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]

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

NCT06579144 / Not yet recruiting临床1期

An Open-label, Multicentre Study to Compare the Pharmacokinetics of Efanesoctocog Alfa Versus rFVIII Products, Damactocog Alfa Pegol or Turoctocog Alfa Pegol, After a Single Intravenous Dose of 50 IU/kg in a Fixed Sequence in Previously Treated Adults With Severe Haemophilia A.

Sobi.BIVV001-003 is an open-label, 2-period, fixed sequence study for intra-participant comparison of the PK profiles of efanesoctocog alfa and the extended half-life rFVIII products damactocog alfa pegol or turoctocog alfa pegol after a single i.v. injection in previously treated males, 18-65 years of age, with severe haemophilia A.
Participants who are receiving treatment with damoctocog alfa pegol (n
12) or turoctocog alfa pegol (n
12) will be enrolled in the study. The study will start with a screening period (up to 28 days), including a wash-out period prior to start of the actual study period.
During the the first visit, a single dose of damactocog alfa pegol or turoctocog alfa pegol (corresponding to the participant's pre-study treatment) will be administered. A PK sampling period will follow over 7 visits. Following completion of the PK sampling of the original treatment regimen, the patients will be given a single dose of efanesoctocog alfa at visit 8, after which a new PK sampling period will follow (visit 8-15).
The primary objective for the study is to compare the half-life of efanesoctocog alfa with that of the two comparator drugs after a single iv. injections.
Secondary objectives include comparison of area under the curve for efanesoctocog alfa vs. the two comparator drugs, characterization of PK parameters for all three drugs as well as well as to evaluate safety and tolerability of a single iv. injection of efanesoctocog alfa.

开始日期2024-11-01

申办/合作机构

Swedish Orphan Biovitrum AB

[+1]

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）

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.

2024-07-23·EXPERT OPINION ON PHARMACOTHERAPY

Factor VIII stimulants and other novel therapies for the treatment of von Willebrand disease: what’s new on the horizon?

Review

作者: Sidonio, Robert F. ; Regling, Katherine

INTRODUCTION:

Von Willebrand disease (VWD) is the most common inherited bleeding disorder, affecting about 0.6% to 1.3% of the population, and is characterized primarily by mucocutaneous bleeding secondary to defective platelet adhesion and aggregation. Current therapeutic options for those with severe disease are limited and require frequent intravenous infusions.

AREAS COVERED:

This review discusses the current and recently completed clinical trials involving pathways to FVIII augmentation for the treatment of VWD. Clinical trials registered on clinicaltrials.gov and published data via PubMed searches through June 2024 were included.

EXPERT OPINION:

Available treatment options to those with VWD are limited in part due to limited clinical trials, the complexity of VWD types, and the pharmacokinetics of current treatment options. The development of therapeutic options that reduce treatment burden is necessary to improve quality of life and reduce bleeding complications and in recent years there has been an increased interest from industry to apply novel therapeutics for VWD. The FVIII mimetic, emicizumab, has demonstrated early success in patients with severe VWD and is a promising treatment option for those who require prophylaxis. Furthermore, products like efanesoctocog alfa (Altuviiio®) and BT200 have achieved enhanced VWF/FVIII half-life extension could expand the current treatment landscape while concurrently minimizing treatment burden.

151

项与 Efanesoctocog alfa 相关的新闻（医药）

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

2024-10-28

·echemi

Merck's RSV Antibody Faces Major Challenges vs. Sanofi's Beyfortus Exhibiting 83% Efficacy in Reducing Hospitalization

