跳至主要内容
临床试验/EUCTR2012-005522-29-GB
EUCTR2012-005522-29-GB进行中(未招募)不适用

A Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy and Safety of the Combination of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With and Without Ribavirin (RBV) in Treatment-Naïve Adults with Genotype 1a Chronic Hepatitis C Virus (HCV) Infection (PEARL-IV)

AbbVie Deutschland GmbH & Co. KG0 个研究点目标入组 314 人开始时间: 2013年4月12日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
314

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 1a-infection (HCV RNA level greater than or equal to 10,000 IU/mL at screening)
  • Subject has never received antiviral treatment for hepatitis C infection
  • No evidence of liver cirhhosis
  • 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 296
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 18

排除标准

  • Positive screen for drugs or alcohol
  • 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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