EUCTR2012-003463-22-ES进行中（未招募）不适用
MAGNITUDE - A Phase 3 Evaluation of the Safety and Efficacy of Lambda/RBV/DCV in Treatment Naïve Subjects with Chronic HCV Infection, who have Underlying Mild or Moderate Hemophilia or Patients who are Prior Relapsers to Pegylated interferon alfa/RBVRevised Protocol 01, incorporating Amendment 02 and Administartive Letter 01+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0, dated 11-Sep-12) - MAGNITUDE
相关药物
试验速览
- 阶段
- 不适用
- 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:
- •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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A Phase 3 Evaluation of the Safety and Efficacy of Lambda/RBV/DCV in Treatment Naïve Subjects with Chronic HCV Infection, who have Underlying Mild or Moderate Hemophilia or Patients who are Prior Relapsers to Pegylated interferon alfa/RBVChronic Hepatitis C Virus Infection (Genotype 1b, 2, 3, 4)MedDRA version: 14.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2012-003463-22-NLBristol-Myers Squibb International Corporation130
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A Phase 3 Evaluation of the Safety and Efficacy of Lambda/RBV/DCV inTreatment Naïve Subjects with Chronic HCV Infection, who haveUnderlying Mild or Moderate Hemophilia or Patients who are PriorRelapsers to Pegylated interferon alfa/RBVChronic Hepatitis C Virus Infection(Genotype 1b, 2, 3, 4)MedDRA version: 14.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2012-003463-22-ITBRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO130
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