EUCTR2012-003463-22-IT进行中(未招募)1 期
MAGNITUDE-A Phase 3 Evaluation of the Safety and Efficacy ofLambda/RBV/DCV in Treatment Naïve Subjects with Chronic HCVInfection, who have Underlying Mild or Moderate Hemophilia or Patientswho are Prior Relapsers to Pegylated interferon alfa/RBV.Revised Protocol 01 Incorporates Amendment 02 and Administrative Letter01 and 02.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 130
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
- Male
入选标准
- •Infection with the hepatitis C virus (HCV) with underlying mild or moderate hemophilia
- •Males 18 years of age and above
- •Have not been previously treated with an interferon
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 117
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 13
排除标准
- •Not infected with the hepatitis C virus (HCV), hepatitis D virus (HDV) or human immunodeficiency virus (HIV) • Do not have a serious liver, psychiatric, blood, thyroid, lung, heart or eye disease • Presence of Bethesda inhibitor
研究者
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