Calendario›JAZZ›ODSH at 0.125 mg

ODSH at 0.125 mg

Pilot/Ph I Safety and Efficacy of ODSH in Protein Losing Enteropathy Secondary to Single Ventricle Palliative Surgery

Ensayo de Jazz Pharmaceuticals plc en Protein Losing Enteropathy (del registro, en inglés).

Fase

Fase 1

Estado

Interrumpido

Participantes

5

previstos

Centros

4

Fin del objetivo primario

feb 2012

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en jul 2010.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Extremely slow accural due to rarity of medical condition studied.».

Qué mide

Clinical improvement of PLE symptoms and signs. (Day 4 after 96 hours of IV continuous infusion of ODSH) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroProtein Losing Enteropathy (PLE) is a serious medical condition that may develop in children and adults with congenital heart disease for which a palliative procedure known as the "Fontan procedure" has been performed. The loss of serum proteins into the gastrointestinal tract that is associated with PLE can cause serious symptoms and life-threatening complications. A number of clinical studies have suggested that heparin administration can have clinical benefit in children with PLE, however the risk of bleeding associated with the administration of heparin is an important concern and commonly limits its administration. ODSH is a desulfated heparin with minimal anticoagulation properties but which, in pre-clinical studies, appears to have the potential to replace heparin and greatly reduce the risk of bleeding. This open label study is to assess the safety and evidence of therapeutic effect of the administration of ODSH as a 4-day continuous intravenous infusion in patients with an exacerbation of their PLE.

Más ensayos de JAZZ

Todos los de JAZZ, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01161641), actualizada en dic 2021.