A Phase 1, Open-Label, Single-Dose, Non-Randomized Study to Evaluate Pharmacokinetics, Pharmacodynamics, and Safety of Betrixaban in Pediatric Patients

This trial was a Phase 1, open-label, multicenter study of the pharmacokinetics (PK), pharmacodynamics (PD), and safety of a single dose of betrixaban in pediatric participants at risk of venous thromboembolism (VTE).

开始日期2018-07-13

申办/合作机构

Alexion Pharmaceuticals, Inc.

[+1]

NCT03397888

/ Completed临床1期

The Effect o f Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Betrixiban, an Oral FXa Antagonist

Single center, prospective open label PK and PD study of betrixaban in subjects with mild and moderate hepatic impairment vs healthy volunteers.

开始日期2017-11-16

申办/合作机构

Portola Pharmaceuticals LLC

NCT02596100

/ Completed临床1期

A Bioequivalence Study to Compare the Pharmacokinetics of Two Betrixaban Formulations

This is a single center open label randomized 4-period 2-sequence replicated crossover design study. A total of 52 healthy subjects will be randomized.

开始日期2015-09-01

申办/合作机构

Portola Pharmaceuticals LLC

100 项与贝曲沙班相关的临床结果

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100 项与贝曲沙班相关的转化医学

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100 项与贝曲沙班相关的专利（医药）

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项与贝曲沙班相关的文献（医药）

2026-03-01·International Journal of Surgery

Anticoagulant-associated bleeding: real-world data-driven pharmacovigilance and insights for bleeding management

Article

作者: Li, Liu-Cheng ; Wei, Qun ; Hong, Xia ; Mao, Kai-Li ; Wang, Yu-Zhen ; Wang, Zi-Lian

Background::

Anticoagulant drugs are essential for managing thrombotic diseases but lead to increasing bleeding risk. The choice of suitable anticoagulant drugs requires an assessment of the patient’s thrombotic risk factors and underlying ischemic pathology.

Methods::

This study constructs a closed-loop framework integrating qualitative literature review and quantitative data analysis to evaluate bleeding risks in anticoagulant therapy. The qualitative review covers molecular mechanisms, risk factors, and nursing practices related to anticoagulant drugs. Quantitatively, we analyzed the bleeding events from the FDA Adverse Event Reporting System (FAERS) database (2004–2024), using disproportionality analysis with Reporting Odds Ratio, Proportional Reporting Ratio, Bayesian Confidence Propagation Neural Network, and Empirical Bayes Geometric Mean to identify significant bleeding signals. For each anticoagulant drug, the 10 strongest signals were extracted and anatomically profiled to construct a drug-specific hemorrhage atlas. Logistic regression analyses were applied to investigate the effects of age, sex, reporter, and comorbidities on the occurrence of anticoagulant drugs-associated bleeding. To address the critical issue of bleeding risk management in the clinic, we further discussed the multidisciplinary nursing across the anticoagulation therapy cycle.

Results::

The study revealed significant variations in bleeding risks among different anticoagulants. Anticoagulant-associated bleeding comprised 110 701 reports from FAERS database. Elderly patients (≥65 years old) supplied 63.2% of cases; 32% of events emerged within 30 days of therapy initiation. Hospitalization was documented in 46.8% and death in 20.7%. Spinal subdural hemorrhage yielded the highest signal (ROR 144.79, 95% CI 28.09–746.33), followed by adrenal, mesenteric, and intracranial hemorrhages among all anticoagulant drugs. Gastric/lower gastrointestinal bleeding appeared in the top-10 list of every oral anticoagulant, while retroperitoneal bleeding was a shared high-signal event among heparins and parenteral direct thrombin inhibitors. Betrixaban exhibited extreme RORs for traumatic (ROR 18 059.67, 95% Cl: 8829.21–36 940.05) and intracranial (ROR 643.97, 95% Cl: 249.82–1660) bleeding. Each drug also exhibited distinct bleeding characteristics and differences in organ system distribution. Multivariable logistic regression across four hierarchical models identified agents with distinct, model-independent bleeding risk profiles relative to warfarin.

Conclusions::

This large-scale pharmacovigilance study provides the most comprehensive, publicly available atlas of anticoagulant-related bleeding signals. The pronounced inter-drug heterogeneity and persistent long-term risk mandate individualized choice of agent and prolonged monitoring to ultimately improve the safety–efficacy balance of antithrombotic therapy.

2026-01-01·CLINICA CHIMICA ACTA

Clinical laboratory testing of blood from patients presenting to the emergency department with acute bleeding due to factor Xa inhibitors: An unmet medical need

Review

作者: Peacock, W Franklin ; Wu, Alan H B

Bleeding is a life-threatening side effect of oral anticoagulants and can be a medical emergency. For patients on warfarin, stat testing of blood for the prothrombin time and calculation of the International Ratio (PT-INR) are used to determine if acute bleeding is caused by excess anticoagulation. Direct acting oral anticoagulants (DOACs) include those that inhibit Factor Xa (apixaban, rivaroxaban, edoxaban, and betrixaban) or Factor IIa (dabagatran). Unlike warfarin, there are no recommendations for regular monitoring of DOAC drug levels. Testing is useful for bleeding patients if a reversal agent is being considered. In addition, the use of thrombolytic therapy is contraindicated for the treatment of an ischemic stroke for a patient on a DOAC. However, current laboratory assays for anti-Factor Xa are calibrated for the specific DOAC used and results are not typically available in emergency departments. Therefore, there is a need to produce a rapid bedside blood test that can detect bleeding to any DOAC drug that was prescribed.

2025-10-21·NEUROLOGY

Intracranial Hemorrhage With Direct Oral Anticoagulants vs Low-Molecular-Weight Heparin in Brain Tumors

Review

作者: Rhee, John Y. ; Fuse, Kenshiro ; Goulart, Thiago Oscar ; Wang, Chen ; Zambrano, Daniela ; Bukhari, Yasir

BACKGROUND AND OBJECTIVES:

Patients with brain tumors face an increased risk of arterial and venous thromboembolic events. However, owing to risk of intracranial hemorrhage (ICH), clinician practice patterns vary on preference for anticoagulation treatment. This meta-analysis evaluates the safety of direct oral anticoagulants (DOACs) vs low-molecular-weight heparin (LMWH) on the development of ICH in patients with brain tumor.

METHODS:

We searched MEDLINE, Embase, Web of Science, and Cochrane Central Register of Controlled Trials (January 2010-June 2025) for randomized-controlled trials or cohort studies enrolling adults (age ≥18 years) with primary or metastatic brain tumors receiving therapeutic DOACs (apixaban, rivaroxaban, edoxaban, betrixaban, and dabigatran) vs LMWH (enoxaparin, dalteparin, nadroparin, and tinzaparin). Studies limited to prophylactic dosing or non-brain tumor patients were excluded. Pooled risk ratios (RRs) with 95% CIs were calculated using a restricted random-effects model. Heterogeneity (I²) and bias were evaluated, with prespecified subgroups (tumor type, follow-up duration, and study quality) and sensitivity analyses. The study protocol was registered on PROSPERO (CRD42025635334).

