主要目的：根据总ABR评估ADYNOVATE用于预防性治疗中国重度A型血友病受试者的有效性。次要目的：基于出血部位的ABR和病因，评估ADYNOVATE用于预防性治疗的有效性评估ADYNOVATE用于治疗研究期间非手术突破性出血事件的总体止血有效性评估ADYNOVATE用于围手术期出血管理（如果在研究期间进行小手术）的有效性通过评估AE、严重AE（SAE）以及具有临床意义的生命体征和临床实验室参数结果来评价ADYNOVATE的安全性根据产生FVIII抑制性抗体和ADYNOVATE结合抗体的发生率评价ADYNOVATE的安全性和免疫原性评价ADYNOVATE在中国受试者中的PK

开始日期2023-03-27

申办/合作机构

Baxalta Manufacturing SARL

[+2]

NCT05707351

/ Completed临床3期

A Phase 3, Prospective, Multicenter, Open-label Study of Efficacy, Safety, and Pharmacokinetics of PEGylated Recombinant Factor VIII (ADYNOVATE) Administered for Prophylaxis and Treatment of Bleeding in Chinese Previously Treated Patients With Severe Hemophilia A (FVIII <1%)

The main aim of the study is to determine how well Adynovate works to decrease bleeding in previously treated Chinese men and boys with severe hemophilia A when given prophylactically.
Participants will be treated with Adynovate twice a week for 26 weeks or until participants have received 50 days of treatment with Adynovate (whichever takes longer). Participants will need to visit their study clinic several times during their participation.

开始日期2023-03-27

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

NCT05042440

/ Completed临床1期

A Phase 1, Single-Site, Open-Label Study to Assess Pharmacokinetics of Efanesoctocog Alfa (BIVV001), Standard Half-Life and Extended Half-Life FVIII After Each Single Intravenous Injection in a Fixed Sequence, in Previously Treated Adults With Severe Hemophilia A

Primary objective
• To assess the half-life of BIVV001, Standard Half-Life (SHL) rFVIII and Extended Half-Life (EHL) rFVIII after a single intravenous (IV) injection
Secondary objectives
To characterize additional pharmacokinetic (PK) parameters of BIVV001, SHL rFVIII and EHL rFVIII after a single IV injection
To evaluate the safety and tolerability of a single IV injection of BIVV001

开始日期2021-08-11

申办/合作机构

Sanofi SA

100 项与培重组人凝血因子Ⅷ 相关的临床结果

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100 项与培重组人凝血因子Ⅷ 相关的转化医学

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100 项与培重组人凝血因子Ⅷ 相关的专利（医药）

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项与培重组人凝血因子Ⅷ 相关的文献（医药）

2025-01-01·ADVANCES IN THERAPY

Efanesoctocog Alfa versus Standard and Extended Half-Life Factor VIII Prophylaxis in Adolescent and Adult Patients with Haemophilia A without Inhibitors

Review

作者: Klamroth, Robert ; Kragh, Nana ; Wojciechowski, Piotr ; Margas, Wojciech ; Bystrická, Linda ; Arnaud, Alix ; Wdowiak, Marlena ; Guyot, Patricia ; Wilson, Amanda ; Tosetto, Alberto

INTRODUCTION:

In the Phase 3 XTEND-1 trial, (NCT04161495) efanesoctocog alfa prophylaxis provided superior bleed protection versus pre-study factor VIII (FVIII) replacement therapy in patients with severe haemophilia A. The aim of this study was to indirectly compare bleed outcomes between efanesoctocog alfa and standard/extended half-life (SHL and EHL) FVIII replacement therapies in adolescent and adult patients with severe haemophilia A without inhibitors.

METHODS:

A systematic literature review was conducted to identify Phase 3 trials of EHL and SHL FVIII replacement therapies for comparison with efanesoctocog alfa data from XTEND-1. Matching-adjusted indirect comparisons were used to compare annualised bleeding rates (ABRs) for any, treated, joint, and spontaneous bleeds between efanesoctocog alfa and comparators. The estimates from respective comparisons were pooled using random-effect meta-analyses to evaluate the overall difference between efanesoctocog alfa and comparator therapies.

