EUCTR2012-003088-23-IT进行中（未招募）1 期
A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered with Ribavirin (RBV) in Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-II).
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 381
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
入选标准
- •-Males or females 18 - 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 either never received antiviral treatment for hepatitis C infection or has received prior pegIFN/RBV treatment and did not respond -Documentation of cirrhosis (Child Pugh A)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 270
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
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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