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一项关于TAK-226在日本低危骨髓增生异常综合征患者中治疗输血依赖性贫血的研究

2026年9月1日 更新者：Takeda

一项2期、多中心、开放标签、单臂研究，旨在评估TAK-226治疗日本极低危、低危或中危骨髓增生异常综合征患者输血依赖性贫血的疗效和安全性

本研究的主要目的是评估TAK-226如何改善日本低风险骨髓增生异常综合征患者中输血依赖性贫血的症状。

本研究包括筛选期（最长6周）、治疗期、安全性随访期（8周）和长期随访期（从首次服用研究药物起5年或末次给药后3年，以较长者为准）。

本研究的参与者将在治疗期接受TAK-226治疗。随后，在安全性随访期和长期随访期，将对参与者进行与研究治疗相关的副作用监测。参与者的大致参与持续时间最长可达约6年。

在研究期间，参与者将根据研究计划多次访问研究诊所/医院。在治疗期，参与者大约每两到四周来诊所/医院一次。

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

42

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 日本
      • Fukuoka、日本
        • 招聘中
        • National Hospital Organization Kyushu Medical Center
      • Gifu、日本
        • 招聘中
        • Gifu Municipal Hospital
      • Nagasaki、日本
        • 尚未招聘
        • Japanese Red Cross Nagasaki Genbaku Hospital
      • Okayama、日本
        • 尚未招聘
        • Okayama City General Medical Center Okayama City Hospital
    • Bunkyo-ku
      • Tokyo、Bunkyo-ku、日本
        • 尚未招聘
        • Tokyo Metropolitan Komagome Hospital
    • Eiheiji
      • Fukui、Eiheiji、日本
        • 招聘中
        • University of Fukui Hospital
    • Fukuyama
      • Hiroshima、Fukuyama、日本
        • 招聘中
        • Japan Mutual Aid Association of Public School Teachers Chugoku Central Hospital
    • Isehara
      • Kanagawa、Isehara、日本
        • 尚未招聘
        • Tokai University Hospital
    • Kitakyushu
      • Fukuoka、Kitakyushu、日本
        • 招聘中
        • JCHO Kyushu Hospital
    • Kobe
      • Hyōgo、Kobe、日本
        • 尚未招聘
        • Kobe City Hospital Organization Kobe City Medical Center General Hospital
    • Kofu
      • Yamanashi、Kofu、日本
        • 尚未招聘
        • Yamanashi Prefectural Central Hospital
    • Matsuyama
      • Ehime、Matsuyama、日本
        • 招聘中
        • Matsuyama Red Cross Hospital
    • Mibu
      • Tochigi、Mibu、日本
        • 尚未招聘
        • Dokkyo Medical University Hospital
    • Nagoya
      • Aichi、Nagoya、日本
        • 尚未招聘
        • National Hospital Organization Nagoya Medical Center
    • Narita
      • Chiba、Narita、日本
        • 尚未招聘
        • Japanese Red Cross Narita Hospital
    • Sagamihara
      • Kanagawa、Sagamihara、日本
        • 尚未招聘
        • Kitasato University Hospital
    • Sakai
      • Osaka、Sakai、日本
        • 尚未招聘
        • Kindai University Hospital
    • Sapporo
      • Hokkaido、Sapporo、日本
        • 招聘中
        • Hokuyukai Sapporo Hokuyu Hospital
    • Sendai
      • Miyagi、Sendai、日本
        • 尚未招聘
        • National University Corporation Tohoku University Tohoku University Hospital
    • Shinagawa-ku
      • Tokyo、Shinagawa-ku、日本
        • 招聘中
        • NTT Medical Center Tokyo

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

入选标准：

  1. 参与者或其法定授权代表必须愿意并能够签署知情同意书（ICF），并遵守方案要求。
  2. 签署知情同意书时年龄≥18岁的日本成年男性或女性参与者。

  3. 根据世界卫生组织（WHO）2016年分类，诊断为伴或不伴环状铁粒幼细胞（RS）的骨髓增生异常综合征（MDS）（需在筛选期通过可评估的骨髓穿刺标本确认诊断），且符合修订版国际预后评分系统（IPSS-R）中极低危、低危或中危MDS的分类。

