EUCTR2006-003404-19-NL进行中（未招募）不适用
Ribavirin: its dosing regime. - Ribados
utrim0 个研究点开始时间: 2007年4月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •The inclusion criteria for the accepted standard treatment, which are:
- •-Anti-HCV positivity > 6 months
- •-Positive HCV-RNA genotype 1 or 4
- •-Liver biopsy within one year before the start of therapy
- •-Intention to be treated and participate treatment
- •Additional inclusion criteria for this study:
- •-Obtained written informed consent
- •- Age above 18 years
- •- Body weight > 75 kg
- •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
- •The exclusion criteria for the accepted standard treatment, which are:
- •-Pregnancy or intention to get pregnant within the treatment period and up to 6 months after discontinuation of therapy, no adequate contraception, lactation
- •-Men not practicing or willing to practice acceptable methods of contraception during the treatment period and up to 6 months after discontinuation of therapy
- •-Life expectancy <1 year
- •-Child Pugh B or C
- •-Creatinin > 150 µmol/l or > 1.70 mg/dl
- •Hemoglobin < 6.5 mmol/l or 10.5 g/dl,
- •White Blood Cells < 2.5 x 109/l,
- •neutrophil < 1.5 x 109/l,
- •platelet count < 70 x 109/l
- •-HIV positivity
- •-Chemotherapy, systemic antiviral treatment during the six months prior to study entry
- •-Other serious disease (e.g. malignancy, uncontrolled myocardial disease or severe arrhythmias)
- •-Active uncontrolled psychiatric disorders and suicidal leanings
- •-Patients with a history of uncontrolled seizure or other significant CNS dysfunction
- •-Any condition which in the opinion of the (co-)investigator might interfere with the evaluation of the study objectives
研究者
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