Calendario›GILD›Liposomal amphotericin B

Liposomal amphotericin B

Ambisome and Management of Culture-negative Neutropenic Fever Unresponsive to Antibiotics

Ensayo de GILEAD SCIENCES, INC. en Febrile Neutropenia (del registro, en inglés).

Fase

Fase 4

Estado

Interrumpido

Participantes

20

previstos

Centros

1

Fin del objetivo primario

abr 2008

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en mar 2007.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Unable to recruit subjects in the Turkey site.».

Qué mide

PK Profile of the dosing regimen under study (AUC, Cmax, Cmin, and etc.) (throughout) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroAdministration of a single high dose (10 mg/kg) of AmBisome® no later than 72 hours after ARNF onset followed by two 5 mg/kg doses on days 2 and 5 may provide sustained tissue levels of amphotericin B that are as mycologically effective as those provided after administering the standard daily dose of 3 mg/kg/day. The new dosing regimen is anticipated to be equally clinically effective compared with the standard AmBisome® regimen when given for the duration of neutropenic fever in patients with ARNF. In addition, the degree and incidence of nephrotoxicity are predicted to be lower with the 3 sequential dose regimen compared to daily dosing with 3 mg/kg because of the lower cumulative dosage (20 mg/kg versus 42 mg/kg, respectively), which is 1 contributing factor for the development of acute renal failure. Furthermore, the lower cumulative dose may be a cost-effective strategy for the treatment of patients with ARNF.

Más ensayos de GILD

Todos los de GILD, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00421187), actualizada en mar 2011.