Calendario›GILD›Simtuzumab

Simtuzumab

Pilot Study of Simtuzumab in the Treatment of Liver Fibrosis

Ensayo de GILEAD SCIENCES, INC. en Liver Fibrosis (del registro, en inglés).

Fase

Fase 2

Estado

Completado

Participantes

20

previstos

Centros

1

Fin del objetivo primario

ene 2013

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en nov 2011.

Qué mide

Incidence of adverse events on multiple, escalating IV doses of simtuzumab (Through Week 14) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis study will evaluate the safety and tolerability of simtuzumab (GS-6624) in patients with fibrosis of the liver. Up to 20 participants will be enrolled into two sequential cohorts. Cohort 1 will consist of 10 participants who will receive simtuzumab every other week for a total of 3 infusions. Participants in Cohort 2 (10 subjects) will also receive simtuzumab every other week for a total of 3 infusions; the dose will depend on the safety and tolerability of simtuzumab seen in Cohort 1. Participants from both cohorts who have completed the main study will be allowed to continue on simtuzumab treatment for an additional extension period, and will receive up to 13 additional infusions of simtuzumab at a fixed dose of 700 mg for an additional 24 weeks.

Más ensayos de GILD

Todos los de GILD, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01452308), actualizada en ene 2014.