RESULTS:

Among 762 publications identified, 10 retrospective cohort studies (1,572 patients: 645 DOAC, 895 LMWH) were included. Patients' mean or median age ranged 60.4-67 years (DOAC) vs 53-64 years (LMWH), with follow-up durations ranging from 3 to 12 months. Patients with primary or metastatic brain tumors receiving DOACs had a statistically significantly lower risk of any ICH compared with LMWH (RR = 0.50, 95% CI 0.29-0.87; p = 0.01, I² = 49.50%). Reduction was more pronounced in 3 studies with three-month follow-up (RR = 0.23, 95% CI 0.09-0.57; p < 0.01, I² < 0.01%). Stratified analyses showed reduced ICH risk with DOACs in primary brain tumors (5 studies, RR = 0.20, 95% CI 0.08-0.54; p < 0.01, I² < 0.01%) but not in metastatic brain tumors (5 studies, RR = 0.86, 95% CI 0.44-1.68; p = 0.66, I² = 36.04%). Leave-one-out analyses confirmed robustness, and cumulative meta-analysis demonstrated stable estimates with narrowing CIs. Egger (p = 0.19) and Begg (p = 0.59) tests showed no statistical evidence of publication bias.

DISCUSSION:

In the current meta-analysis, DOACs were associated with significantly lower ICH risk than LMWH in patients with anticoagulated brain tumor, particularly those with primary brain tumors. Findings support DOACs as a safe anticoagulant in arterial and venous thromboembolism. Given observational designs with inherent confounding, findings warrant cautious interpretation.

