EUCTR2012-003088-23-BE进行中（未招募）不适用
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 Coadministeredwith Ribavirin (RBV) in Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-II)
试验速览
- 阶段
- 不适用
- 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
- 性别
- All
入选标准
- •1. Male or female and age is between 18 and 70 years, inclusive, at time of Screening.
- •2. Chronic HCV-infection prior to study enrollment. Chronic HCV-infection is defined as one of the following:
- •- Positive for anti-HCV antibody (Ab) or HCV RNA at least 6 months before Screening, and
- •- positive for HCV RNA and anti-HCV Ab at the time of Screening; or Positive for anti-HCV Ab and HCV RNA at the time of Screening with a liver biopsy consistent
- •with chronic HCV-infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis C disease).
- •3. Screening laboratory result indicating HCV genotype 1-infection.
- •4. Compensated cirrhosis defined as a Child-Pugh Score of = 6 at Screening
- •5. Subject has plasma HCV RNA level > 10,000 IU/mL at Screening.
- •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 342
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 38
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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