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Brincidofovir · AdAPT

The AdAPT Trial; Adenovirus After Allogeneic Pediatric Transplantation

Ensayo de Jazz Pharmaceuticals plc en Adenovirus (del registro, en inglés).

Fase

Fase 2

Estado

Interrumpido

Participantes

29

previstos

Centros

36

Fin del objetivo primario

may 2019

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en dic 2017.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «terminated due to low enrollment rate».

Qué mide

Time-averaged Area Under the Concentration-time Curve for Plasma Adenovirus Viremia (Log10 Copies/mL). (From randomization to 16 weeks post-randomization) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis study was designed to assess the safety, overall tolerability, and antiviral activity of "short course" brincidofovir (BCV) therapy, as compared with current standard of care (SoC), for the treatment of adenovirus (AdV) infections in high-risk (i.e., T cell depleted) pediatric allogeneic hematopoietic cell transplant (HCT) recipients. A virologic response-driven approach to the duration of treatment was to be evaluated, in which subjects randomized to BCV therapy were to be treated until AdV viremia was confirmed as undetectable or until a maximum of 16 weeks of therapy, whichever occurred first. The formulation of BCV used in this study was oral tablet/suspension.

Más ensayos de JAZZ

Todos los de JAZZ, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03339401), actualizada en ene 2021.