A Study of Agalsidase Alfa Enyzme Replacement Therapy in Chinese Children and Adults With Fabry Disease
NCT ID: NCT07187440
Last Updated: 2026-01-02
Study Results
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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RECRUITING
200 participants
OBSERVATIONAL
2025-11-01
2028-11-30
Brief Summary
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The main aim of this study is to learn more about the treatment with Replagal® in Chinese children and adults with Fabry disease. The study aims to assess the heart and kidney function in people with Fabry disease who are routinely treated with Replagal®. Other aims are to learn about the change in heart and kidney function, impact on quality of life, how the treatment with Replagal® works for people with Fabry Disease, and how safe the treatment with Replagal® is in routine real-world settings.
Participants will receive with Replagal® per the routine treatment settings in China. No study-specific visits to the clinical are scheduled.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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All Participants
Participants with Fabry disease will receive enzyme replacement therapy (ERT) with agalsidase alfa under routine clinical practice settings.
No intervention
This is a non-interventional study
Interventions
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No intervention
This is a non-interventional study
Eligibility Criteria
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Inclusion Criteria
* Participant is greater than or equal to (\>= 7) years old.
* Participant with confirmed diagnosis of Fabry disease (by investigator).
* Participant never received or has received ERT (agalsidase alfa or agalsidase beta) within 12 weeks at most prior to enrolment.
* Participant who will receive ERT with agalsidase alfa in routine clinical practice settings.
* For \>= 18 years old, participant should sign the informed consent form (ICF); for 8-17 years old, participant and his (her) parents/ legally authorized representative (LAR) should both sign the ICF; for \< 8 years old, participant will give assent and his (her) parents/legally authorized representative should sign the ICF accordingly.
Exclusion Criteria
* Participant has enrolled in Fabry disease interventional clinical trial currently.
* Other situations that the investigator considers not suitable for participation in this study.
7 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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The First Affiliated Hospital Of USTC (AnHui Provincial Hospital)
Hefei, Anhui, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Fuzhou University Provincial Affiliated Hospital
Fuzhou, Fujian, China
The Second Affiliated Hospital ZheJiang University School Of Medicine
Hangzhou, Guangdong, China
ShanTou Central Hospital
Shantou, Guangdong, China
The University Of Hong Kong-ShenZhen Hospital
Shenzhen, Guangdong, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, China
The First Affiliated Hospital With NanJing Medical University(JiangSu Province Hospital)
Nanjing, Jiangsu, China
The First Affiliated Hospital Of Soochow University
Suzhou, Jiangsu, China
The Second Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi, China
Second Hospital Of ShanXi Medical University
Taiyuan, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
TianJin Chest Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TAK-675-4013
Identifier Type: -
Identifier Source: org_study_id
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