While Merck & Co. 's infant respiratory syncytial virus (RSV) antibody clesrovimab is nearing approval, sanofi also won approval last year for its RSV prevention drug beyforts in partnership with astrazeneca. This news undoubtedly brings new hope to the global healthcare industry, especially in the field of RSV vaccines. "We would very much welcome having more participants on board because it increases the scale of the competition," Thomas Triomphe, Sanofi's executive vice president for vaccines, said of the upcoming RSV competition during an analyst call on Friday. He stressed that more players mean more innovation and better healthcare solutions, which is good for the industry as a whole and for patients. Triomphe noted that Merck still has more data on clesrovimab after announcing phase 2b/3 clinical results last week. In the meantime, Sanofi remains "very confident" in the Beyfortus numbers it has released so far, he said. He mentioned that the protection data provided by Beyfortus in six months is very encouraging, as the effect has not diminished. "After six months, we were still seeing 83 percent hospitalization efficacy," he said, adding that he believed "the duration of protection from Beyfortus was significantly more favorable compared to clesrovimab." This data suggests that Beyfortus has a significant advantage in preventing RSV infection. In Merck's infant RSV study, clesrovimab successfully reduced RSV-related hospitalizations and RSV-related lower respiratory tract infection hospitalizations by 84 percent and 91 percent, respectively, over five months compared to placebo. This result is impressive and shows the great potential of clesrovimab in preventing RSV infection. At the trial's primary endpoint, clesrovimab reduced the incidence of RSV-related medical lower respiratory tract infections by 60 percent compared to placebo. This data provides further evidence of the effectiveness of clesrovimab in preventing RSV infection. Sanofi Chief Financial Officer franois-xavier Roger noted in a conference call on Friday that the inherent uncertainty of cross-trial comparisons suggested that existing Beyfortus data showed a reduction of about 75 percent in the incidence of lower respiratory tract infections with clesrovimab compared to 60 percent with Clesrovimab. This data further reinforces Beyfortus' advantage in preventing RSV infection. And, whether or not Merck brings clesrovimab into the 2025-2026 RSV season as planned, "2025 will be a year of growth for Beyfortus," the CFO stressed. He is confident that Beyfortus' sales will grow significantly as it gradually gains market share. Since it was approved last July, Beyfortus has gradually built up its sales profile. In the third quarter of 2024, sales of this preventive antibody reached 645 million euros ($699), an increase of 382% compared to the same period in 2023. Overall, sales of the drug have reached 845 million euros since the beginning of the year, which is close to the best-selling threshold. Sanofi said at the time that Beyfortus quickly fell into a supply crunch shortly after going public last year due to "higher than expected demand." To counter this, Sanofi and its partner Astrazeneca have moved quickly to ensure there is no repeat of the supply crunch in 2024. Recently they added a new filling line and shipped antibody doses ahead of the 2024 RSV season. "There are 20 markets and we don't see any capacity constraints," Triumph said on Sanofi's conference call. "We will increase supply next year and the year after to make sure there are no supply constraints." This initiative demonstrates Sanofi's confidence in the future of Beyfortus and its commitment to meeting the needs of the global market. The comments by Sanofi executives came as the French pharmaceutical company reported a 15.7 per cent rise in third-quarter sales. This growth was mainly driven by the excellent performance of its immunology product Dupixent, which brought in sales of nearly 3.5 billion euros (about $3.8 billion), an increase of about 24 percent over the third quarter of 2023. Sanofi confirmed DuPont's full-year sales target of about 13 billion euros. Elsewhere, newly launched drugs rose 67.1 percent to 727 million euros ($787), led by hemophilia drug Altuviiio, Pompeii disease treatment Nexviazyme and Rezurock for graft-versus-host disease. The strong performance of these new drugs further strengthens Sanofi's position in the field of innovative medicines. Meanwhile, Sanofi's consumer health division, Opella, saw revenue rise 7.9 percent. This growth shows that Sanofi is also making significant progress in consumer health. Earlier this week, Sanofi confirmed it had entered exclusive talks with U.S. private equity firm Clayton, Dubilier & Rice to sell a controlling 50 percent stake in its consumer healthcare business, which is valued at around 16 billion euros. This move will further strengthen Sanofi's financial strength and provide additional financial support for its future expansion.

上市批准临床结果疫苗

100 项与 Efanesoctocog alfa 相关的药物交易

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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

