EUCTR2009-009995-11-IT进行中（未招募）不适用
A randomized, adaptive-design dose finding study to assess the antiviral efficacy and safety of NIM811 administered in combination with Standard of Care (SOC) for 12 weeks in relapsed HCV-1 infected patients - ND
适应症
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
- 200
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
- •o Chronic Hepatitis C infection Genotype 1 o HCV-RNA should be ≥ 4 x 105 IU/mL at screening. o Male and female subjects age 18 to 69 years of age, with Chronic Hepatitis C genotype 1 o Recipient of prior long acting interferon (either as PegIntron, Pegasys or albumin-interferon alpha-2b) and ribavirin (either ribavirin or the ribavirin pro-drug, viramidine) treatment for at least 12 weeks, with documented negative serum HCV RNA on treatment , who subsequently becomes serum HCV RNA positive after stopping treatment (?relapser?). Patients must have been off all treatment for at least 12 weeks. Appropriate documentation of viral load will be provided in the patient?s source documentation for verification of relapse status o Platelets counts > 125,000 mm3 o No evidence of cirrhosis by any approved method: transient elastography, liver biopsy or Fibrotest, or any future approved validated method
- •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
- •o Contraindication to either pegylated interferon or ribavirin o Pregnant or lactating females o Hepatic decompensation
研究者
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