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一项关于转甲状腺素蛋白淀粉样变性心肌病患者从Tafamidis转换为Acoramidis时血液中转甲状腺素蛋白水平变化的研究 (ACO-SWITCH)

2026年10月14日 更新者：Bayer

一项前瞻性、单臂、4期研究，旨在评估曾接受他法米迪斯治疗的变异型或野生型转甲状腺素蛋白淀粉样变性心肌病（ATTR-CM）成年患者使用阿科拉米迪斯后血清转甲状腺素蛋白（TTR）水平的变化过程

Transthyretin (TTR) is a protein made by the liver that helps transport thyroid hormone and vitamin A in the blood. In some people, this protein breaks down and forms harmful clumps called amyloid. TTR amyloid gets deposited in the heart wall and stops it from pumping blood properly, which may lead to heart failure. The breakage in TTR protein can be age-related (wild-type ATTR-CM), or genetic (variant ATTR-CM).

The study drug, acoramidis, works by attaching itself to the TTR protein, making TTR more stable and less likely to break down and form amyloid (clumps). This helps to slow down the progression of the disease, improve heart function, and increase the TTR levels in the blood. Acoramidis is an approved treatment for wild-type or variant ATTR-CM in Europe and the United States.

Tafamidis is another drug that stabilizes TTR and prevents it from breaking down.

In this study, acoramidis will be studied in participants with ATTR--CM who were previously treated with tafamidis. The main purpose of this study is to assess the change in blood TTR levels after participants are switched from tafamidis to acoramidis. This will be studied to understand if acoramidis causes an increase in blood TTR levels beyond the levels achieved with tafamidis.

For this, the researchers will measure the change in the levels of TTR protein in participants' blood after 6 months of the treatment with acoramidis, or earlier if a participant stops the treatment before reaching that six-month mark.

All participants will continue taking tafamidis during the screening period. In the treatment period of the study, participants will take acoramidis as two tablets twice daily by mouth, for up to 6 months.

At the start of this study, the study doctors will review each participant's medical history and check their overall health. The study doctors will perform electrocardiograms (ECG), and measure blood pressure and heart rate. Researchers will also take blood and urine samples from the participants to measure levels of TTr, NT-proBNP, hs-TnT, hs-CRP, RBP4, eGFR, creatinine, cystatin-C, UACR, and TSH at the start of the study, and at various time points thereafter (during the study) to assess heart, kidney and thyroid function.

There will be a total of 9 study check-ins. Participants will visit the study site twice: at screening and at the end of treatment period. A study nurse will visit the participant's home 6 times, at the start of treatment, Weeks 1, 2, 3 and 4, then again at 3 months. The final check-in will be done by phone.

The study doctors will monitor the health of the participants regularly for any medical problems during follow-up visits. Participants will know the treatment they will receive during the study. Each participant could be in the study for about 8 months.

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)

