A Multinational, Prospective, Open-label, Roll-over Study (LIBERTY) to Provide Post-trial Access to Treatment for Patients With Severe Haemophilia A Who Have Completed a Previous Trial With Efanesoctocog Alfa

This is a multinational, prospective, open-label, roll-over study in patients with severe haemophilia A, ≥6 years of age, who have completed participation in any of the parental studies with efanesoctocog alfa; XTEND-ed study (LTS16294), FREEDOM study (Sobi.BIVV001-001), or PK comparison study (Sobi.BIVV001-003). The aim of the study is to provide patients with continuous benefit from efanesoctocog alfa treatment and to further continue clinical monitoring for safety and efficacy until efanesoctocog alfa is commercially available in each patient's respective country (or until March 2027, whichever comes first).
The study starts with the Baseline Visit, which will be done in connection to the End of Study visit (or equivalent) in the respective parent study. Subsequent study visits (on site or phone call) will be done approximately every 13 weeks until End of Treatment. An End of Study safety phone call will be done 14 (+7) days after the End of Treatment Visit.

开始日期2025-01-01

申办/合作机构

Swedish Orphan Biovitrum AB

[+1]

NCT06752850

/ Recruiting临床4期

A 12-month, Interventional, Open-label, Phase 4 Study in Europe (SHINE) to Investigate the Course of Synovial Hypertrophy as Detected by Joint Ultrasound and MRI in Patients With Haemophilia A on Efanesoctocog Alfa Prophylaxis.

The rationale for conducting this open-label phase 4 study is to assess whether once-weekly prophylaxis with efanesoctocog alfa (50 IU/kg) improves the disease course of existing synovial hypertrophy and prevents the risk of joint bleeds in patients with moderate or severe haemophilia A. The use of imaging assessments will allow for objective detection and monitoring of synovial hypertrophy, and thus expand on the previous findings demonstrating positive effects of once-weekly prophylaxis with efanesoctocog alfa (50 IU/kg) on joint health.

开始日期2024-12-19

申办/合作机构

Swedish Orphan Biovitrum AB

[+1]

NCT06684314

/ RecruitingN/A

PROphylactic Efanesoctocog Alfa Therapy Evaluated for Critical Joint Health in Hemophilia A Treatment: The PROTECT-ALT Study

This is a national, multicenter, retrospective/prospective, observational study in Taiwan designed to assess effectiveness, safety, and usage of efanesoctocog alfa prophylaxis treatment in hemophilia A participants. The data related to efanesoctocog alfa effectiveness, safety and usage will be recorded prospectively during routine visits for up to 5 years following enrollment initiation and the retrospective data will be collected at least 12 months and up to 24 months prior to efanesoctocog alfa initiation. Joint imaging data will be collected in centers performing Joint U/S and/or MRI (≥6 years old). At least 12 months of retrospective data will also be collected from medical records, as available. Prospectively collected data will be recorded at routine clinical visits during a five-year follow-up period. The end of study is defined as the last participant's last visit. No intervention will be administered, and no study related visits are required.

开始日期2024-11-11

申办/合作机构

Sanofi

100 项与 Efanesoctocog alfa 相关的临床结果

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100 项与 Efanesoctocog alfa 相关的转化医学

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100 项与 Efanesoctocog alfa 相关的专利（医药）

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项与 Efanesoctocog alfa 相关的文献（医药）

2025-01-02·Expert Opinion on Drug Metabolism & Toxicology

Pharmacokinetic evaluation of efanesoctocog alfa: breakthrough factor VIII therapy for hemophilia A

Review

作者: Yada, Koji ; Nogami, Keiji

INTRODUCTION:

Blood coagulation factor (F)VIII functions as a cofactor in the tenase complex responsible for phospholipid-dependent FIXa-mediated activation of FX in plasma. Congenital defect of FVIII causes severe bleeding disorder, hemophilia (H) A. Intravenous FVIII replacement therapy is the gold standard therapy in patients with HA (PwHA) but requirement for frequent dosing of FVIII owing to pharmacokinetics burdens PwHA a lot. Efanesoctocog alfa is a new class of recombinant FVIII and has the ability to overcome conceivable unmet needs in treatment for PwHA.

