Early Detection of Fabry Disease

NCT ID: NCT05106764

Last Updated: 2026-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-30

Study Completion Date

2025-12-16

Brief Summary

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The main aim of this study is early detection of FD using real-world data for the development of advanced natural language processing methods and to develop a predictive algorithm and to measure the performance of the algorithm in identifying participants with FD.

This study is about using data from hospital Electronic Health Record database from the last 10 years to describe the ranking of participants with FD using multilevel likelihood ratios and to validate the algorithm using positive controls. No investigational medicinal product or device will be tested in this study. Hospital electronic health record data will be analyzed for a period of up to 6 months.

Detailed Description

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Conditions

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Fabry Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Retrospective Database Analysis

Data from patient's hospital records of the last 10 years will be collected/extracted retrospectively using epidemiological methods to test the forecasting power of the algorithm.

No intervention

Intervention Type OTHER

This is non-interventional study.

Interventions

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No intervention

This is non-interventional study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* In-patient or out-patient datasets of the participating hospital in the last 10 years
* Participants at any age Positive controls: a subset of all participant hospital records that includes the participants with confirmed FD.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Universitätsklinikum Erlangen Kinder- und Jugendklinik

Erlangen, , Germany

Site Status

Universitätsklinikum Erlangen Neurologische Klinik

Erlangen, , Germany

Site Status

Universitätsmedizin Mainz Villa Metabolica Zentrum für Kinder- und Jugendmedizin

Mainz, , Germany

Site Status

Countries

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Germany

Related Links

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https://clinicaltrials.takeda.com/study-detail/61bcf691f571d4002a64b4b7

To obtain more information on the study, click here/on this link

Other Identifiers

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TAK-675-4011-1

Identifier Type: -

Identifier Source: org_study_id

FLAGGING FD-1

Identifier Type: OTHER

Identifier Source: secondary_id

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