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GS-9450

Efficacy and Safety Study of GS-9450 Treatment for 6 Months in Patients With Chronic Hepatitis C Virus Infection

Ensayo de GILEAD SCIENCES, INC. en HCV Infection (del registro, en inglés).

Fase

Fase 2

Estado

Interrumpido

Participantes

307

previstos

Centros

73

Fin del objetivo primario

abr 2010

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, cuádruple ciego. Comenzó en may 2009.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Reports of significant laboratory abnormalities and adverse events in a number of clinical study participants.».

Qué mide

Histologic response, defined as a >= 2-point decrease in Knodell necroinflammatory score with no concurrent worsening in the Knodell fibrosis score, at Week 24 . (Week 24 on-treatment) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a Phase 2b, randomized, double-blind, parallel-group, placebo-controlled, multicenter study investigating the safety, tolerability and efficacy of two oral doses of GS-9450 in adults with chronic Hepatitis C Virus (HCV). Approximately 240 subjects 18-65 years of age who meet study entry criteria will be randomized (in other words, selected at random, like flipping a coin) to one of three treatment groups (80 subjects per treatment group) as follows:GS-9450 10 mg once daily,GS-9450 40 mg once daily, or matching placebo once daily. Following randomization, subjects will return within seven business days for a Baseline (Day 1) visit, at which time study medication will be dispensed and subjects will enter a 26 week treatment phase. During the treatment phase, subjects will receive study drug once daily for 24 weeks and then taper off of study drug over the following 2 weeks by receiving study drug once every other day for one week and then every 3 days for one week. Following completion of the treatment phase, subjects will enter a 4-week off-treatment follow-up phase.

Más ensayos de GILD

Todos los de GILD, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00874796), actualizada en ene 2014.