AREAS COVERED:

Efanesoctocog alfa is a B domain-deleted single-chain fusion FVIII connected to the Fc-region of human immunoglobulin G1, D'D3-fragment of von Willebrand factor (VWF), and unstructured hydrophilic recombinant polypeptides (XTEN). Owing to its novel design, it can function independently of endogenous VWF and elicits 2 to 4 times longer half-life compared to other existing FVIII products. The prolonged half-life contributes to maintain high level of FVIII activity for most of the week and has led to excellent hemostatic effect by once-weekly administration in phase 3 clinical trials.

EXPERT OPINION:

Efanesoctocog alfa with outstanding pharmacological properties, well tolerated in the clinical trials, is a promising FVIII therapy for PwHA. Future studies should include long-term safety, especially in previously untreated patients.

2024-12-01·CLINICAL THERAPEUTICS

Patient Experience With Efanesoctocog Alfa for Severe Hemophilia A: Results From the XTEND-1 Phase 3 Clinical Study Exit Interviews

Article

作者: Willemze, Annemieke ; Pan-Petesch, Brigitte ; DiBenedetti, Dana ; Wilson, Amanda ; Wynn, Tung ; Neme, Daniela ; Kragh, Nana

PURPOSE:

Hemophilia A is a rare bleeding disorder that leads to recurrent hemarthrosis, which can ultimately result in reduced mobility and poor quality of life. Qualitative exit interviews provide insights into patient perspectives and support the interpretation of quantitative trial data, such as patient-reported outcome measures. In the Phase 3 XTEND-1 study (NCT04161495) of efanesoctocog alfa in participants with severe hemophilia A, exit interviews were conducted to understand pre- and post-study experiences with pain and physical functioning and to evaluate participants' treatment experiences.

METHODS:

In XTEND-1, participants (≥12 years old) received once-weekly efanesoctocog alfa prophylaxis 50 IU/kg for 52 weeks (Arm A) or on-demand efanesoctocog alfa 50 IU/kg for 26 weeks followed by 26 weeks once-weekly prophylaxis (50 IU/kg; Arm B). Optional qualitative exit interviews were conducted using a semi-structured guide in a subset of participants following study completion. Interviews included open-ended questions about participants' pre- and post-study experiences with hemophilia A and targeted questions relating to improvements in patient-reported outcomes assessed during XTEND-1, including the Haemophilia Quality of Life Questionnaire for Adults Physical Health subscale (Haem-A-QoL PH). Content validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity 3a measure was also assessed, particularly the worst pain item.

FINDINGS:

Exit interviews were conducted with 29 of 159 patients enrolled in XTEND-1 (mean [range] age 40 [16-73] years). Of 17 participants enrolled in Arm A, 13 (76.5%) reported a "wearing off" feeling with pre-study treatment, including more aches/pain, breakthrough bleeds, and limited physical activities. Joint pain was the most reported pre-study symptom (96.6%; n = 28/29), followed by a reduced ability to move without pain (89.7%, n = 26/29). Improvements following efanesoctocog alfa prophylaxis in ≥1 Haem-A-QoL PH domain were reported by 89.7% (n = 26/29) of participants, with improvements in joint pain, the ability to move without pain, and painful swellings reported by at least 21 (84%) participants. Participants reported that the PROMIS Pain Intensity 3a items were relevant, clear, and easy to answer. Most participants (96.6%) were "quite satisfied" or "very satisfied" with efanesoctocog alfa prophylaxis. All participants preferred efanesoctocog alfa over pre-study treatment.

IMPLICATIONS:

The exit interviews demonstrated that once-weekly efanesoctocog alfa prophylaxis resulted in patient-relevant and meaningful improvements in pain and physical functioning, consistent with the quantitative findings from XTEND-1. These results support the validity of the Haem-A-QoL PH and PROMIS Pain Intensity 3a assessed during XTEND-1, demonstrating the potential for change with efficacious treatment.

TRIAL REGISTRY:

ClinicalTrials.gov TRIAL REGISTRATION NUMBER: NCT04161495 REGISTRY URL: https://clinicaltrials.gov/study/NCT04161495.

2024-08-01·PEDIATRIC BLOOD & CANCER

Practical challenges associated with efanesoctocog alfa (ALTUVIIIO) prophylaxis in a 19‐month‐old male with severe hemophilia A

Letter

作者: Español, Maria G. ; Christ, Dane C. ; Tarantino, Michael D. ; Mistretta, Jessica N. ; Roberts, Jonathan C. ; Jones, Maureen D.

