Diagnostic Value of Plasma Ribavirin Assay During the Combination Therapy " Pegylated Interferon + Ribavirin " in Chronic Hepatitis C.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- relationship between plasma ribavirin concentration and early virological response
研究概览
简要总结
Investigation of the usefullness of therapeutical drug monitoring of ribavirin for dose adaptation during combination therapy of chronic hepatitis C patients.
The correlation between ribavirin plasma concentration levels at week 4 (steady state) and early virological response (HCV-RNA decay from baseline to week 12) is to be tested in 40 patients approximately.
详细描述
- Background and rational The serum concentrationS of ribavirin commonly range from 1 to 5 in patients during the combination treatment " interferon+ribavirin " (Larrat et al. 2003). However, the bioavailibility of ribavirin is not considered in the current recommendation for this treatment.
The aim of this study is to demonstrate that the adaptation " à la carte " of ribavirin posology according to its serum concentration could improve the efficacy and the tolerance of the hepatitis C combination therapy. 2. Study design This study is a prospective clinical pharmacology trial in patients on combination treatment for a chronic hepatitis C with genotype 1 or 4 virus.
The evaluation will concern the serum ribavirin concentration during the first three months of treatment and its correlation with the evolution of hemoglobin (toxicity marker) or viral load (efficacy marker).
After the 3 months of the study, a adaptation of posology based on serum ribavirin level will be offer to the patients for the rest of the treatment period. A control of the ribavirin level one month after the dose adaptation will be performed. 3. Study treatments This trial is not a treatment evaluation. All the patients will receive the same treatment with PegInterferon alfa-2a and ribavirin according to the registered recommendations for use. 4. Target population The study population will consist of patients with genotype 1 or 4 chronic hepatitis C and for which a combination therapy is indicated. 5. Main selection criteria Patients with chronic hepatitis C related to genotype 1 or 4 virus and for which a combination therapy is needed will be eligible. Patients with co-infection (either VHB or VIH) or with concomitant treatments expected to interact with the endpoints (hemoglobin, viral load, serum ribavirin) will be excluded. 6. Judgement endpoints
There will be intermediate endpoints :
- blood hemoglobin concentration whom reduction during the 4 first weeks of treatment is a marker of toxicicty of the drug (induction of an hemolytic anemiae)
- viral load whom reduction of at least 2 log after 12 weeks of treatment is correlated with the sustained virologic response to treatment
- serum level of ribavirin for which it is expected a correlation with the two previous biological markers
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic hepatitis C related to genotype 1 or 4 virus and for which a combination therapy is needed will be eligible.
排除标准
- •Patients with co-infection (either VHB or VIH) or with concomitant treatments expected to interact with the endpoints (hemoglobin, viral load, serum ribavirin) will be excluded.
结局指标
主要结局
relationship between plasma ribavirin concentration and early virological response
次要结局
- safety
- relationship between plasma ribavirin concentration and hemoglobin drop
- dose effect of ribavirin on ribavirin plasma concentration