A Study of Home vs Hospital Treatment in People With Fabry, Gaucher or Hunter Conditions in Mexico (NCT07494058) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Study of Home vs Hospital Treatment in People With Fabry, Gaucher or Hunter Conditions in Mexico
Mexico222 participantsStarted 2025-12-11
Plain-language summary
During the COVID-19 pandemic, home treatment for conditions such as Fabry, Gaucher or Hunter became important because it is easier for people to stick to their treatment if medicines that need to be given as infusion (called intravenous or IV treatment) can be given at home or somewhere close to home. Additionally, many of the hospitals that provide infusions are centralized in Mexico.
The main aim of the study is to find out whether people with Fabry, Gaucher or Hunter condition are more likely to continue and follow their treatment properly (called 'treatment adherence') when they receive it at home compared to when they receive it at a hospital. Other aims are to understand the factors that can influence treatment adherence, to learn about any regional differences in Mexico and to understand any medical problems with either treatment (home or hospital).
No treatment will be given during this study. Only already existing data will be reviewed during this study.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Participants who met the inclusion criteria of the "Modular infusion" program
* Confirmed diagnosis of Fabry disease, Gaucher disease, or Hunter syndrome
* Confirmatory diagnostic test
* Referral to the PSP from the treating physician
* Original PSP informed consent and
* Privacy notice signed
* Participants who met the inclusion criteria of the "Hospital infusion" program
* Confirmed diagnosis of Fabry disease, Gaucher disease, or Hunter syndrome
* Confirmatory diagnostic test
* Referral to the PSP from the treating physician
* Original PSP informed consent and
* Privacy notice signed
* Agreement that their anonymized information will be used for research purposes
Exclusion Criteria
* Participants who do not agree or withdraw his/her explicit consent for research purposes may have the right to withdraw; however, once their data has been integrated into the database, it is no longer identifiable by any participant in the research team.
* Discontinuation of Participants
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ratio of Treatment Adherence by Infusion Setting (Modular Infusion versus Hospital Infusion)