项与贝曲沙班相关的新闻（医药）

2026-05-18

·研日新

研日新日报 ·2| 05月18日风湿免疫科 | 呼吸内科 | 重症医学科

日报精选医学文献今日精选20篇医学文献，查看更多请点击阅读原文本文支持继续浏览摘要内容；完整摘要、收藏文章、订阅管理等完整功能，请前往小程序「医研日新」。前往小程序查看更多与订阅收藏 1. Oxygen-Vacancy-Engineered WOX Nanowire-Based Surface-Enhanced Raman Scattering Biosensor with Lyophilized CRISPR/Cas13a Platform for CHIKV Detection. [Arthritis] ACS sensors | 2026-05-14 | IF 8.2 AI该CRISPR/Cas13a-SERS检测平台可实现CHIKV的床边快速诊断，检测限达亚拷贝级别，为临床早期发现和疫情监测提供了高灵敏、低成本的分子诊断新选择。摘要The outbreak of Chikungunya virus (CHIKV) has caused widespread acute morbidity with severe polyarthralgia or chronic arthritis, placing a great challenge to public health and socioeconomic development. Establishing a rapid and highly sensitive detection technology is crucial for achieving precise control and prevention. Here, we established a CRISPR/Cas13a-mediated SERS lateral flow immunoassay p...查看完整摘要 2. Modulation of the mevalonate pathway by TCR engagement regulates T follicular helper cell generation in homeostasis and autoimmunity. [Autoimmune Diseases] Immunity | 2026-05-14 | IF 7.9 AIMVA通路代谢产物GGPP是Tfh细胞功能的关键调控节点，匹伐他汀可通过靶向该通路选择性抑制致病性Tfh细胞，为自身免疫病治疗提供新思路。摘要Surface proteins enable T follicular helper (Tfh) cells' chemotactic migration toward B cells and subsequent functional interactions, underpinning effective humoral immunity. We showed that geranylgeranyl diphosphate (GGPP), a mevalonate (MVA) pathway-derived isoprenoid, was indispensable for Tfh cell function by maintaining surface protein expression. Either pharmacological inhibition or genetic ...查看完整摘要 3. Retraction notice to "Molecular mechanism and role of miRNA-155 ribonucleic acid in podocyte apoptosis in lupus nephritis: SOCS1 protein expression regulates JAK/STAT pathway transduction" [Int. J. Biol. Macromol. 304 (2025) 140810]. [Lupus Nephritis] Published Erratum | International journal of biological macromolecules | 2026-05-14 | IF 7.7 AI该研究虽因某些原因被撤稿，但狼疮性肾炎中miRNA-155/SOCS1/JAK-STAT通路调控足细胞损伤的机制仍具潜在研究价值。 4. Can we cure primary biliary cholangitis? [Autoimmune Diseases] 综述 | Current opinion in immunology | 2026-05-14 | IF 6.6 AIPBC的传统治疗以延缓疾病进展为主，但调节性T细胞调控、抗原特异性耐受及表观遗传干预等新兴免疫调节策略为实现疾病治愈提供了潜在可能。摘要Primary biliary cholangitis (PBC) is a chronic immune-mediated liver disease characterized by progressive destruction of the intrahepatic bile ducts, leading to cholestasis, fibrosis, and eventual cirrhosis. Despite advances in understanding disease pathogenesis, treatment pathways are focused on maintenance rather than cure. Moreover, the lion's share of therapeutic advances have been in the bile...查看完整摘要 5. Osteoporosis knowledge, health beliefs, and self-efficacy in UK men with prostate cancer: a cross-sectional primary care survey. [Osteoporotic Fractures] The British journal of general practice : the journal of the Royal College of General Practitioners | 2026-05-14 | IF 5.3 AI前列腺癌男性患者骨质疏松认知普遍不足，尤其在经济弱势群体中更为突出，临床医生应将骨健康教育纳入常规随访，并针对患者社会经济学特征提供个体化指导。摘要Men with prostate cancer (PC) are at increased risk of fragility fractures due to age, the disease itself, and cancer treatment, such as androgen-deprivation therapy. Despite the burden of fragility fractures on individuals and the healthcare systems, preventative measures are poorly implemented for this patient population. This study aims to explore osteoporosis knowledge, health beliefs, and sel...查看完整摘要 6. Anti-C5a antibody STSA-1002 for patients with acute respiratory distress syndrome due to viral pneumonia: a phase 1b/2, multicenter, randomized, double-blind, placebo-controlled trial. [Pneumonia] Chest | 2026-05-16 | IF 9.5 AISTSA-1002在ARDS治疗中展现良好安全性和潜在疗效，1350mg剂量组28天死亡率显著降低（5.88% vs 40%），可能成为ARDS治疗的新选择。摘要ARDS constitutes a major cause of mortality with limited therapeutic options. Whether STSA-1002 is safe and clinically beneficial in ARDS due to viral pneumonia. We conducted a phase 1b/2, multi-center, double-blind, placebo-controlled trial. Participants aged between 18 and 85 years, suffering from ARDS due to viral pneumonia, with PaO2/FiO2 ≤ 200mmHg, were included. Patient...查看完整摘要 7. Immune cell disorder in viral pneumonia. [Pneumonia] 综述 | Journal of translational medicine | 2026-05-16 | IF 6.1 AI监测细胞因子风暴和免疫细胞功能状态对于早期识别重症病毒性肺炎、制定免疫调节治疗策略及改善患者预后至关重要。摘要In recent years, the complexity of viral infections has escalated, leading to a steady rise in the number of patients suffering from viral pneumonia. Both innate and adaptive immune cells play a crucial role in the development and clinical presentation of this condition. Viruses not only initiate the antiviral immune response within the human body but also provoke uncontrolled inflammatory reactio...查看完整摘要 8. Impact of IL-4/IL-13 Blockade with Dupilumab on the Microbiome in Type 2 Inflammatory Diseases: A Systematic Review. [Asthma] 系统综述 | Current allergy and asthma reports | 2026-05-16 | IF 5.4 AI度普利尤单抗可改善皮肤和鼻窦部位微生物组紊乱，微生物组检测有望成为评估2型炎症性疾病治疗效果的辅助指标。摘要To systematically review current evidence on microbiota changes associated with dupilumab treatment across different anatomical sites in type 2 inflammatory diseases. Fifteen studies were included, comprising two randomized trials and thirteen observational studies, mostly in atopic dermatitis, with fewer data in chronic rhinosinusitis with nasal polyps and NSAID-exacerbated respiratory disease. T...查看完整摘要 9. Correction: Understanding Biologics in CRSwNP: Related Events and Insights. [Asthma] Published Erratum | Current allergy and asthma reports | 2026-05-16 | IF 5.4 AI该更正文章强调了生物制剂治疗CRSwNP时需关注的不良事件和临床决策要点，提醒临床医生在选择生物制剂时应权衡获益与风险。 10. C/EBPγ interacts with C/EBPα and activates the β-catenin pathway in idiopathic pulmonary fibrosis. [Idiopathic Pulmonary Fibrosis] Cellular and molecular life sciences : CMLS | 2026-05-15 | IF 6.2 AIC/EBPγ可能成为IPF治疗的新靶点，通过抑制其表达或阻断C/EBPγ/C/EBPα相互作用有望延缓纤维化进程。摘要Idiopathic pulmonary fibrosis (IPF) is a progressive and fatal interstitial lung disease characterized by an abnormal epithelial‒mesenchymal transition (EMT) and fibroblast activation, although the molecular mechanisms driving these processes remain unclear. Here, we report that the expression of CCAAT enhancer binding protein γ (C/EBPγ), a transcription factor, is significantly upregulated in lun...