    注：由于输血预期会影响血红蛋白（Hgb）值，红细胞（RBC）输注后14天内采集的血样中的Hgb值以及血小板输注后7天内采集的血小板计数，不得用于评估IPSS-R以确定是否符合资格。

  4. 入组前16周内评估的输血依赖性，分为两个8周时间段，分类如下：

    a. 低输血负担（LTB），定义为每16周输注4至7单位红细胞；或 b. 高输血负担（HTB），定义为每16周输注≥8单位红细胞；且 c. 对所有参与者： i. 仅输注前Hgb<10 g/dL的输血事件计入资格评估； ii. 入组前16周内，每个8周时间段内至少有1次输血事件，且至少有2次输血事件间隔≥7天；且 iii. 入组前16周内，任何连续的56天期间不得无红细胞输注。

    注：仅针对所研究疾病的输血计入LTB或HTB参与者的分类。因并发疾病（出血、外科手术、感染等）进行的输血不予考虑。

  5. 对既往促红细胞生成素（ESA）治疗无效或不耐受（入组前已停药≥4周），或对ESA治疗不太可能有效，定义如下：

    a. 对既往ESA治疗无效：有文件记录对既往含ESA方案（无论是单药还是联合治疗，例如与粒细胞集落刺激因子[G-CSF]联合）无应答或应答不再维持；ESA方案必须满足以下条件之一： i. 重组人促红细胞生成素（EPO）≥40,000 IU/周，持续≥8次剂量或等效剂量；或 ii. 达依泊汀α≥500微克，每3周一次，持续≥4次剂量或等效剂量。 b. 对既往ESA治疗不耐受：有文件记录在引入后因不耐受或不良事件（AE）在任何时间停用既往含ESA方案（无论是单药还是联合治疗，例如与G-CSF联合）。

    c. 对ESA治疗不太可能有效：基于内源性血清EPO水平>200 U/L，对ESA应答的可能性低。

    注：由于输血预期会影响EPO水平，红细胞输注后14天内或血小板输注后7天内采集的血样不得用于评估血清EPO水平以确定是否符合资格。

  6. 筛选期采集的可评估骨髓穿刺标本中原始细胞<5%。
  7. 东部肿瘤协作组（ECOG）体能状态评分为0至2分。

  8. 有生育能力的女性（WOCBP），定义为性成熟女性，未接受过手术绝育或未自然绝经至少连续12个月，必须：

    1. 同意从签署知情同意书起至研究药物末次给药后60天内，同时使用1种高效避孕方法和1种额外有效（屏障）避孕方法；或
    2. 同意实行真正的禁欲，且这符合参与者的偏好和通常生活方式。（周期性禁欲[例如，日历法、排卵期法、症状体温法、排卵后法]、体外射精、仅使用杀精剂以及哺乳期闭经均不是可接受的避孕方法。）

  9. 男性参与者必须，即使已接受手术绝育（即输精管切除术后状态）：

    1. 同意从签署知情同意书起至研究药物末次给药后60天内，实行有效的屏障避孕；或
    2. 同意实行真正的禁欲，且这符合参与者的偏好和通常生活方式。（周期性禁欲[例如，日历法、排卵期法、症状体温法、排卵后法]、体外射精、仅使用杀精剂以及哺乳期闭经均不是可接受的避孕方法。）

排除标准：

病史

  1. 5q缺失（Del(5q)）MDS或治疗相关（继发性）MDS。
  2. 因任何其他已知原因导致的贫血（例如，地中海贫血、溶血性贫血、出血事件，或铁、维生素B12和/或叶酸缺乏）。
  3. 入组前16周内因任何非潜在MDS原因接受红细胞输注。

