NL-OMON31911已完成不适用
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, ASCENDING DOSE STUDY EVALUATING THE SAFETY, TOLERABILITY AND PHARMACOKINETICS AND ANTIVIRAL ACTIVITY OF JTK-652 ADMINISTERED FOR FOUR WEEKS IN SUBJECTS WITH CHRONIC HEPATITIS C INFECTION - JTK-652 proof of concept study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Age : 18-65 yr, inclusive
- •BMI : 18.5-32 kg/m2, inclusive
- •Subjects : males and postmenopausal females with
- •- chronic hepatitis C infection (genotype 1a or 1b, or mixed 1a/1b)
- •- HCV-RNA * 100 KIU/mL
- •- ALAT * 5 times of upper limit of normal (ULN
排除标准
- •1. Evidence of human immunodeficiency virus (HIV) infection (enzyme immunoassay confirmed by Western blot)
- •2. Evidence of chronic hepatitis B virus (HBV) infection (HB surface antigen [HBsAg])
- •3. Evidence of acute hepatitis A infection (hepatitis A IgM+)
- •4. Antiviral therapy for HCV within preceding 6 months (including all types of interferon, ie, standard, pegylated)
- •5. Systemic antiviral, cytotoxic, hepatotoxic, or immunomodulatory therapy within 3 months prior to first dose
- •6. Recent (* 3 months prior to screening) history of alcohol or drug abuse
- •7. Evidence of Child-Pugh B or C liver disease (for Child-Pugh classification see Appendix 9.7)
研究者
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