查看完整摘要 11. Elastance as a determinant of the effect of prone positioning on mortality in acute respiratory distress syndrome: a post hoc analysis of the PROSEVA trial. [Respiratory Distress Syndrome] Critical care (London, England) | 2026-05-16 | IF 8.8 AI对于中重度ARDS患者，基线呼吸系统弹性并非预测俯卧位获益的有效指标，临床不应以弹性高低作为俯卧位治疗的筛选依据。摘要Patient factors determining the benefit of prone positioning remain uncertain, resulting in the maneuver being applied indiscriminately among those with moderate-severe ARDS. We aimed to assess if baseline respiratory system elastance (Ers), or "stiffness", determines the treatment effect of prone positioning on mortality. Bayesian logistic regression modeling of the PROSEVA Trial was used to esti...查看完整摘要 12. Postoperative delirium in hip fracture patients linked to epigenetic alterations in inflammatory and immune pathways: a genome-wide DNA methylation study. [Delirium] Translational psychiatry | 2026-05-16 | IF 5.8 AIPOD患者术后早期出现的炎症和免疫相关DNA甲基化改变具有一过性特征，可能成为术后谵妄早期诊断的表观遗传学生物标志物。摘要Delirium is a common yet underdiagnosed condition in elderly hospitalized patients. The lack of effective diagnostic and therapeutic methods can be attributed to the limited understanding of its pathophysiology. Delirium has recently been reported to be linked to neuroinflammation and epigenetic changes. The aim of this study was to validate the pathways in a larger cohort with a uniform type of s...查看完整摘要 13. Gut‑brain axis in anesthesia and critical illness: Molecular crosstalk and its impact on delirium and outcome (Review). [Sepsis] 综述 | International journal of molecular medicine | 2026-05-15 | IF 5.7 AI围术期肠道管理可能是预防术后谵妄的新靶点，维持肠黏膜屏障完整性有望改善危重症患者认知预后。摘要The gut‑brain axis (GBA) has emerged as a critical mediator of acute brain dysfunction, particularly postoperative delirium and sepsis‑associated encephalopathy, in surgical and critically ill patients. Anesthesia, surgical stress, and critical illness collectively disrupt gut microbiota composition and intestinal barrier integrity, leading to increased systemic translocation of microbial products...查看完整摘要 14. Neonatal intensive care unit exposures reprogram microbiome-metabolome trajectories and modulate host calprotectin in preterm infants: a longitudinal multi-omics study. [Sepsis] NPJ biofilms and microbiomes | 2026-05-14 | IF 9.2 AI在早产儿管理中应审慎使用抗生素，优先考虑母乳喂养以保护肠道厌氧菌和聚胺代谢，从而促进正常免疫成熟、降低NEC和败血症风险。摘要Early-life gut microbiota development is critical for orchestrating mucosal barrier function and immune priming, as disruptions in this process can increase susceptibility to life-threatening diseases such as necrotizing enterocolitis (NEC) and sepsis. This longitudinal multi-omics study of 186 preterm infants (<32 weeks of gestation or <1500 g birth weight) explores the impact of early-life expos...查看完整摘要 15. Betrixaban activates cGAS-STING to promote antitumor immunity without pathological inflammation. [Sepsis] EMBO molecular medicine | 2026-05-14 | IF 9.0 AI贝曲沙班可能成为增强免疫治疗效果并减轻免疫相关不良反应的潜在候选药物，为优化癌症免疫治疗策略提供了新思路。摘要Effective cancer immunotherapy requires enhancing tumor-targeted immune responses while limiting pathological inflammation, highlighting an urgent need for single agents that can achieve this balance. Here, we reported that Betrixaban (BT), an FDA-approved Factor Xa inhibitor, functioned as a dual immunomodulator that enhanced antitumor immune responses and suppressed hyperinflammation. BT enhance...查看完整摘要 16. siRNA JNJ-73763989 decreases HBsAg and HDV RNA in NA-treated hepatitis D patients but may cause ALT flares. [Hepatitis B] Journal of hepatology | 2026-05-16 | IF 26.8 AIHBsAg靶向siRNA对CHD患者有抗HDV活性，但高病毒血症患者可能发生ALTflare，需密切监测肝功能。摘要HDV requires HBsAg for viral assembly. The siRNA JNJ-73763989 (JNJ-3989) targets all HBV transcripts and reduces HBsAg in CHB patients. We evaluated whether HBsAg reduction with JNJ-3989 leads to decline of HDV RNA and ALT in patients with chronic hepatitis D (CHD). REEF-D, a 2-part, phase 2, randomized, double-blind, placebo-controlled study, enrolled 22 adults with CHD in Part-1. Participants we...查看完整摘要 17. Pharmacological restoration of impaired autophagy in retinal ganglion cells prevents abnormal mitochondrial accumulation and glaucomatous neurodegeneration. [Glaucoma] Molecular neurodegeneration | 2026-05-16 | IF 14.9 AI即使眼压控制良好，青光眼患者仍可能发生神经退行性变，自噬增强治疗或可成为保护视功能的新靶点。摘要Progressive loss of retinal ganglion cells (RGCs) and degeneration of optic nerve (ON) axons are the key pathological hallmarks of glaucoma, the leading cause of irreversible blindness. Elevated intraocular pressure (IOP), primarily due to dysfunction of the trabecular meshwork (TM), remains the most significant and only known modifiable risk factor. However, vision loss persists in some patients ...查看完整摘要 18. Tau T205 phosphorylation modulates engram cell recruitment and remote memory in mice. [Dementia] Nature communications | 2026-05-16 | IF 14.7 AITau蛋白T205位点磷酸化是远程记忆形成的关键调控节点，病理性tau诱导的异常神经活动可能是tau相关痴呆患者记忆障碍的潜在机制。摘要Memory loss is linked to failure of the engram, the physical substrate associated with a specific memory. Tau is a microtubule associated protein best known for its central role in neurodegenerative dementias, yet its physiological function in memory formation remains poorly understood. In this work, we show that tau is crucial for forming long lasting memories in mice. Site-specific tau phosphory...查看完整摘要 19. Dysfunction of a SET3-like complex underlies a family of related neurological disorders. [Neurodevelopmental Disorders] Nature communications | 2026-05-16 | IF 14.7 AISET3C复合物功能障碍可能是多种神经发育障碍的共同机制，提示相关基因突变检测和靶向干预策略具有潜在临床价值。摘要TBLR1 is a subunit of the NCoR corepressor complex that is mutated in a range of neurodevelopmental disorders. Here, we report that TBLR1 functions as a molecular scaffold that physically connects ANKRD11 and SETD5 - two of the most frequently mutated proteins in neurodevelopmental disorders - and links them to the rest of the NCoR complex. The resulting assembly resembles the yeast SET3 complex (...查看完整摘要 20. Trends and projections of the melanoma burden in G20 countries: A comprehensive analysis from the Global Burden of Disease Study, 1990-2023. [Melanoma] Journal of the American Academy of Dermatology | 2026-05-16 | IF 12.8 AI黑色素瘤在G20国家呈持续增长态势，亚洲地区增速尤为显著，临床医生应加强高危人群早期筛查与防晒健康教育。在小程序获取完整功能收藏文章、管理订阅、查看本期完整摘要与个性化内容，请前往小程序「医研日新」。前往小程序查看更多内容免责声明：仅供学术交流参考，不构成任何医学建议或诊疗指导