  4. 具有临床意义的心血管疾病，定义为：

    1. 纽约心脏病协会（NYHA）心功能分级III级或IV级；
    2. 筛选期Fridericia校正QT间期（QTcF）>500毫秒；
    3. 存在未控制的高血压，定义为筛选期平均收缩压≥160 mm Hg或舒张压≥100 mm Hg；或
    4. 筛选前6个月内存在未控制的心律失常、心肌梗死或不稳定型心绞痛。
  5. 已知射血分数<35%，由筛选期进行的局部超声心动图确认，或筛选前6个月内进行的既往超声心动图确认。
  6. 筛选前6个月内发生卒中、深静脉血栓形成或肺栓塞。
  7. 任何已知的急性髓系白血病（AML）病史。

  8. 除MDS外，既往有其他恶性肿瘤史，除非参与者已无病（包括完成既往恶性肿瘤的任何治疗，包括维持治疗）≥5年。然而，有以下病史或并发诊断的参与者，若无需系统性治疗，则允许入组：

    1. 皮肤基底细胞癌或鳞状细胞癌；
    2. 宫颈原位癌；
    3. 乳腺原位癌；和/或
    4. 前列腺癌的偶发组织学发现（采用肿瘤、淋巴结、转移[TNM]临床分期系统为T1a或T1b期）。
  9. 实体器官或骨髓移植史。
  10. 入组前28天内需要静脉使用抗生素或14天内需要口服抗生素的活动性感染。
  11. 人类免疫缺陷病毒（HIV）感染史或已知活动性或慢性感染，活动性传染性乙型肝炎病毒（HBV）感染，或活动性传染性丙型肝炎病毒（HCV）感染。乙型肝炎表面抗原（HBsAg）、乙型肝炎核心抗体（HBcAb）或乙型肝炎表面抗体（HBsAb）阳性的参与者，若其乙型肝炎病毒载量低于检测限，则可能符合入组资格。丙型肝炎病毒抗体（HCVAb）阳性的参与者，若其丙型肝炎病毒载量低于检测限，则可入组。
  12. 体重指数（BMI）≥40 kg/m²。
  13. 入组前28天内接受过大手术。

  14. 对研究药物（IMP）辅料（参见当前elritercept [TAK 226]研究者手册[IB]中的辅料列表）或重组蛋白有过敏/过敏反应史。

    治疗史

  15. 既往使用过TAK 226、luspatercept、imetelstat或sotatercept。
  16. 既往使用过用于治疗MDS的去甲基化药物（HMA）、异柠檬酸脱氢酶抑制剂、来那度胺或免疫抑制治疗。
  17. 入组前8周内开始铁螯合治疗。允许接受稳定剂量铁螯合治疗≥8周的参与者入组。
  18. 入组前4周内开始维生素B12或叶酸治疗。允许接受稳定替代剂量≥4周且无并发维生素B12或叶酸缺乏的参与者入组。
  19. 入组前8周内使用雄激素。允许因性腺功能减退接受稳定剂量雄激素治疗≥8周的参与者入组。
  20. 入组前4周内使用高剂量皮质类固醇。允许接受稳定慢性剂量泼尼松/泼尼松龙≤10 mg/天或等效皮质类固醇剂量≥4周的参与者入组。
  21. 筛选前28天内接受过任何研究药物治疗，或如果产品半衰期已知，则在筛选前5倍半衰期内（以较长者为准）接受过研究药物治疗。
  22. 正在参与另一项干预性临床研究。实验室排除标准（筛选期）
  23. 血清EPO水平>500 U/L。注：由于输血预期会影响EPO水平，红细胞输注后14天内采集的血样实验室结果不得用于评估血清EPO水平以确定是否符合资格。
  24. 血小板计数≥450×10³/微升或≤25×10³/微升。注：由于输血预期会影响血小板计数，血小板输注后7天内采集的血样实验室结果不得用于评估血小板计数以确定是否符合资格。
  25. 绝对中性粒细胞计数≤500/微升。
  26. 血清天冬氨酸氨基转移酶（AST）或丙氨酸氨基转移酶（ALT）≥3×正常值上限（ULN）。
  27. 总胆红素≥2×ULN，除非归因于吉尔伯特综合征。
  28. 铁蛋白≤50微克/升。
  29. 叶酸≤2.0纳克/毫升。
  30. 维生素B12≤200皮克/毫升。

