NCT07494058

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 222 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Lysosomal Disease

Interventions

Type	Name	Description
OTHER	No intervention	This is a non-interventional study.

Timeline

• Start date: 2025-12-11
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: Mexico