临床研究基因疗法

2026-01-03

·医疗资源共享综合服务平台

【IRAK4/BTK双激酶抑制剂XS-04】→ 招募经治套细胞淋巴瘤、弥漫大B细胞淋巴瘤、慢淋/小淋等B细胞淋巴瘤患者进行中

项目简介本临床药物为IRAK4/BTK双激酶抑制剂；目前招募经现有治疗手段治疗失败且无合适治疗的成熟B细胞淋巴瘤【套细胞淋巴瘤（MCL）、弥漫大B细胞淋巴瘤（DLBCL）、慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）、滤泡性淋巴瘤（FL）、边缘区淋巴瘤（MZL）】患者；排除存在淋巴瘤/白血病侵犯中枢神经系统（CNS）的患者；全国多中心。实验名称及药物一项多中心、开放、单臂I期剂量递增和剂量扩展临床研究：评价XS-04片在复发或难治性血液系统恶性肿瘤患者中的安全性、耐受性、药代动力学特征及初步有效性。 XS-04片是星盛新辉自主开发的一款小分子抗肿瘤药物，为IRAK4/BTK双激酶抑制剂，拟用于治疗晚期恶性血液瘤，尤其是以弥漫性大B细胞淋巴瘤（DLBCL）为主的B细胞淋巴瘤。该药能同时抑制IRAK4和BTK两种激酶。临床前研究显示，该新药在多种血液肿瘤模型（包括DLBCL）中展现出较为显著的抑制肿瘤生长的药效且安全性良好，有望解决既往BTK共价抑制剂治疗并产生耐药的问题。研究药物：XS-04片（I期）登记号：CTR20244291 试验类型：单臂试验适应症：复发或难治性血液系统恶性肿瘤（二线及以上）申办方：江苏星盛新辉医药有限公司用药周期 XS-04片的规格：0.5mg、5mg、20mg；用法用量：口服给药，每日2次，剂量组为1 mg、3 mg、10 mg、20 mg、40 mg、80 mg、120 mg、160 mg/日。用药时程：每28天为1个治疗周期，持续给药直至出现疾病进展、不可耐受的毒性、撤回知情同意、死亡或研究结束。主要入选标准 1、自愿参加临床试验，并签署知情同意书（ICF）。 2、年龄≥18周岁，≤75岁，不限性别。 3、剂量递增阶段：按2017年WHO分类标准，组织病理确诊的成熟B细胞恶性肿瘤患者，经现有治疗手段治疗失败且无合适治疗者且具有治疗指征。剂量扩展阶段：按2017年WHO分类标准，组织病理确诊的B细胞淋巴瘤患者（队列一纳入DLBCL患者，队列二纳入其他B细胞淋巴瘤患者），以及按2016 年WHO分类，确诊的髓系肿瘤患者（队列三纳入AML、MDS患者）；符合以下疾病特定标准（以下没有列出的瘤种，将由申办者和研究者共同讨论后决定能否入组）： a. 对于惰性B-NHL（滤泡淋巴瘤、边缘区淋巴瘤和华氏巨球蛋白血症），要求既往接受过至少2线全身治疗且至少1线含抗CD20抗体的联合治疗方案；对于慢性淋巴细胞白血病/小淋巴细胞淋巴瘤，要求既往接受过至少2线全身治疗，包括BTK抑制剂或BCL-2抑制剂；对于MCL，要求既往接受过至少2线全身治疗（包括抗CD20抗体、BTK抑制剂等治疗方案）；对于侵袭性B-NHL（DLBCL），要求既往接受过至少2线全身治疗失败或复发，且不适合接受造血干细胞移植者。 b. 对于AML，根据 2016 年WHO分类确诊的AML，符合《中国复发难治性急性髓系白血病诊疗指南（2021年版）》复发难治的定义：a) 复发性AML：CR后外周血再次出现白血病细胞或骨髓中原始细胞≥5%（除外巩固化疗后骨髓再生等其他原因）或髓外出现白血病细胞浸润；b) 难治性AML：经过标准方案治疗2个疗程无效的初治病例；CR后经过巩固强化治疗，12个月内复发者；在12个月后复发但经过常规化疗无效者；2次或多次复发者；髓外白血病持续存在者。 c. 对于MDS，存在病理确诊的符合WHO 2016分类标准的MDS；且预后积分系统评估为中高危患者（IPSS-R评分＞3），复发难治：a) 复发性 MDS：根据IWG 2006疗效评估标准，在获得完全缓解或部分缓解或血液学改善后，至少出现下列1项：①骨髓原始细胞回升到治疗前水平；②中性粒细胞或血小板计数较最佳疗效下降超过50%；③血红蛋白下降超过15g/L或依赖输血；b) 难治性 MDS：去甲基药物治疗至少4周期未获得缓解；去甲基药物治疗期间发生疾病进展的患者；或对去甲基药物治疗不耐受的患者。 4、B细胞淋巴瘤患者必须存在至少1个影像学可测量病灶（即长径 [LDi]>1.5 cm的淋巴结，LDi>1.0 cm的淋巴结外病灶）。 5、患者须愿意接受骨髓穿刺和/或骨髓活检。 6、美国东部肿瘤协作组（Eastern cooperative oncology group，ECOG）评分剂量爬坡阶段0-1分；剂量扩展阶段0-2分。 7、预期生存时间≥3个月。 8、对于成熟B细胞恶性肿瘤，在筛选期，根据当地实验室参考范围，有足够的不依赖于生长因子支持的骨髓，参考范围如下：a.中性粒细胞绝对计数（ANC）≥1.0×109/L（根据研究者的意见，由于淋巴瘤骨髓浸润导致中性粒细胞<1.0×109/L的患者可以入组）；b.血小板≥75×109/L（剂量爬坡阶段），血小板≥50×109/L（剂量扩展阶段），在首次给药前14天内未输血；c.血红蛋白≥80 g/L。对于AML白细胞计数（WBC）需≤20×109/L（允许服用羟基脲降白细胞治疗）。 9、有适当的器官功能，首次给药前7天内的实验室检查符合以下要求：a肝功能：血清天门冬氨酸氨基转移酶（AST）、丙氨酸氨基转移酶（ALT）≤2.5×ULN，总胆红素≤1.5×正常值上限（ULN）；如果有肝脏侵犯，则AST、ALT≤5×ULN；总胆红素≤3×ULN；b.肾功能：血清肌酐≤1.5×ULN 或依据 Cockcroft-Gault 公式（见附录5）估算的肌酐清除率≥50 mL/min；c.凝血功能：国际标准比值（INR）或凝血酶原时间（PT）≤1.5×ULN；活化部分凝血时间（aPTT）≤1.5×ULN。 10、筛选期育龄期女性患者在首次给药前7天内血清妊娠试验检查结果呈阴性。患者并同意自签署知情同意书至最后一次给药后3个月内使用可靠的方法避孕。包括但不限于：禁欲、男性接受输精管切除术、女性绝育手术、有效的宫内节育器、有效的避孕药物。 11、患者能够遵守研究程序和方案规定的访视。主要排除标准 1、伯基特淋巴瘤/白血病、浆细胞骨髓瘤、浆母细胞淋巴瘤。 2、急性早幼粒细胞白血病（APL）或BCR-ABL阳性的AML患者或既往有骨髓增殖性疾病（MPN）病史。 3、首次接受研究药物前14天内或5个半衰期之内使用过其他细胞毒性药物、研究药物或其他抗肿瘤药物（以较短者为准）（羟基脲和白细胞分离术除外）。