50

阶段

  • 第四阶段

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

  • 奥地利
    • Lower Austria
      • Sankt Pölten、Lower Austria、奥地利、1210
        • 撤销
        • Universitätsklinikum St. Pölten - Lilienfeld - Klinische Abteilung für Innere Medizin 3
    • State of Vienna
      • Vienna、State of Vienna、奥地利、3500
        • 尚未招聘
        • Klinik Ottakring - 3. Medizinische Abteilung mit Kardiologie, internistischer Intensivmedizin und Ambulanz
      • Vienna、State of Vienna、奥地利、1090
        • 招聘中
        • Medizinische Universität Wien- Universitätsklinik für Innere Medizin II, Klinische Abteilung für Kardiologie
      • Vienna、State of Vienna、奥地利、1100
        • 招聘中
        • Klinik Favoriten - 5.Medizinische Abteilung-Kardiologie
    • Styria
      • Vienna、Styria、奥地利、1030
        • 招聘中
        • Medizinische Universität Graz- Klinische Abteilung für Kardiologie
    • Upper Austria
      • Braunau am Inn、Upper Austria、奥地利、5280
        • 招聘中
        • Krankenhaus St. Josef Braunau | Innere Medizin I
    • Vorarlberg
      • Feldkirch、Vorarlberg、奥地利、6800
        • 撤销
        • VIVIT - Landeskrankenhaus Feldkirch - Innere Medizin I, Kardiologie, Angiologie, Endokrinologie, Diabetologie, Intensivmedizin
  • 德国
      • Berlin、德国、10365
        • 撤销
        • Sana Klinikum Lichtenberg - Klinik für Innere Medizin II, Schwerpunkt Kardiologie
      • Hamburg、德国、20246
        • 撤销
        • Universitätsklinikum Hamburg Eppendorf (UKE)-Universitären Herz- und Gefäßzentrum Hamburg, Klinik für Kardiologie
    • Baden-Wurttemberg
      • Ulm、Baden-Wurttemberg、德国、89081
        • 撤销
        • Universitaetsklinikum Ulm | Klinik fuer Innere Medizin II
    • Hesse
      • Darmstadt、Hesse、德国、64287
        • 尚未招聘
        • KVZ Kardiovaskulaeres Zentrum Darmstadt GmbH
    • Mecklenburg-Vorpommern
      • Greifswald、Mecklenburg-Vorpommern、德国、17475
        • 撤销
        • Universitaetsmedizin Greifswald KöR- Klinik und Poliklinik für Innere Medizin B
    • North Rhine-Westphalia
      • Bonn、North Rhine-Westphalia、德国、53127
        • 撤销
        • Universitätsklinikum Bonn - Herzzentrum des Universitätsklinikums Bonn
  • 意大利
      • Naples、意大利、80131
        • 尚未招聘
        • Azienda Ospedaliera Dei Colli_Monaldi - Malattie Rare e Genetiche Cardiovascolari
    • Apulia
      • Lecce、Apulia、意大利、73100
        • 尚未招聘
        • Ospedale Vito Fazzi Lecce_Cardiologia e UTIC
    • Emilia-Romagna
      • Bologna、Emilia-Romagna、意大利、40138
        • 尚未招聘
        • Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola_Cardiologia
    • Lombardy
      • Bergamo、Lombardy、意大利、24127
        • 招聘中
        • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Cardiologia 1
      • Milan、Lombardy、意大利、20138
        • 招聘中
        • Centro Cardiologico Monzino S.p.A. - Cardiologia Peri-Operatoria e Imaging Cardiovascolare
      • Pavia、Lombardy、意大利、27100
        • 尚未招聘
        • Fondazione IRCCS Policlinico San Matteo-SC Medicina Generale 2 - Centro Amiloidosi Sistemiche e Malattie ad Alta Complessità
    • Tuscany
      • Florence、Tuscany、意大利、50134
        • 招聘中
        • Careggi University Hospital_cardio intensive care unit
      • Pisa、Tuscany、意大利、56124
        • 招聘中
        • Fondazione Toscana Gabriele Monasterio_Pisa - Cardiologia e Medicina Cardiovascolare
      • Siena、Tuscany、意大利、53100
        • 招聘中
        • Azienda Ospedaliera Universitaria Senese - cardiologia
    • Veneto
      • Padova、Veneto、意大利、35128
        • 招聘中
        • Azienda Ospedale-Università di Padova-UOC Cardiologia
  • 挪威
      • Oslo、挪威、0424
        • 尚未招聘
        • Oslo Universitetssykehus HF, Rikshospitalet
  • 比利时
    • Brussels Capital
      • Brussels、Brussels Capital、比利时、1070
        • 尚未招聘
        • Hôpital Erasme/Erasmus Ziekenhuis
    • West Flanders
      • Bruges、West Flanders、比利时、8000
        • 尚未招聘
        • AZ St-Jan Brugge-Oostende A.V.

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

18年 至 90年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Participants must be 18 to 90 years of age inclusive, at the time of signing the informed consent.
  • Diagnosis of ATTR-CM; disease defining examination, i.e., Single Photon Emission Computed Tomography (SPECT) or SPECT/Computed Tomography (CT) or biopsy, within 24 months prior to Visit 1 (V1).
  • Participants must currently be treated with tafamidis and have used tafamidis for at least the previous 3 months prior to V1 and have adhered to tafamidis therapy.
  • New York Heart Association (NYHA) class ≤ II at V1.
  • Estimate glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m^2 at V1.
  • N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) > 300 and ≤ 7000 pg/mL at V1.

Exclusion Criteria:

  • Prior liver or heart transplantation or planned within the next 12 months.
  • Current or planned use of ventricular assist device.
  • Active cancer or other disease that decreases the life expectancy to less than one year.
  • Heart failure due to ischemic heart disease.
  • Myocardial infarction, cardiovascular (CV) surgery, or unstable angina within the last 90 days prior to V1.
  • Confirmed diagnosis of light-chain amyloidosis.
  • Dialysis or severe renal impairment as reflected by Urinary Albumin Creatinine Ratio (UACR) > 300 mg/g at V1.
  • Major surgery within 90 days prior to V1.
  • Recent initiation of Sodium-Glucose-Cotransporter-2 inhibitors (SGLT2i) within 3 months before V1.
  • Initiation of treatment with a diuretic or increase in diuretic dose within 3 months before V1.
  • Treatment with calcium channel blockers (e.g., verapamil, diltiazem) or digitalis.
  • Recent CV hospitalization within 3 months before V1.
  • Known hypersensitivity to acoramidis or to any of the excipients.
  • A condition that, as judged by the investigator, would preclude compliance with the study protocol, such as a history of substance abuse, alcoholism, or a psychiatric condition.
  • Known or suspected liver disorder and bile secretion/flow (cholestasis, also history of it).
  • Abnormal liver function tests at V1, defined as ALT (GPT) or AST (GOT) ≥ 3 x ULN or total bilirubin ≥ 3 x ULN at V1.