152

项与 Efanesoctocog alfa 相关的新闻（医药）

2025-01-10

·PRNewswire

Sobi's full year 2024 revenue higher than previous estimate

STOCKHOLM, Jan. 10, 2025 /PRNewswire/ -- Swedish Orphan Biovitrum AB (publ) (Sobi®) (STO:SOBI) announces today that revenue for the full year 2024 was higher than previous estimate. Full-year revenue was approximately SEK 26,000 M, representing approximately 19% growth at constant exchange rate (CER) (1). Adjusted EBITA margin (1,2) was in the mid-30s per cent of revenues. The main reasons for the increased revenue are higher sales than expected in Q4 across the Haemophilia portfolio and for Kineret. Altuvoct: Higher than expected rate of new patients switching to Altuvoct in markets where the product has been launched, mainly Germany and Switzerland. Elocta: Benefited from higher patient numbers across markets and in markets where Altuvoct is launched there were less switches than expected from Elocta. Favorable gross-to-net effects were also observed. Alprolix: Higher than expected number of new patients as well as increase in on-demand treatments across Europe. Kineret: Higher than expected sales driven mainly by positive gross-to-net adjustments and favorable order phasing but also supported by increased demand. The adjusted EBITA margin remained in the expected range as the stronger revenue performance was offset by negative mix effects on the gross margin as well as investments into our launch and pipeline products in the fourth quarter. At the publication of the Q3 2024 report on 24 October 2024 Sobi stated the outlook for the full year 2024 to be: Revenue was anticipated to grow by a mid-teens percentage at CER and adjusted EBITA margin was anticipated to be in the mid-30s per cent of revenue. Sobi will announce its fourth quarter and full year 2024 report on Wednesday 5 February 2025 at 8:00 am CET. About Sobi Sobi® is a specialised international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of haematology, immunology, and specialty care, Sobi has approximately 1,800 employees across Europe, North America, the Middle East, Asia, and Australia. In 2023, revenue amounted to SEK 22.1 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn. Contacts For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here. This information is information that Sobi is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 18:00 CET on 10 January 2025. Gerard Tobin Head of Investor Relations [1] Alternative Performance Measures (APMs). [2] Excluding items affecting comparability (IAC). This information was brought to you by Cision The following files are available for download: WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

