EUCTR2009-009995-11-NL进行中（未招募）不适用
A randomized, adaptive-design dose finding study to assess the antiviral efficacy andsafety of NIM811 administered in combination with Standard of Care (SOC) in relapsed HCV-1 infected patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
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 with documented histology and biochemical results consistent with compensated chronic hepatitis C.
- •o HCV-RNA should be = 4 x 100000 IU/mL at screening.
- •o Male and female subjects from 18 to and including 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 3 months prior to start study(visit 1). Appropriate documentation of viral load will be provided in the patient’s source documentation for verification of relapse status
- •o Platelets counts > 150,000/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 breast-feeding females
- •o women of child bearing potential not willing to use 2 methods of contraception
- •o Hepatic decompensation
研究者
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