RESULTS:

Four EHL therapies (rurioctocog alfa pegol, efmoroctocog alfa, turoctocog alfa pegol, damoctocog alfa pegol) and two octocog alfa SHL therapies were included. In meta-analyses, efanesoctocog alfa was associated with significantly lower ABRs for any [mean difference (95% CI) - 2.24 ( - 3.24; - 1.25)], spontaneous [ - 1.52 ( - 2.33; - 0.72)], and joint bleeds [ - 1.60 ( - 2.32; - 0.88)] versus EHL therapies, and with significantly lower ABRs for any [ - 3.61 ( - 4.43; - 2.79)], treated [ - 1.55 ( - 1.89; - 1.20)], spontaneous [ - 2.52 ( - 3.31; - 1.72)], and joint bleeds [ - 3.42 ( - 4.77; - 2.08)] versus SHL therapies.

CONCLUSION:

Efanesoctocog alfa was associated with significantly lower ABRs (any, spontaneous and joint) compared with EHL or SHL prophylaxis therapies. Patients had, on average, 2.2 and 3.6 fewer bleeds per year versus EHL and SHL therapies, respectively.

2024-12-01·Blood Research

Real-world insights into the management of hemophilia A in Italy: treatment patterns and healthcare resource utilization

Article

作者: Cappuccilli, Maria ; Leogrande, Melania ; Perrone, Valentina ; Esposti, Luca Degli

Abstract:

Purpose:

This real-world analysis described the Hemophilia A (HA) population in Italy, evaluating drug utilization and consumption of factor VIII (FVIII) products of patients under prophylaxis and on-demand therapy.

Methods:

From Jan-2017 to Jun-2022, male patients with HA were identified through prescriptions of FVIII products [extended half-life FVIII, standard half-life recombinant FVIII, and plasma-derived FVIII (EHL FVIII, SHL rFVIII, and pdFVIII, respectively)], or emicizumab or FVIII plus von Willebrand factor or HA-related hospitalization using administrative flows of Italian healthcare entities. Patients on treatment with FVIII products during 2021–2022 were stratified by treatment regimen (prophylaxis/on-demand). The mean annual consumption expressed in International Units (IU) of EHL FVIII and SHL FVIII in patients treated during 2021–2022 having at least 12-month follow-up were assessed.

Results:

Among included HA patients, 145 (39.5%) received EHL FVIII and 222 (60.5%) SHL FVIII. Of 165 patients on prophylaxis, 105 (64%) received an EHL FVIII and 60 (36%) an SHL FVIII. The mean annual consumption of FVIII was 336,700 IU (median 319,000 IU) for EHL FVIII and 440,267 IU (median 360,500 IU) for SHL FVIII. Specifically, for patients on EHL FVIII, the most common drugs were efmoroctocog alfa (N = 51) and damoctocog alfa pegol (N = 50), followed by turoctocog alfa pegol (N = 25) and rurioctocog alfa pegol (N = 19). Of 702 HA patients initially treated with FVIII products, 74 (10.5%) switched to emicizumab during follow-up.

Conclusion:

These findings revealed an extensive use of EHL FVIII products, suggesting growing efforts from clinicians to optimize prophylactic strategies and achieve better bleeding protection.

2024-12-01·Blood Research

Evaluation of FVIII pharmacokinetic profiles in Korean hemophilia A patients assessed with myPKFiT: a retrospective chart review

Article

作者: Choi, Eun Jin ; Jung, Aeran ; Hwang, Taiju ; Park, Young-Shil ; Yoo, Ki-Young ; Park, Sang Kyu

Abstract:

Purpose:

This study aimed to investigate the pharmacokinetics (PK) of factor VIII (FVIII) in Korean patients, as limited information is available on the PK of FVIII in this population.

Methods:

We collected the FVIII PK results from patients with moderate-to-severe hemophilia A using myPKFiT. PK variations were assessed according to age, blood type, inhibitor history, von Willebrand factor antigen (vWF:Ag) level, and body mass index. Additionally, the correlation between the PK profile and prophylaxis regimen was specifically analyzed for each product in severe cases.

Results:

The PK data of 48 and 81 patients treated with octocog alfa and rurioctocog alfa pegol, respectively, were obtained. The median half-lives of octocog alfa and rurioctocog alfa pegol were 9.9 (range: 6.3–15.2) h and 15.3 (range: 10.4–23.9) h, respectively. The PK profiles for each product did not differ according to age group; however, blood type-O patients had shorter half-lives and time to 1% compared to non-blood type-O patients. In regression analysis, the PK of octocog alfa showed a statistically significant difference according to age, whereas the PK of rurioctocog alfa pegol correlated with vWF:Ag. Only the frequency of rurioctocog alfa pegol use showed a statistically significant difference in relation to time to 1%, although the coefficient of determination was small.