财报生物类似药

2024-12-03

·PRNewswire

Sobi's strength in haematology to be showcased at ASH 2024

STOCKHOLM, Dec. 3, 2024 /PRNewswire/ -- New data from Sobi® and partners will be presented at the 66th Annual Meeting of the American Society of Hematology (ASH) in San Diego, CA (USA) from the 7th - 10th of December 2024. During the meeting several analyses will be presented on haemophilia A, haemophagocytic lymphohistiocytosis (HLH), myelofibrosis, paroxysmal nocturnal haemoglobinuria (PNH), and immune thrombocytopenia (ITP). "Haemophilia A has a lasting impact on joint health and quality of life. At ASH 2024, three oral presentations will reveal important new data about long-term outcomes with ALTUVOCT® prophylaxis," said Lydia Abad-Franch, MD, MBA, Head of Research, Development, and Medical Affairs (RDMA), and Chief Medical Officer at Sobi. "We will also present new data spanning different severe and debilitating rare diseases, including an oral presentation on the real-world effectiveness of Doptelet® in treating people with ITP, demonstrating our broader commitment to advancing innovative treatments for people with rare haematological diseases. We look forward to sharing these findings in San Diego." Key data to be presented at ASH 2024 About ALTUVOCT® ALTUVOCT® (efanesoctocog alfa) [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein] (formerly BIVV001) is the first high-sustained FVIII replacement therapy with the potential to deliver near-normal factor activity levels for a significant part of the week, improving bleed protection in a once-weekly dose for people with haemophilia A. ALTUVOCT builds on the established Fc fusion technology by innovatively adding a region of von Willebrand factor and XTEN® polypeptides to extend its time in circulation. It is the only therapy that has been shown to break through the von Willebrand factor ceiling, which imposes a half-life limitation on current factor VIII therapies. The European Commission granted Orphan Drug designation in June 2019. It is approved and marketed as ALTUVOCT by Sobi in Europe. It is approved and marketed as ALTUVIIIO™ [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl] by Sanofi in the United States, Japan, and Taiwan. About the Sanofi and Sobi collaboration Sobi and Sanofi collaborate on the development and commercialisation of Alprolix® and Elocta®/Eloctate®. The companies also collaborate on the development and commercialisation of ALTUVOCT® (efanesoctocog alfa), or ALTUVIIIO™ in the US. Sobi has final development and commercialisation rights in the Sobi territory (essentially Europe, North Africa, Russia, and most Middle Eastern markets). Sanofi has final development and commercialisation rights in North America and all other regions in the world excluding the Sobi territory. About Gamifant® Gamifant (emapalumab) is an anti-interferon gamma (IFNγ) monoclonal antibody that binds to and neutralises IFNγ. In the USA, Gamifant is indicated for the treatment of adult and paediatric (newborn and older) patients with primary haemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. Primary HLH is a rare syndrome of hyperinflammation that usually occurs within the first year of life and can rapidly become fatal unless diagnosed and treated. The FDA approval is based on data from the phase 2/3 studies (NCT01818492 and NCT02069899). Gamifant is indicated for administration through intravenous infusion over one hour twice per week until haematopoietic stem cell transplantation (HSCT). About Vonjo® Vonjo (pacritinib), a JAK-1 sparing JAK2/IRAK1/ACVR1 inhibitor, is approved for the treatment of adults with intermediate- or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L in the United States. This indication is approved under FDA accelerated approval based on spleen volume reduction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Currently, a Phase 3 study (PACIFICA) is being conducted to assess pacritinib in patients with myelofibrosis and severe thrombocytopenia as a post-marketing requirement. About Aspaveli®/ Empaveli® Aspaveli/Empaveli (pegcetacoplan) is a targeted C3 and C3b inhibitor designed to regulate excessive activation of the complement cascade, part of the body's immune system, which can lead to the onset and progression of many serious diseases. Pegcetacoplan is approved for the treatment of paroxysmal nocturnal haemoglobinuria (PNH) as Aspaveli/Empaveli in the United States, European Union, and other countries globally. Currently, a Phase 3 trial (VALIANT) is being conduted to assess the efficacy and safety of pegcetacoplan in patients with C3G and primary IC-MPGN. Aspaveli/Empaveli is also under investigation for several other rare diseases across haematology and nephrology. About the Sobi and Apellis collaboration Sobi and Apellis have global co-development rights for systemic pegcetacoplan. Sobi has exclusive ex-U.S. commercialisation rights for systemic pegcetacoplan, and Apellis has exclusive U.S. commercialisation rights for systemic pegcetacoplan and worldwide commercial rights for ophthalmological pegcetacoplan, including for geographic atrophy. About Doptelet® Doptelet (avatrombopag) is an orally administered thrombopoietin receptor agonist (TPO-RA) that mimics the biologic effects of TPO in stimulating the development and maturation of megakaryocytes, resulting in increased platelet count. It is approved in over 30 countries worldwide, including the EU and the US, for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure, and for the treatment of thrombocytopenia in adult patients with primary chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Chronic ITP is a rare autoimmune bleeding disorder characterised by low number of platelets. The incidence of primary ITP in adults is 3.3/100,000 adults per year with a prevalence of 9.5 per 100,000 adults. About Sobi® Sobi® is a specialised international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of haematology, immunology, and specialty care, Sobi has approximately 1,800 employees across Europe, North America, the Middle East, Asia, and Australia. In 2023, revenue amounted to SEK 22.1 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn. Contacts For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here. This information was brought to you by Cision The following files are available for download: WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准临床3期ASH会议孤儿药引进/卖出