  31. 日本肾脏病学会确定的估算肾小球滤过率（eGFR）<30毫升/分钟/1.73平方米。采用日本人校正公式计算：eGFR=194×（血清肌酐值）^-1.094×（年龄）^-0.287×（性别校正因子），性别校正因子：女性为0.739。

    其他

  32. 妊娠或哺乳期女性。注：根据医生访谈可能处于极早期妊娠且妊娠试验阴性的参与者被排除在研究之外。正在哺乳的参与者如果从研究药物首次给药前至末次给药后60天停止哺乳，则符合资格。
  33. 研究者认为，任何上述未特别提及的、可能妨碍参与者参与研究或可能混淆研究数据解释的其他情况。
  34. 直接参与研究实施的临床研究中心工作人员、受研究者监督的其他研究中心工作人员、直接参与研究实施的申办方或合同研究组织（CRO）员工，或直系亲属（定义为配偶、父母、子女或兄弟姐妹，无论是生物学上的还是法律上收养的）。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：TAK-226
Participants will receive the study drug, TAK-226, administered subcutaneously every four weeks (Q4W) for approximately one year during Treatment Period.
药品：TAK-226
TAK-226皮下注射
其他名称：
  • 依立西普
  • KER-050

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Transfusion dependent (TD) cohort: Percentage of Participants Achieving Transfusion Independence (TI) for Greater Than or Equal to (>=) 8 Weeks from Baseline through Week 24
大体时间：Baseline, Up to Week 24
Transfusion independence is defined as the absence of any red blood cells (RBC) transfusions in a period of at least 8 weeks after the first dose of the study treatment through week 24.
Baseline, Up to Week 24
Non-transfusion dependent (NTD) cohort: Percentage of Participants Achieving Mean Hgb Increase of >=1.5 grams per deciliter (g/dL) for >=8 Weeks from Baseline through Week 24 And No RBC Transfusion during the Same >=8 Weeks Period
大体时间：Baseline, Up to Week 24
Baseline, Up to Week 24