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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	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	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	壓積顧壓遞醖襯艱遞餘(顧膚鑰願鹹窪網範觸鏇) = 築廠艱築構窪構顧襯鹽觸鹽衊顧顧網顧觸淵網 (鑰築憲鹹夢艱製鑰願繭 ) 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	願鑰遞齋廠構蓋繭鑰醖(淵鹽襯夢選築醖壓繭鏇) = 淵鹹淵衊製觸鏇鏇廠壓憲餘膚願觸顧網鏇顧鏇 (網築鏇簾壓廠積網獵範, 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	醖製醖淵觸簾膚醖選膚(膚壓獵衊衊鏇艱餘齋衊) = Most adverse events were nonserious. No serious adverse events that were assessed by the investigator as being related to efanesoctocog alfa were reported. 夢艱蓋壓糧選襯餘鹽鏇 (範憲夢衊餘餘憲膚衊糧 )	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	襯糧窪齋淵獵遞糧範網(築願築鹹襯願憲鑰願積) = 膚餘夢餘夢窪鬱夢獵夢襯鑰鑰構糧遞廠鏇窪鹹 (鬱襯構範淵壓鹹襯鏇窪 ) 更多	积极	2024-05-14
	临床1期	血友病A FVIII	13	Rurioctocog alfa pegol	襯糧窪齋淵獵遞糧範網(築願築鹹襯願憲鑰願積) = 壓襯簾顧構遞齋獵鬱窪襯鑰鑰構糧遞廠鏇窪鹹 (鬱襯構範淵壓鹹襯鏇窪 ) 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)	襯鑰壓衊鏇鏇選糧願夢(願憲衊艱遞積醖觸糧醖) = 艱艱糧夢廠築積淵鹹鬱糧鹽鏇觸齋觸網製積築 (淵壓積構襯膚遞範鏇廠, 顧積糧顧鬱糧憲廠積鏇 ~ 積選糧窪簾齋構網鏇襯) 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)	襯鑰壓衊鏇鏇選糧願夢(願憲衊艱遞積醖觸糧醖) = 糧願範淵糧蓋衊糧鏇鑰糧鹽鏇觸齋觸網製積築 (淵壓積構襯膚遞範鏇廠, 顧鬱範鏇築顧廠醖鹽鑰 ~ 鑰選衊鹹築鬱鑰艱鹹鏇) 更多	-	2024-02-13
XTEND-1 (ISTH2023)	临床3期	血友病A	78	Standard-of-care FVIII prophylaxis	積鹹簾顧獵蓋構願憲積(簾餘鏇簾觸窪網選構壓) = 窪鬱膚醖範鑰夢糧製餘窪範蓋淵廠膚築觸範獵 (願築觸鏇願窪憲鹽鑰構 )	-	2023-06-24
XTEND-1 (ISTH2023)	临床3期	血友病A	78	Efanesoctocog alfa 50 IU/kg prophylaxis	積鹹簾顧獵蓋構願憲積(簾餘鏇簾觸窪網選構壓) = 膚遞範顧糧衊夢製廠襯窪範蓋淵廠膚築觸範獵 (願築觸鏇願窪憲鹽鑰構 )	-	2023-06-24
NCT04161495 (XTEND-1, ASH2022) 人工标引	临床3期	疼痛 \| 血友病A	159	Efanesoctocog alfa (Arm A)	鬱衊衊構鬱繭遞齋膚製(餘鏇淵膚顧顧夢醖積遞) = was improved or maintained (change from baseline≤0) for most patients (81.5% [97/119]) at Week 52 簾齋選廠壓顧廠製壓簾 (網獵網齋繭積願艱積願 )	积极	2022-11-15
NCT04161495 (XTEND-1, ASH2022) 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, ASH2022) 人工标引	临床3期	血友病A	159	Efanesoctocog alfa	築顧窪餘顧築淵鹽衊繭(襯觸構範願壓淵艱積顧) = 憲餘壓鹹選衊醖顧衊簾範鹽願夢選鹽製鬱衊壓 (鏇鬱獵鬱顧襯網積窪艱 ) 更多	积极	2022-11-15
NCT04161495 (XTEND-1, Corporate Publications) 人工标引	临床3期	出血	150	Efanesoctocog alfa	艱鬱遞選鏇壓壓醖衊壓(獵簾蓋壓簾蓋網積窪淵) = 範製顧積衊鑰夢構顧壓選憲蓋製繭構餘顧衊蓋 (遞壓鹹範積鏇積膚衊願 )	积极	2022-07-11
XTEND-1 (ISTH2022)	临床3期	血友病A	217	Efanesoctocog Alfa (BIVV001)	鑰築鹽範壓構鬱選顧廠(顧襯窪築醖衊獵構襯餘) = 壓顧淵觸廠膚鬱選願獵衊製糧膚餘獵鏇積窪鹹 (構顧簾製觸鬱憲選選蓋 )	-	2022-07-09