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Iohexol

A Study of Renal Function in Treatment-naïve, Young Male Patients With Fabry Disease

Ensayo de Sanofi en Fabry Disease (del registro, en inglés).

Fase

Fase 1

Estado

Interrumpido

Participantes

39

previstos

Centros

22

Fin del objetivo primario

sep 2016

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en may 2013.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Enrollment period not extended and screening stopped for slow recruitment and in accordance with provisions of the protocol. Not linked to any safety concern».

Qué mide

Glomerular Filtration Rate Estimated from Serum Creatinine (eGFR) (del registro, en inglés) (del dia 1 a la semana 8)

Cómo lo describe el promotor

En el documentoEn inglés, del registroNo investigational drug will be administered in this study for the treatment of Fabry disease. This will be a multicenter, multinational, non-treatment, cross-sectional study of young male patients with Fabry disease who have not yet initiated interventional treatment for this disease. The study will consist of a screening visit(s), a clinical investigation visit(s), and a follow-up phone contact. The objectives of the study are: * To document renal function and other Fabry disease manifestations across age in treatment-naïve, young male patients with Fabry disease. * To provide a reference group for comparison with interventional clinical trials of Fabry disease. The duration of each patient's participation in the study, inclusive of the screening visit and follow-up phone contact, will be approximately 12 weeks.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01839526), actualizada en dic 2020.