首次接受研究药物前4周内接受过肿瘤免疫治疗、抗体类、多肽类抗肿瘤药物治疗的患者。 4、首次接受研究药物前4周内接受过除诊断、活检、引流术外的其他治疗性手术，或预期将在研究期间接受重大手术的患者。对于接受研究药物前4周内进行过引流术（如胸腔、胆道等）和/或放置引流管的患者，要求相关症状/体征已基本缓解，无需预防性/治疗性使用抗生素。 5、首次接受研究药物前4周内接受过系统性放疗。 6、既往抗肿瘤治疗的毒性反应尚未恢复（> NCI-CTCAE 5.0 1级），脱发、色素沉着、神经毒性或其他经研究者评估已转为慢性且不影响研究用药安全性的毒性恢复到NCI-CTCAE 5.0 2级或以下允许入组）。 7、既往接受过异体干细胞移植；首次接受研究药物前3个月内（成熟B细胞恶性肿瘤患者）或6个月内（AML、MDS患者）接受过自体干细胞移植或过继免疫细胞治疗。 8、存在淋巴瘤/白血病侵犯中枢神经系统（CNS）的患者。 9、吞咽困难，或者有严重胃肠道疾病史（如活动期炎症性肠病、胃肠道穿孔）且相关症状无法合理控制的患者；或有影响药物吸收的胃肠道疾病（如克罗恩病、溃疡性结肠炎、肠梗阻、短肠综合征）或其他吸收不良情况。 10、眼部结膜、角膜病变患者（经治疗眼部病变痊愈后可入组）。 11、患有活动性或不稳定的心脑血管疾病，包括但不限于：a.需要临床干预的严重的心脏节律或传导异常；b.首次给药前6个月内发生急性冠脉综合征、充血性心力衰竭、心肌梗死、不稳定型心绞痛、冠状动脉/外周动脉旁路移植术、脑梗死、脑出血、肺栓塞、深静脉血栓形成（首次给药前3个月内）或其他严重心血管事件；c.美国纽约心脏病协会（NYHA，见附录4）心功能分级≥II级；d.左室射血分数（LVEF）＜50%；e.存在尖端扭转型室性心动过速、先天性长QT综合征；f.静息状态下，3次心电图平均QTcF＞450ms（男性）或＞470ms（女性）；g.尽管接受了最佳治疗，无法控制的高血压（定义为在药物控制情况下，收缩压≥160 mmHg 或舒张压≥100 mmHg）。 12、有间质性肺病（ILD）、肺间质纤维化病史；或筛选期胸部CT扫描发现活动性肺炎证据。 13、患有先天性免疫缺陷疾病，或活动性自身免疫性疾病，包括但不限于患有活动性且无法控制的自身免疫性血细胞减少症，持续2周或更长时间，包括自身免疫溶血性贫血和特发性血小板减少性紫癜。 14、患有凝血障碍性疾病（例如血友病）。 15、正在使用抗凝药物。其抗凝药物包括华法林、达比加群、利伐沙班、阿哌沙班、艾多沙班、贝曲沙班、普通肝素、低分子肝素、依诺肝素、达肝素以及那屈肝素、比伐卢定及阿加曲班。 16、既往有严重过敏史者，或对研究药物的任何活性或非活性成分过敏者。 17、研究药物首次给药前两周内存在未控制的全身感染（病毒、细菌、真菌）；乙肝表面抗原阳性且乙型肝炎病毒DNA超过1000 IU/ml；丙肝病毒（HCV）抗体阳性或 HCV RNA 阳性；人类免疫缺陷病毒（HIV）抗体阳性。 18、患有其他原发性恶性肿瘤，以下情况可以入组：治愈且完全切除的基底细胞和鳞状细胞皮肤癌、完全切除的任何类型的原位癌。 19、研究用药前2周内仍需要继续使用全身免疫抑制剂或全身性皮质类固醇（≥10mg强的松或其当量的其它皮质类固醇）者。 20、首次给药前2周内使用过CYP3A强抑制剂或强诱导剂。 21、妊娠期、哺乳期妇女。 22、根据研究者判断，其它任何严重或未控制的急慢性疾病或实验室检查异常或存在其他原因不适合参加本临床研究。研究中心北京河北保定广东广州湖北武汉河南郑州吉林长春辽宁沈阳天津浙江杭州参加临床试验的获益 1、获得先进治疗机会临床试验通常涉及尚未上市的新药物、新疗法或新技术，这些治疗方案可能代表医学领域的前沿突破。对于一些难治性疾病（如晚期癌症、罕见病等），患者可能通过临床试验接触到比现有标准治疗更有效、副作用更小的方案，从而延长生存期、改善生活质量。 2、减轻经济负担参与临床试验期间，患者通常可免费获得试验药物、相关检查及部分医疗费用支持。对于需要长期治疗且药物价格高昂的患者（如肿瘤患者），这能显著减轻家庭经济压力，使患者更易坚持规范治疗。 3、专业医疗照护与监测临床试验由专业医疗团队主导，患者会接受更频繁、更全面的病情监测和随访。医生会密切关注身体反应，及时调整治疗方案，确保患者安全。这种精细化的医疗管理有助于更好地控制病情，发现潜在问题并及时处理。 4、推动医学进步患者的参与为新药研发和医学研究提供了关键数据，有助于验证新疗法的安全性和有效性。每一份数据都可能为未来更多患者的治疗带来希望，患者因此成为医学进步的贡献者，获得参与科学探索的成就感。 5、个性化治疗探索部分临床试验聚焦于特定基因特征或疾病亚型，患者可能通过试验获得更精准的个性化治疗方案。这种针对性治疗可能提高疗效，减少不必要的治疗尝试。 6、需注意，临床试验存在一定不确定性，疗效和安全性需结合个体情况评估。患者在参与前应与医生充分沟通，了解试验细节、风险和潜在获益，自主决定是否参与。总结归纳： 1、免除项目用药：研究药物使用，直至疾病进展。 2、免除项目检查：签署知情后试验所需相关检查。 3、项目交通补助：临床研究相关的交通补助。 4、专家定期随访：全程专家团队服务，一对一随访。 5、全程绿色就医通道：减少预约和排号时间，减少就医流程。报名资料收集肿瘤患者需要准备和提交的资料包括： 1、首次确诊时的出和入院记录、病理免疫组化报告、基因检测报告(含PDL-1）、影像报告（心电图、超声检查、CT/MRI检查、PET/CT、影像胶片）、血常规、肝肾功能、凝血功能、传染病检查、肿瘤标志物、心电图报告等。 2、肿瘤患者经过一线治疗过的，还需要提供末次治疗时的出和入院记录、如有二次做的病理免疫组化报告、基因检测报告、最新的影像报告（心电图、超声检查、CT/MRI检查、PET/CT、影像胶片）、血常规、肝肾功能、凝血功能、传染病检查、肿瘤标志物、心电图报告等。如果您或您的周围有满足以上条件的患者，可以与我们联系。该研究遵从相关的国家法规，患者的隐私权亦会得到保护。想了解该项目的具体信息，请咨询以下联系方式。 ■ 如果您有意向参加此研究，可通过如下方式咨询：目前我们有食管癌、胃癌、肝癌、胰腺癌、胆道癌、直肠癌、乳腺癌、卵巢癌、宫颈癌、子宫内膜癌、膀胱癌、前列腺癌、肺癌、黑色素瘤、头颈鳞癌、淋巴瘤、白血病、骨髓瘤、高血压、糖尿病、青光眼、哮喘、红斑狼疮、荨麻疹、斑秃、皮炎、减肥等项目同期进行中...... 免责声明： 1，本公众号发布为提供信息，不构成任何建议。 2，本公众号所刊发、转载的文章，其观点、内容、字体、图片版权均归原作者所有，相关责任作者自负。