次要结果测量

结果测量
措施说明
大体时间
TD cohort: Percentage of Participants Achieving TI for >=24 Weeks from Baseline through Week 48
大体时间：Baseline, Up to Week 48
Transfusion independence is defined as the absence of any red blood cells (RBC) transfusions in a period of at least 24 weeks after the first dose of the study treatment through week 48.
Baseline, Up to Week 48
TD cohort: Percentage of Participants with High Transfusion Burden (HTB) Achieving TI for >=8 Weeks from Baseline through Week 24
大体时间：Baseline, Up to Week 24
Transfusion independence is defined as the absence of any RBC transfusions in a period of at least 8 weeks after the first dose of the study treatment through week 24.
Baseline, Up to Week 24
TD cohort: Percentage of Participants Achieving Mean Hemoglobin (Hgb) Increase of >=1.5 g/dL for >=8 Weeks from Baseline through Week 24
大体时间：Baseline, Up to Week 24
Baseline, Up to Week 24
TD cohort: Number of Participants with Treatment-Emergent Adverse Event (TEAEs) and Serious Adverse Event (SAEs)
大体时间：Up to approximately 6 years
An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the trial intervention. A TEAE is defined as an AE that commences on or after the first dose of the study treatment and within 60 days after the last dose of the study treatment, or analysis cutoff date, whichever is earlier. An SAE is any untoward medical occurrence that, at any dose: results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event.
Up to approximately 6 years
TD cohort: Serum Concentration of TAK-226
大体时间：Baseline, and multiple time points up to the end of Treatment Period (approximately 12 months)
TAK-226 time-concentration data will be assessed.
Baseline, and multiple time points up to the end of Treatment Period (approximately 12 months)
TD cohort: Number of Participants with Treatment-Emergent Anti-Drug Antibody (ADA)
大体时间：Up to the end of Safety Follow-Up Period (approximately 14 months)
Up to the end of Safety Follow-Up Period (approximately 14 months)
TD cohort: ADA Titer
大体时间：Baseline, and multiple time points up to approximately 24 months
Baseline, and multiple time points up to approximately 24 months
NTD cohort: Percentage of Participants Achieving Mean Hgb Increase of >=1.5 g/dL for >=12 Weeks from Baseline through Week 24 And No RBC Transfusion during the Same >=12 Weeks Period
大体时间：Baseline, Up to Week 24
Baseline, Up to Week 24
NTD cohort: Percentage of Participants Achieving Consecutive Hgb Increase of >=1.5 g/dL for >=8 Weeks from Baseline through Week 24 And No RBC Transfusion during the Same >=8 Weeks Period
大体时间：Baseline, Up to Week 24
Baseline, Up to Week 24
NTD cohort: Percentage of Participants Achieving Mean Hgb Increase of >=1.5 g/dL for >=16 Weeks from Baseline through Week 24 And through Week 48, And No RBC Transfusion during the Same >=16 Weeks Period
大体时间：Baseline, Up to Week 24 and Week 48
Baseline, Up to Week 24 and Week 48
NTD cohort: Number of Participants with TEAEs and SAEs
大体时间：Up to approximately 6 years
Up to approximately 6 years
TD and NTD cohorts: Change from baseline in Hematocrit
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Hemoglobin
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Red Cell Distribution Width
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Red Blood Cell
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Reticulocyte
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Reticulocyte Cell Hemoglobin
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Platelet
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in White Blood Cell
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Neutrophils
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Eosinophils
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Basophils
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Lymphocytes
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Monocytes
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Mean Corpuscular Volume
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Mean Corpuscular Hemoglobin
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Mean Cell Hemoglobin Concentration
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Albumin
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Total Protein
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Blood Glucose
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Sodium
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Potassium
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Chloride
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Blood Urea Nitrogen
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Creatinine
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Aspartate Aminotransferase
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Alanine Aminotransferase
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Alkaline Phosphatase
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Gamma Glutamyl Transferase
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Total Bilirubin
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Lactate Dehydrogenase
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Calcium
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Magnesium
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Phosphorus
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Uric Acid
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Erythropoietin
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Thrombopoietin
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in N-Terminal Prohormone of Brain Natriuretic Protein
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Serum Iron
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Ferritin
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Transferrin
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Transferrin Saturation
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Total Iron Binding Capacity
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Soluble Transferrin Receptor
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Hepcidin
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Blood Pressure
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Heart Rate
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Respiratory Rate
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in Body Temperature
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in PR Interval
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in QRS Duration
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in QT Interval
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months
TD and NTD cohorts: Change from baseline in QTcF Interval
大体时间：From the time of signing the informed consent form through safety follow-up, approximately 16 months
From the time of signing the informed consent form through safety follow-up, approximately 16 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Takeda

调查人员

  • 研究主任：Study Director、Takeda

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年4月22日

初级完成 (估计的)

2028年6月26日

研究完成 (估计的)

2033年1月10日

研究注册日期

首次提交

2025年12月22日

首先提交符合 QC 标准的

2025年12月22日

首次发布 (实际的)

2026年1月6日

研究记录更新

最后更新发布 (实际的)

2026年9月2日

上次提交的符合 QC 标准的更新

2026年9月1日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • TAK-226-2001
  • jRCT2031250603 (注册表标识符：jRCT)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

武田（Takeda）提供符合条件研究的去标识化个体参与者数据（IPD）访问权限，以协助合格研究人员解决合理的科学目标（武田的数据共享承诺详见 https://clinicaltrials.takeda.com/takedas-commitment?commitment=5）。 这些IPD将在数据共享请求获得批准后，在安全的研究环境中并根据数据共享协议的条款提供。

IPD 共享访问标准

符合条件的研究中的IPD将根据https://vivli.org/ourmember/takeda/上描述的标准和流程与合格的研究人员共享。 对于已批准的请求，研究人员将获得访问匿名化数据的权限（以尊重患者隐私，符合适用法律法规），并根据数据共享协议的条款提供解决研究目标所需的信息。

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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