EUCTR2011-005287-21-ES进行中（未招募）1 期
A Long-Term Follow-up Study of Subjects Who Participated in a Clinical Trial in Which Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) Was Administered for the Treatment of Chronic Hepatitis CRevised Protocol Number 02 incorporating Amendments 01 and 02 and Administrative Letter 01
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Received at least one dose of asunaprevir and/or daclatasvir and
- •completed participation in a previous study
- •a) Subjects participating in daclatasvir and/or asunaprevir studies may
- •enroll regardless of virologic response (subjects who received control
- •agents, eg, placebo, will be allowed to participate until unblinded
- •treatment information is released for the parent protocol; at that time
- •subjects will have the option to continue in the study)
- •b) Subjects participating in BMS-914143 (pegylated interferon lambda
- •1a) studies must have HCV RNA >=LOQ at the completion of the
- •posttreatment
- •follow-up period
- •2. Enrolled within 6 months of completing previous study or within 6
- •months of protocol availability at the clinical site
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 960
排除标准
- •1. Treatment with any antiviral or immunomodulatory drug for hepatitis C after completion of the previous study
研究者
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