跳至主要内容
临床试验/EUCTR2014-000137-22-DE
EUCTR2014-000137-22-DE进行中(未招募)1 期

A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Treatment-Naïve Subjects with Chronic HCV GT1, GT4, GT5, and GT6 Infection - MK-5172 in Combination with MK-8742 in Treatment-Naïve Subjects

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 个研究点目标入组 400 人开始时间: 2014年4月3日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
400

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

  • You are greater than or equal to 18 years of age
  • You have chronic HCV GT1, GT4, GT5, GT6
  • You have had a liver biopsy, Fibroscan or Fibrotest to check for cirrhosis or no cirrhosis
  • You are treatment naïve to all anti-HCV treatment
  • 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 320
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 80

排除标准

  • You have signs of decompensated liver disease
  • You are coninfected with Hepatitis B
  • You have signs of hepatocellular carcinoma or history of malignancy
  • You are taking or plan to take any medication not allowed for this study
  • You have a history of, or signs of, chronic hepatitis not caused by hepatitis C virus
  • You have an exclusionary laboratory value

研究者

相似试验

进行中(未招募)
1 期
Sitagliptin with atorvastatin in patients with type 2 diabetes mellitus who have inadequate glycemic control on metformin monotherapy.Type 2 diabetes mellitusMedDRA version: 14.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
EUCTR2011-003600-20-BGMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.825
进行中(未招募)
不适用
MK-5172 in Combination with MK-8742 with and without Ribavirin (RBV) in HCV patients who failed Prior pegylated interferon (peg-IFN) and RBV treatmentHepatitis C
EUCTR2014-000824-12-FIMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc400
进行中(未招募)
1 期
A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Treatment-Naïve Subjects with Chronic HCV GT1, GT4, and GT6 Infection who are on Opiate Substitution Therapy.MedDRA version: 20.0Level: LLTClassification code 10019751Term: Hepatitis C virusSystem Organ Class: 100000004848Hepatitis C
EUCTR2014-000343-32-DEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co.,301
进行中(未招募)
不适用
Sitagliptin with atorvastatin in patients with type 2 diabetes mellitus who have inadequate glycemic control on metformin monotherapy.Type 2 diabetes mellitusMedDRA version: 15.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
EUCTR2011-003600-20-DEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.825
进行中(未招募)
不适用
MK-5172 in Combination with MK-8742 with and without Ribavirin (RBV) in HCV patients who failed Prior pegylated interferon (peg-IFN) and RBV treatmentMedDRA version: 17.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsHepatitis C
EUCTR2014-000824-12-NLMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc400