EUCTR2012-003687-52-AT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 1b Chronic Hepatitis C Virus (HCV) Infection (PEARL-III)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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
- •-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 (Note: Hormonal contraceptives, including oral, topical, injectable or implantable varieties, may not be used during administration of study drugs)
- •-Chronic hepatitis C, genotype 1b-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 360
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
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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