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New study tracks Real-World impact of fabry treatment in china

NCT ID NCT07187440

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 200 Chinese children and adults with Fabry disease who are receiving routine treatment with Replagal (agalsidase alfa). The goal is to see how the therapy affects heart and kidney function over time, as well as quality of life and safety. Participants continue their normal care without extra study visits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants with Fabry disease who receive ERT with agalsidase alfa in routine clinical practice settings in China.

Ages

7 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria Participants who meet all of the following criteria are eligible for this study: * 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 will be excluded if they have documented New York Heart Association (NYHA) functional Class IV heart failure symptoms (Implantable cardioverter-defibrillator \[ICD\] implanted excluded), third-degree atrioventricular block (ICD implanted excluded), acute myocardial infarction within the last 3 months and severe stroke (NIH Stroke Scale \[NIHSS\] \>= to 21). * Participant has enrolled in Fabry disease interventional clinical trial currently. * Other situations that the investigator considers not suitable for participation in this study.

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Conditions

The condition(s) this trial relates to.

Fabry disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fabry disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    18 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Affiliated Drum Tower Hospital, Medical School of Nanjing University

    RECRUITING

    Nanjing, Jiangsu, 210008, China

  • Fuzhou University Provincial Affiliated Hospital

    RECRUITING

    Fuzhou, Fujian, 350001, China

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100730, China

  • Peking University First Hospital

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, 100034, China

  • Peking University Third Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100191, China

  • Second Hospital Of ShanXi Medical University

    NOT_YET_RECRUITING

    Taiyuan, Shanxi, '030001, China

  • ShanTou Central Hospital

    RECRUITING

    Shantou, Guangdong, 515031, China

  • The First Affiliated Hospital Of Soochow University

    RECRUITING

    Suzhou, Jiangsu, 215006, China

  • The First Affiliated Hospital Of USTC (AnHui Provincial Hospital)

    NOT_YET_RECRUITING

    Hefei, Anhui, 230001, China

  • The First Affiliated Hospital With NanJing Medical University(JiangSu Province Hospital)

    NOT_YET_RECRUITING

    Nanjing, Jiangsu, 210029, China

  • The First Affiliated Hospital of Xi 'an Jiaotong University

    NOT_YET_RECRUITING

    Xi'an, Shaanxi, 710061, China

  • The Second Affiliated Hospital ZheJiang University School Of Medicine

    NOT_YET_RECRUITING

    Hangzhou, Guangdong, 310009, China

  • The Second Affiliated Hospital of Harbin Medical University

    NOT_YET_RECRUITING

    Harbin, Heilongjiang, 150086, China

  • The Second Affiliated Hospital of Xi 'an Jiaotong University

    RECRUITING

    Xi'an, Shaanxi, 710004, China

  • The Second Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, '050000, China

  • The University Of Hong Kong-ShenZhen Hospital

    NOT_YET_RECRUITING

    Shenzhen, Guangdong, 518053, China

  • TianJin Chest Hospital

    NOT_YET_RECRUITING

    Tianjin, Tianjin Municipality, 300222, China

  • West China Hospital of Sichuan University

    NOT_YET_RECRUITING

    Chengdu, Sichuan, 610041, China

More trials for these conditions

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