2024-10-28

·GBIHealth

赛诺菲Y24Q3财报速读：制药业务收入121.67亿欧元，中国市场增长3.6%

2024年10月25日，赛诺菲发布了2024年第三季度财务业绩。2024年第三季度（报告期），公司收入134.38亿欧元（约145.47亿美元），同比增长15.7%（按固定汇率计算，下同）。制药业务收入121.67亿欧元，中国市场增长3.6% 制药业务收入121.67亿欧元，同比增长16.6%；消费者保健业务Opella收入12.71亿欧元，同比增长7.9%。 2024年前三季度，公司收入达346.47亿欧元（约375.11亿美元），同比增长11.1%。制药业务增长强劲，主要由达必妥（度普利尤单抗）和疫苗驱动。报告期内（2024年第三季度），达必妥销售额34.76亿欧元，同比增长23.8%；达必妥前三季度销售额达96.14亿欧元，同比增长25.9%。公司预测，2024年全年，达必妥销售收入可达130亿欧元。报告期内，疫苗销售额38.02亿欧元，同比增长25.5%。其中，RSV疫苗Beyfortus（尼塞韦单抗）销售额增长381.8%达6.45亿欧元。报告期内，新上市药品收入7.27亿欧元，同比增长67.1%，主要由血友病疗法ALTUVIIIO（+278.3%）、庞贝病酶替代疗法Nexviazyme/Nexviadyme（+53.6%）等驱动。报告期内，其他药品销售收入41.62亿欧元，同比增长0.4%。按市场分美国市场收入68.86亿欧元，同比增长23.6%；欧洲市场收入28.86亿欧元，同比增长6.6%；其他市场收入36.66亿欧元，同比增长10.3%。中国市场收入增长3.6% 2024年第三季度，中国市场收入7.57亿欧元（约8.19亿美元），同比增长3.6%，主要由达必妥的强劲销售驱动，但又被依诺肝素（受VBP影响）和其他药品的销售低迷抵消。中国市场也驱动贝舒地尔、胰岛素来优时（甘精胰岛素）全球销售额分别增长57.8%和18.1%。波立维尽管在中国市场已进入带量采购，但由于应用范围持续扩大，推动全球销售增长8.3%。全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作 ▶ zhangxinyue13@baidu.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

财报疫苗带量采购

100 项与 Efanesoctocog alfa 相关的药物交易

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研发状态

批准上市

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适应症	国家/地区	公司	日期
血友病A	美国	Bioverativ, Inc.	2023-02-22

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3期	美国	Biogen, Inc.	2021-02-23
出血	临床3期	美国	赛诺菲（中国）投资有限公司	2021-02-23
出血	临床3期	美国	Bioverativ Therapeutics, Inc.	2021-02-23
出血	临床3期	比利时	赛诺菲（中国）投资有限公司	2021-02-23
出血	临床3期	比利时	Bioverativ Therapeutics, Inc.	2021-02-23
出血	临床3期	比利时	Biogen, Inc.	2021-02-23
出血	临床3期	保加利亚	Bioverativ Therapeutics, Inc.	2021-02-23
出血	临床3期	保加利亚	赛诺菲（中国）投资有限公司	2021-02-23
出血	临床3期	保加利亚	Biogen, Inc.	2021-02-23
出血	临床3期	加拿大	Bioverativ Therapeutics, Inc.	2021-02-23

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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