2025-12-05

·PipelineReview

Tr1X, Inc. Announces $75 Million Series A Financing to Develop Best-in-Class Universal Allogeneic Regulatory T (Treg) and CAR-Treg Cell Therapies to Treat and Potentially Cure Autoimmune and Inflammatory Diseases

SAN DIEGO, CA, USA I January 17, 2024 I Tr1X, Inc. today announced its emergence from stealth with a $75 million Series A financing to bring universal allogeneic regulatory T (Treg) and CAR-Treg cell therapies to the clinic to treat and potentially cure autoimmune and inflammatory diseases. The financing was led by Bay Area-based The Column Group, with participation from NEVA SGR and Alexandria Ventures. The Company appointed William Lis Chief Executive Officer, strengthened its leadership team with other biopharma industry veterans, and announced members of the Board of Directors and Scientific Advisory Board. "We are thrilled to partner with Bill Lis, Maria Grazia Roncarolo and Tr1X's world-class team to revolutionize the field through its innovative, breakthrough science," said Leon Chen, Ph.D., MBA, Partner at The Column Group and Tr1X Board Member. "With its experienced management team at the helm, we are confident in Tr1X's ability to bring curative cell therapies to patients who currently require life-long treatment and management." Science and Pipeline The Company's science is primarily based on the work of Tr1X's Scientific Founder Maria Grazia Roncarolo, M.D., the discoverer of Type 1 regulatory T (Tr1) cells, which have features that can benefit patients with autoimmune and inflammatory diseases. Tr1 cells, a differentiated subpopulation of regulatory T cells, are crucial for maintaining homeostasis and tolerance in healthy individuals and have several important functions. These include dampening of local inflammation and downregulation of the inflammasome, suppression of pathogenic effector T cell responses, and induction of long-term tolerance as observed in preclinical models and patients. Tr1X's proprietary technology enables the conversion of CD4 + T cells isolated from healthy donors into Treg-like cells that have a similar function and profile to naturally occurring Tr1 cells. These cells can be further engineered to target specific tissues or organs to enable local, targeted immunomodulation. With a proprietary, GMP-grade, closed-loop system that provides consistency, quality and reliability at scale, Tr1X can enable production of its products at commercial volume. Currently, Tr1X is working on its first investigational Tr1 cell therapy, TRX103, which it plans to evaluate in a Phase 1 trial to prevent Graft versus Host Disease (GvHD) in patients undergoing mismatched hematopoietic stem cell transplant. The Company is developing additional pipeline programs to treat inflammatory bowel disease, Type 1 diabetes and multiple B-cell mediated autoimmune diseases. "The ability to develop a pipeline of medicines based on our work on regulatory T cells represents the culmination of decades of discovery and research into the underpinnings of immunological tolerance and autoimmunity," said Dr. Roncarolo, Scientific Founder, President and Head of R&D at Tr1X. "Tr1 cells have unique properties and represent the ideal therapeutic platform from which to develop 'immune reset' products. Our two platforms have the required attributes to address a broad set of indications, including dual targeting of pathogenic T and B cells. These engineered cells have the potential to induce tolerance, which could transform the lives of people living with chronic autoimmune diseases by providing them with a cure instead of ongoing treatment." Proven Leadership Team, Board of Directors and Scientific Advisory Board Tr1X is led by industry veterans with cell therapy expertise who have a track record of discovery, development and commercialization of more than a dozen novel first- or best-in-class medicines. Chief Executive Officer William "Bill" Lis has more than 25 years of biotech executive leadership experience in building companies and product pipelines from R&D stage through commercialization. He most recently served as Chairman and interim CEO of Jasper Therapeutics, Inc., from 2019 to 2022, where he led the company's Series A and follow-on financings and successful brequilimab Phase 1 study readouts in hematopoietic stem cell transplantation. Before that, he served as Chief Executive Officer and a Director of Portola Pharmaceuticals, Inc. from 2008 to 2018 after serving as Chief Operating Officer, where he built the company from a private research-stage startup into a multi-billion dollar public company that launched Andexxa ® and Bevyxxa ® . Portola was acquired by Alexion Pharmaceuticals, Inc. in 2020. Previously, Mr. Lis held executive positions at Scios, Inc. (a Johnson & Johnson company) where he last served as Senior Vice President of New Product Development and Business Development, leading in-licensing efforts, development and commercial P&L operations for Xarelto ® and the company's therapeutics pipeline. Earlier in his career, he held positions at Millennium Pharmaceuticals, Inc., COR Therapeutics, Inc. and Rhone Poulenc Rorer. He is a director of Zai Laboratories, Inc. Scientific Founder, President and Head of R&D Dr. Maria Grazia Roncarolo is the George D. Smith Professor in Stem Cell and Regenerative Medicine, Professor of Pediatrics and Medicine, Founder of the Center for Definitive and Curative Medicine, and former Co-Director of the Institute for Stem Cell Biology and Regenerative Medicine at Stanford University. Dr. Roncarolo has spent her career translating discoveries in immune-mediated diseases and regenerative medicine into novel patient therapies. She and her team were the first to discover Type 1 regulatory T cells in patients and the first to develop curative treatments for ADA-SCID. A pediatric immunologist by training, she was instrumental in bringing novel cell and gene therapies to market, including Strimvelis ® and Libmeldy ® . She is a Co-Founder of the gene-editing companies Graphite Bio and Kamau Therapeutics. Co-Founder and Chief Operating Officer David de Vries has over a decade of experience founding and scaling companies at the intersection of healthcare, biology and technology. Prior to Tr1X, he was Co-Founder and Chief Operating Officer of Arine, a medication intelligence and therapeutic optimization company he helped start, launch and scale to serve millions of patients, working with some of the largest healthcare organizations in the U.S. Previously, he worked at Proteus Digital Health, an innovative drug-device company and the first in the field to obtain FDA approval for a digital medicine, Abilify MyCite ® . "Tr1X is committed to bringing cures to millions of patients suffering from autoimmune diseases through our scalable, universal allogeneic cell therapy process that has been demonstrated to yield billions of cells in a single run," said Mr. Lis, CEO of Tr1X. "In just 18 months, the Tr1X team has successfully closed a Series A financing and extension, assembled an experienced leadership team, board of directors and scientific advisory board, and established a scalable GMP-grade manufacturing process. We are well positioned to advance our pipeline of first-of-their kind allogeneic engineered Treg and CAR-Treg cell therapies that have the potential to address the significant limitations of current cell therapies for autoimmune diseases, which include, among others, poor trafficking, lack of stability, limited persistence and induction of cytokine-associated toxicities, at a fraction of the cost per dose." In addition to Mr. Lis, Dr. Roncarolo and Mr. de Vries, the Tr1X leadership team includes Xavier Paliard, Pharm.D., Ph.D., Chief Scientific Officer; James Adams, MBA, Chief Technical Officer; Jonathan Perrin, J.D., Co-Founder and General Counsel; and Erik Poulsen, M.S., Head of Regulatory Affairs. Joining Mr. Lis and Dr. Roncarolo on Tr1X's Board of Directors are: Tr1X has recruited experts in immunology, stem cell and gene therapy, T-cell biology and immune-mediated diseases to join its Scientific Advisory Board. They include: About Tr1X Tr1X is a privately held biotechnology company focused on engineering cures for immune and inflammatory diseases. Founded by industry veterans, including the scientists behind the discovery of Tr1 cells, the company's pipeline of universal allogeneic cell therapies is being developed for diseases with high unmet medical need. The company is headquartered in San Diego, has developed a robust intellectual property portfolio, and is backed by leading investors, including The Column Group, NEVA SGR and Alexandria Ventures. For more information visit: www.tr1x.bio . SOURCE: Tr1X

细胞疗法高管变更临床1期免疫疗法基因疗法融资

100 项与贝曲沙班相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D08873	贝曲沙班	B01AF	DB12364

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
血栓栓塞	美国	Portola Pharmaceuticals LLC	2017-06-23
静脉血栓栓塞	美国	Portola Pharmaceuticals LLC	2017-06-23

未上市

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适应症	最高研发状态	国家/地区	公司	日期
出血	临床2期	美国	Portola Pharmaceuticals LLC	2015-08-06
心房扑动	临床2期	-	Portola Pharmaceuticals LLC	2010-09-01
心房颤动	临床2期	美国	Portola Pharmaceuticals LLC	2008-10-01
心房颤动	临床2期	加拿大	Portola Pharmaceuticals LLC	2008-10-01

