跳至主要内容
临床试验/EUCTR2012-002019-25-ES
EUCTR2012-002019-25-ES进行中(未招募)不适用

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered with Ribavirin (RBV) in Treatment-Naïve Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-I)

Abbott GmbH & Co. KG0 个研究点目标入组 600 人开始时间: 2013年3月4日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
600

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

  • -Males or females 18 and 70 years old, inclusive
  • -Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control
  • -Chronic hepatitis C, genotype 1-infection (HCV RNA level greater than 10,000 IU/mL at screening
  • -Subject has never received antiviral treatment for hepatitis C infection
  • -No evidence of liver cirhosis
  • 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 540
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 60

排除标准

  • -Significant sensitivity to any drug
  • -Use of contraindicated medications within 2 weeks of dosing
  • -Abnormal laboratory tests
  • -Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus antibody

研究者

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