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：Acoramidis

Participants will receive acoramidis 712 mg orally BID
药品：Acoramidis

356 mg film-coated tablets.

The recommended dose of acoramidis is 712 mg (two tablets, 356 mg) orally, twice daily, corresponding to a total daily dose of 1424 mg.

其他名称：
  • BEYONTTRA
  • BAY3684938

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
Change in serum TTR level from baseline to month 6 or premature discontinuation of treatment
大体时间：From baseline to month 6 or premature discontinuation of treatment

TTR = Transthyretin
From baseline to month 6 or premature discontinuation of treatment

次要结果测量

结果测量
措施说明
大体时间
出现TEAE和严重TEAE的参与者人数
大体时间：从首次服用研究药物开始，至末次服用研究药物后30天或研究结束（以先发生者为准）
从首次服用研究药物开始，至末次服用研究药物后30天或研究结束（以先发生者为准）
从基线至第6个月肌酐的变化
大体时间：从基线到第6个月
从基线到第6个月
从基线至第6个月胱抑素C的变化
大体时间：从基线至第6个月
从基线至第6个月
Change in serum TTR level from baseline to week 1, 2, 3, 4 and at month 3.
大体时间：At baseline, week 1, 2, 3, 4 and at month 3

TTR = Transthyretin
At baseline, week 1, 2, 3, 4 and at month 3
Change from baseline to month 6 of NT-proBNP
大体时间：From baseline to month 6

NT-proBNP = N-terminal pro-B-type Natriuretic Peptide
From baseline to month 6
Change from baseline to month 6 of hs-TnT
大体时间：From baseline to month 6

hs-TNT = high-sensitivity Troponin T
From baseline to month 6
Change from baseline to month 6 of RBP4
大体时间：From baseline to month 6

RBP4 = Retinol Binding Protein 4
From baseline to month 6
Signs of cardiac remodeling from baseline to month 6
大体时间：From baseline to month 6

These signs will be measured by echocardiogram
From baseline to month 6
Change from baseline to month 6 in 6MWD
大体时间：From baseline to month 6

The 6-Minute Walk distance (6MWD) measures the total distance that a participant could walk in 6 minutes.
From baseline to month 6
Change from baseline to month 6 in the eGFR
大体时间：From baseline to month 6

eGFR = estimated glomerular filtration rate
From baseline to month 6
Change from baseline to month 6 in UACR
大体时间：From baseline to month 6

UACR = Urinary Albumin Creatinine Ratio
From baseline to month 6
Change from baseline to month 6 in TSH
大体时间：From baseline to month 6

TSH = Thyroid Stimulating Hormone
From baseline to month 6
Change from baseline to month 6 in KCCQ-OS score
大体时间：From baseline to month 6

The Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS) is 23-item questionnaire developed to measure health status and health-related quality of life (QoL) in individuals with heart failure. Items include heart failure symptoms, impact on physical and social functions, and how heart failure impacts QoL.
From baseline to month 6
Change from baseline to month 6 of EQ-5D-5L index score
大体时间：From baseline to month 6

The EuroQol-5-Dimension-5-Level (EQ-5D-5L) includes two parts. In the first part, participants are asked to rate their current health state on 5 dimensions (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with each dimension having five levels of function (1-no problem, 2-slight problem, 3-moderate problem, 4-severe problem, and 5-extreme problem). The second part is a self-rating of current health status on a Visual Analogue Scale (EQ VAS) with endpoints labeled "best imaginable health state" (score of 100) and "worst imaginable health state" (score of 0). The scores from the 5 dimensions are used to calculate the index score.
From baseline to month 6

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

Bayer

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。

一般刊物

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2月13日

初级完成 (估计的)

2027年7月15日

研究完成 (估计的)

2027年7月15日

研究注册日期

首次提交

2025年12月11日

首先提交符合 QC 标准的

2025年12月11日

首次发布 (实际的)

2025年12月22日

研究记录更新

最后更新发布 (实际的)

2026年10月15日

上次提交的符合 QC 标准的更新

2026年10月14日

最后验证

2026年9月24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

  • 23026
  • 2025-521831-35-00 (注册表标识符：CTIS (EU))
  • 2025 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access.

As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.

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

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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