Conclusion:

This study confirmed significant interpatient variation in the PK of FVIII among Korean patients with hemophilia A. To achieve optimized prophylaxis, personalizing the regimen based on the PK profile of each individual patient is essential.

项与培重组人凝血因子Ⅷ 相关的新闻（医药）

2024-09-06

·SYNAPSE

Grünenthal acquires Valinor for $250 million to obtain an opioid antagonist product

Recently, the German company Grünenthal, specializing in the development of pain relief medications, announced the acquisition of the American pharmaceutical manufacturer Valinor Pharma for $250 million in order to obtain the rights to Movantik (naloxegol), a treatment for opioid-induced constipation developed by Valinor. It is reported that in 2023, sales of this product reached $200 million in the United States. Since Grünenthal already holds the rights to Movantik in the European Union, the acquisition of Valinor will allow Grünenthal to have complete control over the Movantik brand in all markets outside of Canada. The United States is considered the company's most important growth market, and the acquisition of Valinor will strengthen Grünenthal's position in the pain management sector in the U.S. About NaloxegolNaloxegol is a selective peripherally-acting μ-opioid receptor antagonist (PAMORA) and a pegylated form of naloxone. This product was originally developed by Nektar Therapeutics and further developed by AstraZeneca. It was approved by the U.S. FDA in September 2014 for the treatment of opioid-induced constipation in adults with chronic non-cancer pain. Notably, Nektar holds a patent for its drug pegylation technology, and naloxegol's advantage over the opioid receptor antagonist naloxone stems from its pegylated structure, which confers high selectivity for peripheral opioid receptors while not crossing the blood-brain barrier. According to a pharmacological study published in 2017, naloxegol is a potent antagonist at human μ-opioid receptors in vitro, with a Ki value of 7.42 nM, demonstrating an action similar to that of non-PEGylated naloxone. AstraZeneca published the clinical study results of Naloxegol in the New England Journal of Medicine in 2014. Compared to placebo, the use of Naloxegol significantly improved treatment response rates without reducing the analgesic effects mediated by opioids. In addition to Naloxegol, Nektar developed ADYNOVATE in collaboration with Baxter and Baxalta. ADYNOVATE is an extended half-life recombinant Factor VIII (rFVIII) product for the treatment of hemophilia. In January 2019, Takeda Pharmaceutical acquired Shire, gaining ownership of Baxalta and ADYNOVATE as a result. About PEGylated PharmaceuticalsPEGylated pharmaceuticals are composed of various reagents, including linkers, crosslinkers, and labels. Different types of reagents include amine, carboxyl, and carboxyl PEGylation. Currently, PEGylated drugs are primarily used to treat conditions such as cancer, chronic kidney disease, hepatitis, multiple sclerosis, hemophilia, and gastrointestinal diseases. In March 1990, ADAGEN produced by Enzon Pharmaceuticals was the first PEGylated protein approved by the U.S. Food and Drug Administration (FDA) for market entry. Since the launch of ADAGEN, a large number of PEGylated proteins and peptide drugs have followed suit, and many more are in clinical trials or development stages. Among the FDA-approved drugs, Pegasys and Neulasta generated sales exceeding $5 billion in 2011. How to obtain the latest research advancements in the field of biopharmaceuticals? In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!

2023-10-31

·PRNewswire

Octapharma AG: Indirect comparison data indicate that personalised prophylaxis with Nuwiq® may lead to fewer patients with haemophilia A having bleeds than with other recombinant factor VIII products

