NL-OMON31511已完成4 期
Ribavirin: its dosing regime - Ribados
试验速览
- 阶段
- 4 期
- 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
- •According to standard treatment of HCV with ribavirin. Additional for this study:
- •-Obtained written informed consent
- •-Age above 18 years
- •-Body weight >=70 kg: At a lower body weight, a dose of ribavirin is used (400/600mg a day) that cannot be used in this study.;Main inclusion criteria for standard treatment are:
- •Anti-HCV positivity >6 months
- •Positive HCV-RNA genotype 1 or 4
- •Liver biopsy within one year before start of treatment
- •intention to be treated and participate treatment
排除标准
- •Main exclusioncriteria for the standard treatment are:
- •Pregnancy or intention to get pregnant within the treatment period + 6 months
- •no adequate contraception (for men and women)
- •HIV positivity
- •Active uncontrolled psychiatric disorders and suicidal leanings
- •patients with a history of uncontrolled seizure or other significant CNS dysfunction
- •Chemotherapy, systemic antiviral treatment during 6 months prior to study entry
- •Other serious disease
研究者
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