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临床试验/EUCTR2011-002793-23-IT
EUCTR2011-002793-23-IT进行中(未招募)不适用

A Phase 3 Evaluation of BMS-790052 in Combination with Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Subjects with Chronic Hepatitis C Genotypes 1 and 4

BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO0 个研究点目标入组 557 人开始时间: 2012年3月2日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
557

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 chronically infected with HCV Genotype 1 or 4. • HCV RNA viral load of = 10,000 IU/mL. • No previous exposure to an interferon formulation, RBV or HCV direct antiviral agent. • Results of a liver biopsy obtained within three years prior to enrollment to demonstrate the absence of cirrhosis. Subjects with compensated cirrhosis are permitted, however, and any prior biopsy is permitted.
  • 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 535
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 22

排除标准

  • Evidence of decompensated liver disease • Documented or suspected HCC • Positive for HBsAg or HIV-1/HIV-2 antibody at screening

研究者

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