NCT07494058Leállítva
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 11.
Megadott ok: 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
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Leállítva
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 232 (tényleges)
- Első benyújtás
- 2026. márc. 20.
- Kezdés
- 2025. dec. 11.
- Elsődleges befejezés
- 2026. júl. 3.
- Fő szponzor
- Takeda
- Betegségek
- Fabry-betegség, Gaucher-kór
- NCT-szám
- NCT07494058
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Egyéb
- 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
Kiket keres a vizsgálat
- 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
Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| - | Mexico City | Mexikó | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.