A Phase 3, Global, Multicenter, Open-Label Study to Investigate the Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non-severe fibrosis. - MK2

CHU de Clermont-Ferrand0 个研究点目标入组 70 人开始时间: 2017年6月16日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•1 - Willing and able to provide written informed consent
•2 - Male or female, age = 18 years
•3 - Body Mass Index (BMI) = 18 kg/m2
•4 - HCV RNA = 104 IU/mL at Screening
•5- Chronic HCV infection (= 6 months) documented by prior medical history or liver biopsy. Only patients infected by genotype 1b virus will be included.
•6 - Treatment-naïve with no prior exposure to any IFN, RBV, or approved or experimental HCV-specific DAA
•7 – Non severe fibrosis (F < 2) according to Metavir score if a biopsy was performed or elasticity measured by Fibroscan® lower than 9.5 kPa or Fibrotest lower than 0.59 or Fibrometre lower than 0.63 if Fibroscan® cannot be performed.
•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 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•1 - Medical histaru with significant event
•2- Significant abnormal lab results at screening
•3 - Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson’s disease, alfa-1 antitrypsin deficiency, cholangitis)
•4 - Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
•5 - Clinically-relevant alcohol or drug abuse within 12 months of Screening. A positive drug screen will exclude subjects unless it can be explained by a prescribed medication; the diagnosis and prescription must be approved by the investigator

发起方

CHU de Clermont-Ferrand