NCT00484328已完成4 期
Ribavirin, Its Dosing Regime
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The pharmacokinetics of ribavirin at different dosage regimes, measured by the area under the curve of the concentration-time graph
研究概览
简要总结
The purpose of this study is to determine if the medicines for chronic hepatitis C can be taken once daily, instead of twice daily.
详细描述
The standard treatment of patients with chronic hepatitis C infection (HCV) is treatment with ribavirin. Actually, the compliance (2x daily) seems to be a problem. To increase patients' compliance, it is investigated if the total dose of ribavirin can be taken once daily.
The pharmacokinetics of ribavirin at different dosage regimes is investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •body weight at or above 75 kg
排除标准
- •HIV positive
研究组 & 干预措施
1
Experimental
干预措施: Ribavirin (Drug)
2
Experimental
干预措施: Ribavirin (Drug)
结局指标
主要结局
The pharmacokinetics of ribavirin at different dosage regimes, measured by the area under the curve of the concentration-time graph
时间窗: within 24 weeks after enrollment
次要结局
- The tolerability of the treatment at different dosage regimes of ribavirin(24 weeks of treatment)
- The antioxidant capacity in plasma and erythrocytes at different dosing regimes(24 weeks of treatment)
- The effect of ribavirin on the hemolysis(24 weeks of treatment)
- The pharmacokinetics of ribavirin in erythrocytes in the different dosing regimes(24 weeks of treatment)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Effects of Ribavirin on Zidovudine or StavudineHepatitis CHIV InfectionsNCT00021632National Institute of Allergy and Infectious Diseases (NIAID)32
已完成
2 期
High-Dose Ribavirin and Peginterferon to Treat Chronic Hepatitis C Genotype 1Chronic Hepatitis CNCT00735969National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)21
已完成
2 期
A Study of Ribavirin to Treat M4 and M5 Acute Myelocytic LeukemiaAcute Myelocytic LeukemiaNCT00559091Jewish General Hospital18
Unknown
4 期
A Pilot Study to Treat Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 and End-Stage Renal Disease (ESRD)Chronic Hepatitis CEnd Stage Renal DiseaseNCT01731301Liver Institute of Virginia20
已完成
4 期
Concentration-Controlled Ribavirin for the Treatment of Patients With Chronic Hepatitis C Virus InfectionHepatitis C VirusNCT01097395University of Colorado, Denver35