THRIVE-3 - Clinical Trial
¿Cuál es el Propósito de este estudio?
This study needs two overnight stays to give a special medicine called choline and to make sure it is safe. It also includes ten visits to the clinic over about sixteen months.
¿Cuál es la Condición que se está estudiando?
Home TPN, choline supplementation
¿Quién puede participar en el Estudio?
Stable home TPN patients
Grupo etario
Adultos
¿Qué Implica?
This study is testing if a special kind of medicine called IV choline is safe and works well for people who get their nutrition through a tube at home. The study also wants to find out which amount of the medicine is best for raising choline levels in the blood to help stop or fix a shortage.
Detalles del Estudio
Título Completo
A Phase 2b/3 Randomized Open-Label Dose-Selection Study with Open-Label Extension and Randomized Double-Blind, Placebo-Controlled Study with Open-Label Extension to Evaluate the Safety and Efficacy of Choline Chloride for Injection (Low Dose and High Dose) Versus Placebo in Adolescents and Adults with Intestinal Failure Receiving Long-Term Parenteral Support
Investigador Principal
Paul E. Wischmeyer, MD
Especialista en anestesiología
Número de Protocolo
IRB:
PRO00117629
Fase
Phase II/III
Estado de inscripción
Abierto para inscripción