Treatment Patterns, Biochemical Profiles and Clinical Outcomes in Adults With X-Linked Hypophosphatemia (IBIS XLH)
2026年8月26日 更新者：Novo Nordisk A/S
Treatment Patterns, Biochemical Profiles and Clinical Outcomes in Adults With X-Linked Hypophosphatemia - A Prospective Observational Cohort Study - IBIS XLH
The purpose of this study is to better understand how X-linked hypophosphatemia (XLH) affects the body and daily life.
Phosphate levels are critical in managing XLH, we aim to study how these levels change in patients taking burosumab and how they relate to bone health, overall disease burden and XLH-related conditions.
研究概览
研究类型
观察性的
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。
学习地点
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Ontario
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Oakville、Ontario、加拿大、L6M 1M1
- Bone Research and Education Centre
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Berlin、德国、13353
- Charite Campus Virchow
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Göttingen、德国、37075
- Endokrinologikum Goettingen
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Wuezburg、德国、97074
- Universitat Wurzburg Koenig-Ludwig-Haus
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Milan、意大利、20145
- Istituto Auxologico Italiano
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Padova、意大利、35128
- Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia
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Rome、意大利、00128
- Fondazione Policlinico Universitario Campus Bio-Medico
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Florence
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Sesto Fiorentino、Florence、意大利、50019
- Office of Francesco Di Costanzo, MD
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Osaka、日本、553-0003
- Japan Community Healthcare Organization Osaka Hospital
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Osaka、日本、530-0052
- Iseikai International General Hospital
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Fukuoka
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Fukuoka、Fukuoka、日本、814-0180
- Fukuoka University - Fukuoka University Hospital
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Okayama-ken
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Okayama、Okayama-ken、日本、700-0013
- Okayama Saiseikai Outpatient Center Hospital
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Tokyo
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Bunkyo-ku、Tokyo、日本、113-8655
- The University of Tokyo Hospital
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Le Kremlin、法国、94275
- CHU de Bicêtre
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Paris、法国、75014
- Hopital Cochin - APHP
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New South Wales
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St Leonards、New South Wales、澳大利亚、2065
- Northern Sydney Cancer Centre-Royal North Shore Hospital (RNSH)
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Westmead、New South Wales、澳大利亚、2145
- Westmead Hospital
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Victoria
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Clayton、Victoria、澳大利亚、3168
- Monash University - Monash Medical Centre (MMC)
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Connecticut
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New Haven、Connecticut、美国、06510
- Yale University School Of Medicine
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Indiana
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Indianapolis、Indiana、美国、46202-5271
- Indiana University Hospital
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Ohio
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Columbus、Ohio、美国、43203
- The Ohio State University Wexner Medical Center (OSUWMC) - CarePoint East
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Tennessee
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Nashville、Tennessee、美国、37232-8148
- Vanderbilt University Medical Center
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Leiden、荷兰、2333 ZA
- Leiden University Medical Center (Leids Universitair Medisch Centrum (LUMC))
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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
接受健康志愿者
不
取样方法
非概率样本
研究人群
Adults with XLH, confirmed genetically or clinically as determined by the investigator, who have been treated with burosumab for at least 90 days prior to the screening/baseline visit and whose treatment is still ongoing.
Participants will be followed for a maximum of three years, continuing until end of trial visit, withdrawal of consent or loss to follow-up, whichever occurs first.
描述
Inclusion Criteria:
- Informed consent obtained before any trial-related activities, i.e., any procedure related to recording of data according to the protocol.
- Male or female and aged 18-64 years (both inclusive) at the time of signing informed consent.
- Diagnosis of congenital XLH, confirmed genetically or clinically as determined by the investigator, supported by documentation.
- Participants have been treated with burosumab for at least 90 days prior to the screening/baseline visit and treatment is still ongoing.
- Participant confirms ability and willingness to attend visits according to routine clinical care and mandatory assessments at the site.
Exclusion Criteria:
- Previous rescreening for this trial.
- Current participation in any interventional clinical trial. Participation in another non-interventional trial, such as a patient registry trial, is permitted.
- Any condition not associated with XLH, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
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
队列和干预
团体/队列 |
干预/治疗 |
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Adults with XLH
Adults with XLH, confirmed genetically or clinically as determined by the investigator, who have been treated with burosumab for at least 90 days prior to the screening/baseline visit and whose treatment is still ongoing will be followed for a maximum of three years, continuing until end of trial visit, withdrawal of consent or loss to follow-up, whichever occurs first.
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未给予治疗
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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 |
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Average Trough Serum Phosphate Concentration
大体时间：From baseline to last assessment (Up to 3 years)
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Average trough serum phosphate concentration, defined as the area under the concentration-time curve (AUC) divided by the total duration of the assessment period (AUC divided by time).
Measured in milligrams per deciliter (mg/dL).
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From baseline to last assessment (Up to 3 years)
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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。
调查人员
- 研究主任：Clinical Transparency dept. 2834、Novo Nordisk A/S
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 (估计的)
2026年7月7日
初级完成 (估计的)
2030年7月7日
研究完成 (估计的)
2030年7月7日
研究注册日期
首次提交
2026年5月19日
首先提交符合 QC 标准的
2026年5月19日
首次发布 (实际的)
2026年5月26日
研究记录更新
最后更新发布 (实际的)
2026年8月28日
上次提交的符合 QC 标准的更新
2026年8月26日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- NN8661-8325
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
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
药物和器械信息、研究文件
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.