The well-established matching-adjusted indirect comparison (MAIC) methodology was used to compare the efficacy of personalised prophylaxis with Nuwiq® against other recombinant FVIII products Personalised prophylaxis with Nuwiq® can lead to higher rates of patients with zero bleeds compared with other recombinant FVIII products, albeit with higher weekly doses The data were published recently in the European Journal of Haematology LACHEN, Switzerland, Oct. 31, 2023 /PRNewswire/ -- Data from a matching-adjusted indirect comparison (MAIC) of Nuwiq® (simoctocog alfa) versus extended half-life recombinant factor VIII (rFVIII) concentrates in haemophilia A patients undergoing personalised prophylaxis were published in the European Journal of Haematology1. Preliminary data from the MAIC were presented by Dr Craig Kessler, Lombardi Comprehensive Cancer Center and Georgetown University Medical Center, at the 65th ASH Annual Meeting & Exposition in December 20222. Continue Reading Octapharma AG: Indirect comparison data indicate that personalised prophylaxis with Nuwiq® may lead to fewer patients with haemophilia A having bleeds than with other recombinant factor VIII products The analysis used MAIC – a well-established statistical approach – to compare the efficacy of pharmacokinetic (PK)-guided, personalised prophylaxis with Nuwiq® (simoctocog alfa) versus Eloctate® (efmoroctocog alfa), Jivi® (damoctocog alfa pegol), and Adynovate® (rurioctocog alfa pegol). The analysis used data from prospective clinical trials of personalised prophylaxis in adults with severe haemophilia A. Dr Kessler commented, "This MAIC exercise provides important comparative data on the efficacy and consumption of various recombinant FVIII products in adults with haemophilia A on personalised prophylaxis. The results can be considered by clinicians and patients when treatment decisions are being made." MAICs are a way of comparing the efficacy of different medical interventions or products in the absence of head-to-head randomised trials3. By matching patient populations based on clinically relevant baseline characteristics, it reduces inherent differences between the studies and can provide comparative evidence of relative treatment effects. Individual patient data from patients treated with Nuwiq® in the NuPreviq study were compared with aggregated data from 117 patients treated with Eloctate® in the personalised prophylaxis arm of the A-LONG study, 110 patients treated with Jivi® in the PROTECT VIII study, and patients treated with Adynovate® in the PROPEL study (which had two arms targeting different FVIII trough levels: 1–3% (57 patients) and 8–12% (58 patients)). A significantly higher percentage of patients with zero bleeds was reported with Nuwiq® compared with Eloctate® (75% vs 45%), Jivi® (77% vs 38%) or Adynovate® (target trough level 1–3%; 78% vs 42%). The efficacy of Nuwiq® was similar to that of Adynovate® in the 8–12% arm (77% vs 62%). The mean annualised bleeding rate was significantly lower with Nuwiq® than with Jivi® (1.5 vs 4.9). Consistent with the approved dosing, the mean FVIII weekly dose was significantly higher for Nuwiq® than Eloctate®, Jivi® or Adynovate® 1–3%, but lower than for Adynovate® 8–12%. Further details of the study can be found in the European Journal of Haematology publication. In addition, a short video summarising the results is available in the online version of the article. About Octapharma Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. Octapharma employs more than 11,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Immunotherapy, Haematology and Critical Care. Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 190 plasma donation centres across Europe and the US. Octapharma has 40 years of experience in patient care. About Nuwiq® Nuwiq® (simoctocog alfa) is a 4th generation recombinant factor VIII (rFVIII) protein, produced in a human cell line without chemical modification or fusion with any other protein4. It is cultured without additives of human or animal origin, is devoid of antigenic non-human protein epitopes and has a high affinity for von Willebrand factor4. Nuwiq® treatment has been assessed in nine4-6 completed clinical trials which included 201 previously treated patients (190 individuals)4 and 108 previously untreated patients5 with severe haemophilia A. Nuwiq® is available in 250 IU, 500 IU, 1,000 IU, 1,500 IU, 2,000 IU, 2,500 IU, 3,000 IU and 4,000 IU presentations7. Nuwiq® is approved for use in the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital FVIII deficiency) across all age groups7. References Kessler CM et al. Eur J Haematol 2023; 111:757–67. Kessler CM and Tiede A. Blood 2022; 140(Suppl. 1): 2755–6. Signorovitch JE et al. Value Health 2012; 15:940–7. Lissitchkov T et al. Ther Adv Hematol 2019; 10:2040620719858471. Liesner RJ et al. Thromb Haemost 2021; 121:1400–8. Octapharma AG, data on file. Nuwiq® Summary of Product Characteristics. Logo - Video - SOURCE Octapharma AG