NCT04161495 (XTEND-1, Pubmed \| Clin Ther)	临床3期	血友病A	159	Efanesoctocog alfa prophylaxis 50 IU/kg for 52 weeks	廠艱鏇觸醖顧積襯積糧(簾膚築廠壓遞餘齋蓋鑰) = 範觸廠鹹鏇蓋選鹽願襯簾艱觸築鹽蓋壓鏇顧構 (齋選遞網憲鑰選範願選 ) 更多	积极	2024-12-01
NCT04759131 (XTEND-Kids, PRNewswire) 人工标引	临床3期	血友病A	73	ALTUVOCT	願選壓顧鹽膚鑰觸鹹鹽(獵鬱淵鹽艱鑰獵壓顧鑰) = 憲選襯醖憲繭鏇壓夢繭夢蓋繭構憲觸鹹繭醖衊 (鏇衊鏇襯蓋襯餘觸築網, 0.42–0.90) 更多	积极	2024-07-18
NCT04759131 (XTEND-Kids, Pubmed)	临床3期	血友病A	74	Efanesoctocog alfa	夢繭簾憲鹹簾鏇範鹽醖(築築遞顧築繭夢鹹壓積) = Most adverse events were nonserious. No serious adverse events that were assessed by the investigator as being related to efanesoctocog alfa were reported. 積艱淵願範鹽鑰願鹽蓋 (醖顧壓製壓鏇糧淵遞窪 )	积极	2024-07-18
NCT05042440 (Phase 1 sequential pharmacokinetic study, EHA2024) 人工标引	临床1期	血友病A FVIII	13	Octocog alfa	觸餘膚淵膚遞廠鑰築淵(鏇簾遞鏇壓衊窪鹽糧窪) = 網蓋選夢蓋糧淵選鏇觸糧艱範構夢夢積鑰鹽夢 (願衊糧壓觸憲積選繭醖 ) 更多	积极	2024-05-14
	临床1期	血友病A FVIII	13	Rurioctocog alfa pegol	觸餘膚淵膚遞廠鑰築淵(鏇簾遞鏇壓衊窪鹽糧窪) = 築衊築繭鹹齋襯艱憲鑰糧艱範構夢夢積鑰鹽夢 (願衊糧壓觸憲積選繭醖 ) 更多	积极	2024-05-14
NCT04759131 (XTEND-Kids, CTgov)	临床3期	血友病A	74	efanesoctocog alfa (BIVV001) (BIVV001: Participants Aged <6 Years)	獵獵簾構構築積鑰齋顧(艱鏇糧獵積窪糧襯膚夢) = 鏇願淵網願壓憲襯觸積蓋糧願窪選網醖齋選齋 (憲襯願願鹽範範窪餘觸, 獵顧範膚襯夢窪艱鏇齋 ~ 廠網夢淵顧衊壓網製餘) 更多	-	2024-02-13
NCT04759131 (XTEND-Kids, CTgov)	临床3期	血友病A	74	efanesoctocog alfa (BIVV001) (BIVV001: Participants Aged 6 to <12 Years)	獵獵簾構構築積鑰齋顧(艱鏇糧獵積窪糧襯膚夢) = 淵遞衊顧艱顧顧選積範蓋糧願窪選網醖齋選齋 (憲襯願願鹽範範窪餘觸, 衊遞艱願膚鏇糧鬱壓鑰 ~ 齋簾廠憲憲蓋糧繭構餘) 更多	-	2024-02-13
NCT04161495 (XTEND-1, ISTH2023)	临床3期	血友病A	78	Standard-of-care FVIII prophylaxis	窪鹹糧積餘糧廠網製餘(繭憲願夢範壓築膚襯顧) = 窪鏇鏇廠糧淵觸鏇齋鑰壓製醖積繭艱艱淵膚淵 (網夢製醖觸淵醖齋積醖 )	-	2023-06-24
NCT04161495 (XTEND-1, ISTH2023)	临床3期	血友病A	78	Efanesoctocog alfa 50 IU/kg prophylaxis	窪鹹糧積餘糧廠網製餘(繭憲願夢範壓築膚襯顧) = 繭鬱鬱襯鑰襯醖範構顧壓製醖積繭艱艱淵膚淵 (網夢製醖觸淵醖齋積醖 )	-	2023-06-24
NCT04161495 (XTEND-1, ASH 12022 \| ASH 22022) 人工标引	临床3期	血友病A	159	Efanesoctocog alfa	淵齋廠網襯襯構襯觸鹽(鹹壓積鹽襯鏇襯鑰糧構) = 觸廠壓繭顧鏇構鏇衊製鑰鬱膚蓋簾構窪築網膚 (繭蓋膚醖齋窪願鹽築餘 ) 更多	积极	2022-11-15
NCT04161495 (XTEND-1, ASH 12022 \| ASH 22022) 人工标引	临床3期	疼痛 \| 血友病A	159	Efanesoctocog alfa (Arm A)	襯糧鬱膚蓋憲艱選糧艱(築繭願齋憲獵顧獵衊鑰) = was improved or maintained (change from baseline≤0) for most patients (81.5% [97/119]) at Week 52 鏇繭齋衊願醖願餘夢願 (艱鑰繭壓願築餘憲憲糧 )	积极	2022-11-15
NCT04161495 (XTEND-1, ASH 12022 \| ASH 22022) 人工标引	临床3期	疼痛 \| 血友病A	159	Efanesoctocog alfa (Arm B)		积极	2022-11-15
NCT04161495 (XTEND-1, Corporate Publications) 人工标引	临床3期	出血	150	Efanesoctocog alfa	襯糧鏇獵膚網鏇繭壓淵(鬱積衊構獵願鑰蓋艱觸) = 簾範夢鏇壓膚範簾糧齋夢願築鑰糧願淵願壓廠 (觸膚鏇簾遞壓廠繭獵壓 )	积极	2022-07-11
NCT04161495 (XTEND-1, ISTH2022)	临床3期	血友病A	217	Efanesoctocog Alfa (BIVV001)	糧窪鹽積觸醖選觸壓範(鹽衊齋選餘蓋顧餘網遞) = 窪膚觸齋糧鏇遞選憲鹹網簾餘遞齋糧醖選壓網 (餘鏇艱獵顧鑰網淵廠範 )	-	2022-07-09