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)
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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