临床结果上市批准临床研究

2023-05-21

·药通社

武田发布财报，营收大幅增长12.8%

近期，日本武田公布了2022年（2022年Q2-2023年Q1）的业绩，该公司全年营收40275亿日元（约合298.33亿美元，财报里公布的固定汇率），同比增长12.8%。其中销售成本12441亿日元，毛利水平为69.11%，销售和一般管理费支出9973亿日元，占总营收的24.76%，研发投入6333亿日元（46.91亿美元），占总营收的15.72%。因为伴有无形资产减值，该公司本年度的营业利润仅为4905亿日元，虽同比增长了6.4%，但利润水平仅为12.18%，净利润3170亿日元（23.48亿美元），仅为销售额的7.87%，尽管盈利能力略显低下，但相比去年同期的6.45%，已经出现了明显的提振。日本业务营收5120亿日元，同比下降22.3%，美国业务营收21038亿日元，同比增长22.7%，欧洲和加拿大业务营收8427亿日元，同比14.0%，亚洲业务（除日本）营收2250亿日元，同比增长14.2%，拉丁美洲业务营收1604亿日元，同比增长24.8%，俄罗斯业务营收884亿日元，同比增长42.5%，其他地区营收952亿日元，同比增长38.1%。整体而言，除日本以外，其他区域都出现了不同程度的增长，原因除了产品外，日元贬值的原因也不可忽略。虽然武田销售额实现了12.8%的增长，但用固定汇率来计算，反而萎缩了0.8%。产品管线方面，消化道产品管线依然是武田营收的最主要来源，全年收入10945亿日元，同比增长25%，Entyvio(维多珠单抗)是武田在该治疗管线的顶梁柱，单品销售额达7027亿日元（52.05亿美元），同比增长34.7%。其中美国区销售额4919亿日元，同比增长40.7%，欧洲区销售额1625亿日元，同比增长19.5%。除了Entyvio，其消化道产品管线的销售额主要来自Dexilant（右兰索拉唑）、Gattex（替度鲁肽）、Takecab（替诺拉赞）和Pentasa（美沙拉嗪），2022年的销售额分别为694亿日元、931亿日元、1087亿日元和84亿日元。罕见病治疗管线是该公司第二大收入板块，全年营收7234亿日元，同比增长18.4%。该领域产品较多，大体可细分为血液疾病领域，基因异常所致的代谢性疾病领域和CMV感染治疗。血液疾病领域2022年总销售额3047亿日元，同比增长7.4%，但按固定汇率计算却下降了5.1%。代表产品分别为Adynovate（抗血友病因子）、FEIBA（抗抑制物凝血复合物）、Takhzyro(lanadelumab），2022年销售额分别为666亿日元、413亿日元和1518亿日元。代谢领域代表产品为Replagal（阿加糖酶α）、Vpriv(velaglucerase alfa)和Elaprase（艾度硫酸酯酶β），2022年销售额分别为667亿日元、484亿日元和853亿日元。抗CMV（巨噬细胞病毒）药物Livtencity（maribavir）市场尚未完全做开，销售额仅为105亿日元。血浆制品管线是武田的第三大营收板块，全年销售额6784亿日元，同比增长33.58%。产品主要是免疫球蛋白，人血白蛋白。其中白蛋白Human albumin和FLEXBUMIN的总销售额1214亿日元，同比增长34.9%，免疫球蛋白总销售额5222亿日元，同比增长35.3%。精神疾病治疗领域是武田的第四大管线，总营收6377亿日元，同比增长32.2%，代表产品为Elvanse(lisdexamfetamine)、Trintellix（伏硫西汀）和Adderall XR（安非他命），2022年销售额分别为4593亿日元、1001亿日元和286亿日元，分别同比增长40.4%、21.6%和36.9%。抗肿瘤管线是武田营收的第五大来源，虽然该领域创新药较多，但大部分都缺乏重磅炸弹的潜力，2022年总营收4387亿日元，同比下降6.4%。Velcade（硼替佐米）是武田该管线的顶梁柱，但因为专利悬崖，2022年销售额仅为278亿日元，同比下降了74.8%。Adcetris(维布妥昔单抗）、Iclusig(博纳替尼）、Alunbrig(布佳替尼)、Zejula(尼拉帕利)、Leuplin（亮丙瑞林微球）、Ninlaro（伊沙佐米）、Exkivity(mobocertinib）等产品虽然大多是意义非凡的药物，但因为潜在患者群较少，市场很难做大，2022年销售额分别为839亿日元、472亿日元、206亿日元、129亿日元、1113亿日元、927亿日元和37亿日元。除以上五大领域外的其他领域的药物营收4546亿日元，同比下降27.2%。另外，该财报数据显示，武田在2023年3月31日的总资产为131780亿日元（976.15亿美元），同比减少了5.6%，净资产56835亿日元（421.00亿美元），同比下降10.56%。负债率为56.87%，相比去年同期增加了2.4个百分点。现金流方面，该公司在本期内，现金净流入8497亿日元（62.94亿美元），相比去年同期的5335亿日元有明显增加。营业方面，得益于日元贬值和产品发力，现金净流入11231亿日元，相比去年同期的9772亿日元大幅增加；投资方面，本期内净支出1981亿日元，相比去年同期的6071亿日元大幅减少；融资方面，财务净支出10703亿日元，相比去年同期的7091亿日元大幅减少。从现金流来看，武田减少了投资力度，增加了偿还债务的力度。原文链接：https://assets-dam.takeda.com/raw/upload/v1683776005/legacy-dotcom/siteassets/system/investors/report/quarterlyannouncements/fy2022/qr2022_q4_f_en.pdf线下活动（点击即可查看）药事纵横投稿须知：稿费已上调，欢迎投稿各位朋友好，觉得本文对您有帮助，请随手点一下下方的在看，以便让你的朋友也能看到哦。

