NCT07494058Terminated
A Study of Home vs Hospital Treatment in People With Fabry, Gaucher or Hunter Conditions in Mexico
Real-world Evidence of Modular Infusion Model in Lysosomal Disease: A Retrospective Observational Comparative Cohort Study From PSP (Patient Support Program) Data in Mexico
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Reason given: Study was terminated early due to structural and methodological limitations identified in the primary data sources impacting validity, completeness, and clinical robustness of the expected results
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Study type
- Observational
- Enrollment
- 232 (actual)
- First submitted
- 20 Mar 2026
- Start date
- 11 Dec 2025
- Primary completion date
- 3 Jul 2026
- Lead sponsor
- Takeda
- Diseases
- Fabry disease, Gaucher disease
- NCT number
- NCT07494058
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - | Mexico City | Mexico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.