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临床结果

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


NCT03346083 (CTgov)	临床1期	静脉血栓栓塞	21	Betrixaban (Cohort 1: Betrixaban 40 mg)	鑰壓艱製鑰醖淵憲齋鹹(淵構蓋壓構繭齋淵願膚) = 艱遞壓簾構憲鏇築憲鹹餘壓艱鏇襯願觸衊艱窪 (窪範鏇糧窪夢襯網窪衊, 鏇築淵膚憲餘鏇糧網膚 ~ 鑰淵憲鹹鏇構網鹽繭齋) 更多	-	2024-01-12
				Betrixaban (Cohort 2: Betrixaban 80 mg)	鑰壓艱製鑰醖淵憲齋鹹(淵構蓋壓構繭齋淵願膚) = 製壓選糧繭廠襯築顧鏇餘壓艱鏇襯願觸衊艱窪 (窪範鏇糧窪夢襯網窪衊, 選艱範淵構鑰艱廠廠鏇 ~ 廠顧選鏇蓋簾範鹹築構) 更多
NCT03330457 (CTgov)	临床2期	出血	18	Andexanet alfa (bolus)+Betrixaban 80 mg PO QD (Cohort 1 Bertrixaban/Andexanet)	艱鏇願選願遞獵壓遞醖(膚膚觸襯觸膚窪積獵淵) = 鏇蓋艱蓋鏇廠夢膚積構艱襯積廠憲齋築獵願構 (製願願築鹹鹽淵齋蓋鹹, 7.453) 更多	-	2020-08-19
				Andexanet alfa (bolus)+Betrixaban 80 mg PO QD (Cohort 1 Bertrixaban/Placebo)	艱鏇願選願遞獵壓遞醖(膚膚觸襯觸膚窪積獵淵) = 廠淵顧壓糧選蓋願選壓艱襯積廠憲齋築獵願構 (製願願築鹹鹽淵齋蓋鹹, 10.090) 更多
NCT02111564 \| NCT00571649 \| NCT01583218 (Pubmed \| Crit Pathw Cardiol)	临床3期	急性疾病	-	Betrixaban or Rivaroxaban	艱蓋憲衊窪觸鬱壓醖構(範遞夢築夢膚廠鏇願醖) = 積夢衊範製艱顧鹽鹹願憲壓顧願窪簾鬱簾顧蓋 (蓋糧築積顧範築製鏇衊, -2.32% ~ -0.69%) 更多	-	2020-07-09
NCT01583218 (APEX, Pubmed \| Intensive Care Med)	临床3期	危重病	7,513	Betrixaban	築齋獵鏇顧積壓襯鹹遞(蓋艱顧鑰鹽獵構獵糧簾) = 蓋鬱構築築範遞範獵襯淵艱憲製蓋製繭遞淵網 (襯窪壓鏇遞網衊衊膚獵 ) 更多	-	2019-04-01
				Enoxaparin	築齋獵鏇顧積壓襯鹹遞(蓋艱顧鑰鹽獵構獵糧簾) = 構製繭顧繭製鹽簾醖餘淵艱憲製蓋製繭遞淵網 (襯窪壓鏇遞網衊衊膚獵 ) 更多
NCT01583218 (APEX, Pubmed)	临床3期	静脉血栓栓塞	7,513	Betrixaban	糧網觸製膚鏇觸遞餘夢(鑰艱製繭觸壓壓顧襯鹽) = 顧襯遞鏇鏇鑰衊糧遞餘衊襯鑰窪膚鬱簾廠網窪 (鏇獵淵繭蓋鏇遞廠襯餘 )	积极	2018-01-01
				Enoxaparin	糧網觸製膚鏇觸遞餘夢(鑰艱製繭觸壓壓顧襯鹽) = 鹹醖襯築餘鹹鏇築製淵衊襯鑰窪膚鬱簾廠網窪 (鏇獵淵繭蓋鏇遞廠襯餘 )
NCT00375609 (CTgov)	临床2期	血栓栓塞	215	Betrixaban (Betrixaban 15 mg)	積網糧選獵鏇鏇淵鏇範 = 鏇蓋餘選鹹淵繭鬱齋蓋醖築襯鏇積夢蓋獵觸範 (淵鏇鏇顧鏇窪鑰窪網醖, 衊製齋襯齋觸淵蓋壓顧 ~ 簾夢範窪艱窪鬱鑰廠膚) 更多	-	2017-12-15
				Betrixaban (Betrixaban 40 mg)	積網糧選獵鏇鏇淵鏇範 = 構餘膚夢醖簾蓋襯艱鹹醖築襯鏇積夢蓋獵觸範 (淵鏇鏇顧鏇窪鑰窪網醖, 簾獵襯鑰醖糧壓獵廠選 ~ 範築鹹壓艱膚鏇襯網膚) 更多
NCT00742859 (EXPLORE-Xa, CTgov)	临床2期	心房颤动	508	Betrixaban (Betrixaban 40 mg)	淵艱蓋艱製齋顧鹹窪壓 = 艱鏇廠鬱鏇範壓獵積鑰鑰衊獵蓋積願蓋鹹繭糧 (簾觸鑰膚窪獵淵糧鏇壓, 艱網膚顧鏇網築顧齋蓋 ~ 製鹽願鏇壓獵選網襯餘) 更多	-	2017-09-26
				Betrixaban (Betrixaban 60 mg)	淵艱蓋艱製齋顧鹹窪壓 = 醖壓鏇齋積簾窪簾構構鑰衊獵蓋積願蓋鹹繭糧 (簾觸鑰膚窪獵淵糧鏇壓, 醖鑰築簾窪鹽鑰構蓋廠 ~ 糧衊選繭淵選窪繭網壓) 更多
NCT01583218 (APEX Trial \| APEX, CTgov)	临床3期	静脉血栓栓塞	7,513	Betrixaban (Betrixaban)	獵願鑰醖獵獵齋夢鹽廠 = 獵構蓋壓鑰衊廠鬱窪製壓遞觸鹽憲製襯糧窪齋 (艱鏇蓋簾鏇蓋餘鹽襯淵, 鑰艱醖齋製選觸衊鹹襯 ~ 鑰鏇醖壓製艱網襯餘膚) 更多	-	2017-09-20
				Enoxaparin (Enoxaparin)	獵願鑰醖獵獵齋夢鹽廠 = 廠鹽簾廠衊夢範壓遞醖壓遞觸鹽憲製襯糧窪齋 (艱鏇蓋簾鏇蓋餘鹽襯淵, 製範網廠壓積構壓襯餘 ~ 鏇鬱鑰醖觸鑰壓壓遞築) 更多
NCT01229254 (CTgov)	临床2期	心房扑动 \| 心房颤动	189	Amiodarone+Betrixaban (Betrixaban 30 mg (+Amiodarone))	範襯齋壓構齋膚醖糧憲(觸蓋糧壓網壓願鹽鹹獵) = 糧獵簾夢鑰鏇醖遞廠鹽壓築衊獵鏇餘選餘鏇鬱 (製廠廠鹽壓願糧鹹艱製, 衊廠襯鑰襯積憲壓襯醖 ~ 艱壓壓醖構簾積壓製壓) 更多	-	2017-09-18
				Betrixaban (Betrixaban 60 mg (<80 kg))	獵繭願窪簾膚觸構繭顧(糧鹽膚構製夢糧壓齋構) = 簾選窪獵廠遞衊鹽鏇醖構構鹽觸壓蓋壓鹽選蓋 (繭憲鬱憲簾膚廠蓋製積, 願醖範範餘鹽鏇艱窪製 ~ 積鹹鏇積網醖膚築襯範) 更多
APEX study (ESC2017)	临床3期	-	-	Betrixaban 80 mg	築衊製鑰廠遞蓋範醖築(衊選膚壓築餘構憲淵夢) = 鹹糧淵遞鬱遞選選膚夢積簾鹽齋齋醖淵選遞繭 (糧鬱廠簾鑰遞遞廠憲壓 )	-	2017-08-29
				Betrixaban 40 mg	築衊製鑰廠遞蓋範醖築(衊選膚壓築餘構憲淵夢) = 淵醖齋壓獵積製網選淵積簾鹽齋齋醖淵選遞繭 (糧鬱廠簾鑰遞遞廠憲壓 )