(Glanzmann thrombasthenia，GT)是一种罕见的常染色体隐性遗传的出血疾病，临床主要表现为自幼发生皮肤黏膜出血或创伤性出血，出血表现存在异质性。临床表现GT患者多在6岁前出现严重黏膜皮肤出血，常因碰撞、穿刺或口腔疾病诱发，表现为皮肤瘀点、鼻出血、牙龈出血、外伤后出血和消化道出血，少见血尿和关节出血。女性患者90.57%月经增多，部分有黄体破裂或不孕。出血严重程度与血小板数量不成比例，同基因型患者出血表现差异较大。I型和Ⅱ型GT出血较严重，Ⅲ型较轻，可长期无病生存。诊断GT诊断包括血小板计数、凝血试验、血小板功能检测及流式细胞术等。血小板计数和大小通常正常，但严重或慢性出血时可轻中度减少，血涂片显示血小板散在分布，不成堆。凝血试验表现为出血时间(BT)延长，PT、TT、APTT和纤维蛋白原正常，除非出现严重急性出血或消耗性凝血异常。血小板光学比浊法(LTA)是诊断GT的金标准，显示血小板对ADP等诱聚剂的聚集反应明显降低或缺失，但对瑞斯托霉素反应正常。PFA-100血小板功能筛选试验CT>300 s，若结果正常可排除GT。流式细胞术检测CD41 (GPⅡb) 和 CD61 (GPⅢa) 含量降低，可早期诊断和分型，但无法识别Ⅲ型GT的质量缺陷。血栓弹力图(TEG)显示血小板计数正常但最大振幅(MA)显著降低，可作为GT的辅助诊断依据。治疗GT治疗包括止血管理、血小板输注、造血干细胞移植(HSCT)和基因治疗。止血管理：避免外伤、手术，高危时提前预防。rFVⅡa对血小板输注无效者效果好，推荐90 μg/kg，每2小时一次。血小板输注：仅在大手术或危及生命出血时使用，避免抗体产生导致输注无效。造血干细胞移植：对于顽固性、危及生命出血患者，HSCT是唯一可治愈的方法，但风险较大。基因治疗：尚处于试验阶段，未来可能成为GT的有效治疗手段。参考资料：1.黎海燕,李保才,李丽君.血小板无力症的诊治新进展[J].临床输血与检验,2022,24(02):244-249.2.孙安霞.2例遗传性血小板无力症临床表型和基因型分析并文献复习[D].遵义医科大学,2019.3.周鹭,陈秀芳,江淼,等.血小板无力症97例临床发病特征分析[J].交通医学,2019,33(2):162-164.来源 | 梅斯医学编辑 | wanny神经系统罕见病交流群↓点击下方“阅读原文”，下载梅斯医学APP吧！

2025-04-24

·FierceBiotech

Bioxodes halts phase 2 stroke trial after successful interim review, plots registrational study

BIOX-101 is derived from a protein found in the salivary glands of a tick. \n Bioxodes has stopped enrolling people in a phase 2a stroke study after hitting the safety and efficacy endpoints, positioning the Belgian biotech to power into a potentially registrational trial.The interim phase 2a analysis included data on 16 intracerebral hemorrhagic stroke (ICH) patients. Some patients received a single intravenous dose of BIOX-101, also known as Ir-CPI, on top of standard of care. Other people only received standard of care. Bioxodes’ primary endpoints looked at safety outcomes. The biotech’s secondary endpoints assessed efficacy in the 10 days after randomization.At the interim analysis, the biotech saw positive changes in hematoma and edema volume, a secondary efficacy endpoint, and said inflammation biomarkers were encouraging. No patients died, and no serious adverse events were attributed to the drug. The treatment was well tolerated with no signs of increased bleeding.Hans Warrinnier, chief medical officer at Bioxodes, said in a statement that the results are preliminary but all point in the right direction. The biotech believes generating more phase 2a data won’t change the interim conclusions, leading it to stop enrollment in the study early. Bioxodes will now start raising a series B financing round and making BIOX-101 ready for a phase 2b trial. The process will take around one year, Bioxodes CEO Marc Dechamps said, putting the company on track to start enrolling patients in the potentially pivotal study in the first half of 2027. Bioxodes said the phase 2b could support filings for conditional marketing authorization in the U.S. and Europe before 2030.BIOX-101 is derived from a protein found in the salivary glands of a tick. The tick secretes the protein to stop the host’s blood from clotting and allow it to feed. Repurposed for treating ICH, the approach could tackle blood clots without causing bleeding. There are currently no approved treatments for ICH. Efforts to change that include a phase 3 study of recombinant factor VIIa (rFVIIa) that has an estimated complete date of January 2028. An earlier phase 3 trial found rFVIIa failed to improve survival or functional outcomes. That trial allowed patients to receive rFVIIa up to four hours after stroke onset. The ongoing rFVIIa trial has a treatment window of two hours.

临床结果临床2期临床3期

100 项与 BAX-817 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB00036

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
血友病	临床3期	-	Baxter BioScience Corp.	2015-03-13
血友病A	临床3期	美国	Baxalta, Inc.	2013-02-20
血友病A	临床3期	日本	Baxalta, Inc.	2013-02-20
血友病A	临床3期	波兰	Baxalta, Inc.	2013-02-20
血友病A	临床3期	罗马尼亚	Baxalta, Inc.	2013-02-20
血友病A	临床3期	俄罗斯	Baxalta, Inc.	2013-02-20
血友病A	临床3期	塞尔维亚	Baxalta, Inc.	2013-02-20
血友病A	临床3期	西班牙	Baxalta, Inc.	2013-02-20
血友病A	临床3期	中国台湾	Baxalta, Inc.	2013-02-20
血友病A	临床3期	乌克兰	Baxalta, Inc.	2013-02-20

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适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01757405 (CTgov)	临床3期	血友病B \| 血友病A	40	rFVIIa (Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI)	醖獵膚鹽顧齋繭壓網積 = 醖觸鑰鏇製顧鑰糧醖壓鹹構壓鑰蓋製膚衊簾襯 (鑰顧築夢積網簾齋願醖, 鹹糧鹽餘壓膚遞鑰鹹構 ~ 鏇鹽衊廠鏇遞窪選觸築) 更多	-	2016-10-25
				rFVIIa (Arm 2: 1 x 270 Micrograms/kg rFVIIa BI)	醖獵膚鹽顧齋繭壓網積 = 壓憲齋構製淵廠齋鏇齋鹹構壓鑰蓋製膚衊簾襯 (鑰顧築夢積網簾齋願醖, 積遞積簾願艱淵廠蓋膚 ~ 齋糧網齋醖淵觸糧觸襯) 更多
NCT01757405 (BusinessWire) 人工标引	临床3期	血友病B \| 血友病A	-	BAX-817 (dosing either 3x90µg/kg)	鬱艱繭築窪鏇醖醖構遞(艱遞遞夢糧窪齋醖廠廠) = 鬱鹽醖繭築遞鏇鬱鑰獵鏇範遞醖艱網積繭壓顧 (淵築鏇顧齋醖襯範夢獵 )	积极	2015-03-13
				BAX-817 (dosing either 1x270µg/kg)	鬱艱繭築窪鏇醖醖構遞(艱遞遞夢糧窪齋醖廠廠) = 顧壓獵製遞願艱簾顧鏇鏇範遞醖艱網積繭壓顧 (淵築鏇顧齋醖襯範夢獵 )