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Sofosbuvir

A Registry for Adolescent and Pediatric Participants Who Received a Gilead Hepatitis C Virus Direct Acting Antiviral (DAA) in Gilead-Sponsored Chronic Hepatitis C Infection Trials

Ensayo de GILEAD SCIENCES, INC. en Hepatitis C.

Más ensayos de: Hepatitis C.

Fase

no aplica

Estado

Interrumpido

Participantes

461

previstos

Centros

51

Fin del objetivo primario

ene 2023

fecha real

Qué significa cada fase y cada estado.

Estudio observacional. Comenzó en oct 2015.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «The study stopped early because the study objectives were met.».

Qué mide

Growth data as measured by body height (del registro, en inglés) (hasta 5 años)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis Registry will enroll adolescent and pediatric participants who received at least one Gilead Hepatitis C Virus (HCV) direct acting antiviral (DAA) while participating in a Gilead-sponsored chronic hepatitis C clinical trial. The primary objective of this Registry is to determine the long-term safety of anti-HCV regimens in the pediatric population. Secondary objectives of this Registry are to determine whether subsequent detection of HCV RNA in participants who relapse following sustained virologic response (SVR) represents the re-emergence of pre-existing virus, the development of resistance mutations, or whether it is due to re-infection, and to characterize resistance mutations and the persistence of resistance mutations in pediatric participants who did not achieve SVR. Once enrolled, participants will be followed for up to 5 years.

Más ensayos de GILD

Todos los de GILD, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02510300), actualizada en ene 2023.