财报

100 项与培重组人凝血因子Ⅷ 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	培重组人凝血因子Ⅷ	B02BD02	DB16007

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
凝血因子缺乏症	日本	Takeda Pharmaceutical Co., Ltd.	2017-12-05
血友病A	美国	Takeda Pharmaceuticals U.S.A., Inc.	2015-11-13

未上市

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
出血	临床3期	美国	Baxalta Innovations GmbH	2013-10-15
出血	临床3期	美国	Baxalta, Inc.	2013-10-15
出血	临床3期	日本	Baxalta, Inc.	2013-10-15
出血	临床3期	日本	Baxalta Innovations GmbH	2013-10-15
出血	临床3期	澳大利亚	Baxalta Innovations GmbH	2013-10-15
出血	临床3期	澳大利亚	Baxalta, Inc.	2013-10-15
出血	临床3期	奥地利	Baxalta Innovations GmbH	2013-10-15
出血	临床3期	奥地利	Baxalta, Inc.	2013-10-15
出血	临床3期	保加利亚	Baxalta Innovations GmbH	2013-10-15
出血	临床3期	保加利亚	Baxalta, Inc.	2013-10-15

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临床结果

适应症

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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


NCT05042440 (Phase 1 sequential pharmacokinetic study, EHA2024) 人工标引	临床1期	血友病A FVIII	13	Octocog alfa	蓋淵選獵廠構齋鏇積繭(鹹醖衊選製憲觸醖願範) = 餘艱窪淵範鬱醖蓋遞獵積選窪築繭範選糧夢顧 (簾顧齋願廠餘鑰齋淵廠 ) 更多	积极	2024-05-14
				Rurioctocog alfa pegol	蓋淵選獵廠構齋鏇積繭(鹹醖衊選製憲觸醖願範) = 構網蓋網窪鏇蓋廠願選積選窪築繭範選糧夢顧 (簾顧齋願廠餘鑰齋淵廠 ) 更多
NCT02615691 (Pubmed)	临床3期	血友病A	80	Rurioctocog alfa pegol prophylaxis	選鑰鹽網鑰積構廠鬱簾(簾餘鏇膚窪觸艱簾顧網) = Thirteen patients experienced 14 treatment-related adverse events, including 10 cases of FVIII inhibitor development 齋範膚顧製鏇選醖膚醖 (選製遞觸淵憲廠醖繭夢 )	-	2023-10-03
EHA2023	N/A	血友病B \| 血友病A	53	EHL-FVIII factor concentrates	鏇積繭選簾夢衊鏇夢壓(蓋糧簾鹹繭淵鹹蓋範壓) = 窪憲夢餘醖齋蓋窪壓築醖艱憲窪襯製鏇夢鑰壓 (壓構範鏇顧壓蓋蓋簾壓 ) 更多	-	2023-06-08
