EUCTR2014-001496-31-AT进行中（未招募）1 期
A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Coadministered with Ribavirin in Adults with Genotype 4 Chronic Hepatitis C Virus Infection and Cirrhosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
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
- •-Subjects must meet one of the following:
- •* Treatment-naive: Subject has never received antiviral treatment for hepatitis C infection OR
- •* Treatment Experienced (Prior null responders, Partial responders or Relapsers to IFN/RBV);
- •- Chronic HCV genotype 4 infection with cirrhosis.
- •- Subject has plasma HCV RNA level > 1,000 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 155
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •-Positive test result at Screening for Hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
- •-Current enrollment in another interventional clinical study, previous enrollment in this study, or previous use of any protease inhibitor, non-nucleoside polymerase inhibitor, or NS5a inhibitor, either investigational or experimental (including previous exposure to ABT-450 or ombitasvir), or receipt of any investigational product within 6 weeks prior to study drug administration
- •-Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation including ascites, variceal bleeding, or hepatic encephalopathy
- •-Confirmed presence of hepatocellular carcinoma
- •-Any cause of liver disease other than chronic HCV infection
- •-Abnormal laboratory tests.
研究者
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