EUCTR2014-000824-12-NL进行中（未招募）不适用
A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Subjects who have Failed Prior Treatment with Pegylated Interferon and Ribavirin (P/R) with Chronic HCV GT1, GT4, and GT6 Infection
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc0 个研究点目标入组 400 人开始时间: 2014年5月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 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
- •1.Be =18 years of age on day of signing informed consent.
- •2.HCV RNA (= 10,000 IU/mL in peripheral blood) at the time of screening.
- •3.Have documented chronic HCV GT1, GT4, or GT6
- •4.Have had a liver biopsy, Fibroscan, or Fibrotest to check for cirrhosis
- •5.Have a previous HCV treatment status that is of non-response, partial response or treatment relapse
- •6.For HIV-1 co-infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit
- •7.For HIV-1 co-infection CD4+ T-cell count > 200 cells/mm3 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 350
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1.Has evidence of decompensated liver disease
- •2.Is coinfected with hepatitis B virus (e.g. HBsAg positive).
- •3.Has previous direct acting antiviral treatment.
- •4.Has signs of hepatocellular carcinoma or history of malignancy
- •5.Is taking or plans to take (a) any HIV therapy, or other medication not allowed for the study
- •6.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 disordersEUCTR2011-003600-20-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 CEUCTR2014-000824-12-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 CEUCTR2014-000343-32-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 disordersEUCTR2011-003600-20-DEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.825
进行中（未招募）
1 期
MK-5172 in Combination with MK-8742 in Treatment-Naïve SubjectsMedDRA version: 17.0Level: LLTClassification code 10019751Term: Hepatitis C virusSystem Organ Class: 100000004848Hepatitis CEUCTR2014-000137-22-DEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.400