EUCTR2011-001180-53-ES进行中（未招募）1 期
A Phase III, randomized, double-blind trial to evaluate the efficacy, safety and tolerability of TMC435 vs. telaprevir, both in combination with PegIFN?-2a and ribavirin, in chronic hepatitis C genotype-1 infected subjects who were null or partial responders to prior PegIFN? and ribavirin therapy. - NA
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 763
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
- •- Genotype 1 hepatitis C infection (confirmed at screening)
- •- patient must have had a liver biopsy within 3 years before screening (or between the screening and baseline visit) showing chronic hepatitis C infection
- •- patient must have had at least 1 documented previous course of treament with PegINF?-2a or PegINF?-2b in combination with RBV (at least 12 weeks for null responder and 20 for partial responder)
- •- Plasma HCV RNA of >10,000 IU/mL at screening
- •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 27
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 27
排除标准
- •- Infection with HIV or non genotype 1 hepatitis C
- •- liver disease not related to hepatitic C infection
- •- hepatic decompensation
- •- significant laboratory abnormalities or other active diseases
- •- previous CHC treatment other than PegIFN and RBV
- •- pregnant or planning to become pregnant
研究者
相似试验
进行中（未招募）
不适用
TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFa-2a and Ribavirin in Chronic Hep C Patients who Were Null orPartial Responders to Prior PegINFa-2a and Ribavirin Therapy.EUCTR2011-001180-53-GRTibotec Pharmaceuticals744
进行中（未招募）
不适用
TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFa-2a and Ribavirin in Chronic Hepatitis C Patients who Were Null or Partial Responders to Prior PegINFa-2a and Ribavirin TherapyHepatitis C Virus (HCV) genotype-1 infectionMedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-001180-53-HUTibotec Pharmaceuticals744
进行中（未招募）
不适用
TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFa-2a and Ribavirin in Chronic Hepatitis C Patients who Were Null or Partial Responders to Prior PegINFa-2a and Ribavirin TherapyEUCTR2011-001180-53-DKJanssen R&D Ireland744
进行中（未招募）
不适用
TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFa-2a and Ribavirin in Chronic Hepatitis C Patients who Were Null or Partial Responders to Prior PegINFa-2a and Ribavirin TherapyHepatitis C Virus (HCV) genotype-1 infectionMedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-001180-53-BGJanssen R&D Ireland744
进行中（未招募）
不适用
TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFa-2a and Ribavirin in Chronic Hepatitis C Patients who Were Null or Partial Responders to Prior PegINFa-2a and Ribavirin TherapyHepatitis C Virus (HCV) genotype-1 infectionMedDRA version: 16.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-001180-53-DEJanssen R&D Ireland744