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Brincidofovir

Study to Assess Brincidofovir Treatment of Serious Diseases or Conditions Caused by Double-stranded DNA Viruses

Ensayo de Jazz Pharmaceuticals plc en Virus de ADN bicatenario.

Fase

Fase 3

Estado

Completado

Participantes

210

previstos

Centros

37

Fin del objetivo primario

dic 2012

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en dic 2010.

Qué mide

Numero de Sujetos que Tuvieron una Reduccion Sostenida y Significativa en la Carga Viral en Plasma del Virus ADN bicatenario Primario (3 meses)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis was a multicenter, open-label study of oral brincidofovir (BCV) treatment of serious disease or conditions caused by double-stranded DNA (dsDNA) virus(es). Subjects received either a weight-based or a fixed dose of oral BCV once weekly (QW) or twice weekly (BIW) for up to 3 months until clinical disease was resolved or stabilized and/or viral DNA by polymerase chain reaction testing was negative for 4 consecutive weeks, whichever was longer. Under the first protocol amendment, adults and adolescents (≥13 years) received 200 mg or 300 mg BCV BIW (not to exceed 4 mg/kg total weekly dose) depending on the difficulty of treating their disease (i.e., Group 1 or Group 2, respectively), and pediatric subjects (≤12 years) received 4 mg/kg BCV BIW. Under the second protocol amendment, adults and adolescents (≥13 years), regardless of viral infection/disease, had a maximum weekly dose of 200 mg, i.e., 200 mg QW or 100 mg BIW; not to exceed 4mg/kg total weekly dose. Pediatric subjects (≤12 years), regardless of viral infection/disease, had a maximum weekly dose of 4 mg/kg, i.e., 4 mg/kg QW or 2 mg/kg BIW; not to exceed 200 mg.

Más ensayos de JAZZ

Todos los de JAZZ, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01143181), actualizada en jul 2021.