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临床试验/EUCTR2009-011786-80-IT
EUCTR2009-011786-80-IT进行中(未招募)不适用

Randomized, Controlled Phase 2a/b Study of the Efficacy and Safety of PEG-rIL-29 Administered in Combination with Ribavirin to Treatment-Naive Subjects with Chronic Hepatitis C Virus Infection - ND

ZYMOGENETICS, INC.0 个研究点目标入组 600 人开始时间: 2010年4月7日最近更新:
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
600

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. Males or females between the ages of 18 and 70 years, inclusive, at the time of signing informed consent. 2. No prior therapy for chronic HCV, other than up to 2 weeks of single-agent therapy with a direct-acting antiviral agent, including but not limited to, a protease or polymerase inhibitor. 3. Genotype 1, 2, 3, or 4 HCV RNA. [...]
  • 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
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1. Mixed genotype HCV infection. 2. Current or prior history of decompensated liver disease, including any of the following: current or prior history of encephalopathy of any grade, current or prior history of variceal bleeding, current or prior history of ascites, total serum bilirubin >1.5 mg/dL (unless due to Gilbert s disease), albumin <3.5 g/dL, or INR >1.2 3. Currently lactating or breast-feeding . [?]

研究者

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