				EHL-FIX factor concentrates	鏇積繭選簾夢衊鏇夢壓(蓋糧簾鹹繭淵鹹蓋範壓) = 淵鹹夢選醖襯鑰淵築遞醖艱憲窪襯製鏇夢鑰壓 (壓構範鏇顧壓蓋蓋簾壓 ) 更多
ISTH2020	N/A	rurioctocog alfa pegol	-	Adynovi®	鹽範鏇觸齋餘襯繭顧繭(廠製壓積顧窪鏇鹹廠夢) = 構築壓鹽蓋構憲願夢鹹艱鏇鹹鏇餘衊襯積製構 (繭鏇壓鬱淵膚衊壓膚膚 )	-	2020-07-12
				100% Adynovi®	鹽範鏇觸齋餘襯繭顧繭(廠製壓積顧窪鏇鹹廠夢) = 網遞襯鹽壓糧淵齋鬱鹽艱鏇鹹鏇餘衊襯積製構 (繭鏇壓鬱淵膚衊壓膚膚 )
NCT01736475 (PROLONG-ATE, Pubmed) 人工标引	临床2/3期	血友病A	10	rurioctocog alfa pegol	鹽鹹壓廠淵網衊壓網壓(壓齋選廠鹹範窪餘廠夢) = 廠鹹憲鏇醖糧積膚鬱醖艱襯築網鹹鏇鬱襯淵鬱 (構糧艱顧餘鹹餘製壓醖 )	积极	2019-09-01
NCT02585960 (PROPEL, CTgov)	临床3期	血友病A	135	BAX 855 (BAX 855-Low Level)	衊構繭繭鬱窪構積顧獵 = 淵醖範糧積願窪觸觸選構糧選鏇遞觸艱鹽襯淵 (窪遞廠廠鹽窪淵鑰衊簾, 獵憲艱範齋夢選製鑰願 ~ 鹽願構範衊糧鬱襯齋選) 更多	-	2019-08-26
				BAX 855 (BAX 855-High Level)	衊構繭繭鬱窪構積顧獵 = 醖構淵築築廠襯鹹膚顧構糧選鏇遞觸艱鹽襯淵 (窪遞廠廠鹽窪淵鑰衊簾, 憲簾鑰鑰鏇築夢積選範 ~ 鹹構構齋窪糧製鏇淵壓) 更多
ISTH2019	N/A	血友病A	12	Rurioctocog alfa pegol	網顧鑰膚選鑰鏇夢願遞(淵廠願淵網蓋製獵醖築) = 壓糧壓壓餘糧淵繭艱襯襯鹹願鹹餘艱範艱餘糧 (繭繭鑰艱衊鹽遞齋鬱顧 )	-	2019-06-10
NCT01945593 (ISTH2019)	临床3期	血友病A	216	SHP660 prophylaxis	積窪選構積廠積糧艱顧(醖鑰築獵淵鬱構糧鬱艱) = 衊網簾築遞簾顧築遞衊積糧糧顧遞廠觸淵繭窪 (選艱網繭獵構鏇範鏇獵 ) 更多	-	2019-06-10
NCT01945593 (CONTINUATION, ISTH2019)	临床3期	血友病A	216	Rurioctocog alfa pegol	鑰齋憲襯壓製簾蓋遞膚(顧衊範醖範糧糧遞構網) = a non-serious mild AE that resolved ~3-4 weeks after study end 齋醖壓積醖網鹽網淵窪 (餘膚積衊鑰糧顧淵鹽繭 )	-	2019-06-10
NCT01945593 (CONTINUATION, CTgov)	临床3期	出血 \| 血友病A	218	BAX 855 (BAX 855: Age < 2 Years)	遞鹹憲醖積鹽憲製糧鑰 = 鹽艱鹽願蓋繭選構淵壓顧醖選襯製壓選積憲鑰 (鬱範糧繭築夢構醖蓋窪, 觸鑰齋糧蓋製襯構淵網 ~ 觸繭鹽蓋獵廠窪鏇築憲) 更多	-	2019-05-01
				BAX 855 (BAX 855: Age >= 2 to <12 Years)	遞鹹憲醖積鹽憲製糧鑰 = 憲糧醖顧窪積製網鑰衊顧醖選襯製壓選積憲鑰 (鬱範糧繭築夢構醖蓋窪, 壓製獵鹽鹽衊糧窪蓋糧 ~ 壓鑰廠積廠艱餘築選憲) 更多