Ribavirin Dose Optimization for the Treatment of Hepatitis C: A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) analysis assay
研究概览
简要总结
Patients for whom treatment with peginterferon plus ribavirin was unsuccessful represent a category of patients for whom there is currently no worthwhile therapeutic alternative.
Several studies have shown that there is a relation between plasma ribavirin concentrations and treatment response. Adequate ribavirin plasma concentrations, especially during the first 12 weeks of treatment, should be associated with a better chance of response to the treatment.
The strategy for this study will be to use a loading dose of ribavirin before beginning the treatment with peg-interferon, thereby allowing for optimal ribavirin concentrations to be reached, and possibly improving the effectiveness of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age > 18 years
- •Chronic hepatitis C and failure of prior treatment with peginterferon plus ribavirin (non-response: HCV-RNA decreased less than 2 logs after 3 months of treatment; relapse: HCV-RNA that becomes positive again after treatment is stopped
- •Compensated hepatic disease (Child-Pugh ≤ 6)
- •Provision by patient of his or her written consent
排除标准
- •Females who are pregnant or lactating will be excluded
- •Renal failure (estimated glomerular filtration rate < 50 ml/min)
- •A contraindication to treatment with peginterferon plus ribavirin (uncontrolled psychiatric illness, pregnancy/nursing/non-use of effective contraceptive method, uncontrolled epilepsy for at least 6 months, heart failure, unstable angina, hemoglobin < 120 g/L, neutrophils < 1,000/mm3, platelets < 50 x 109/L, or any other condition that, in the investigator's opinion, contraindicates use of the treatment)
研究组 & 干预措施
Peg-interferon alpha-2a, Ribavirin
Adult patients with chronic hepatitis C and failure of prior treatment with peginterferon plus ribavirin(non-response or relapse).
This is a pilot study with no control group.
干预措施: Peg-interferon alpha-2a, Ribavirin (Drug)
结局指标
主要结局
Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) analysis assay
时间窗: up to 24 weeks post treatment
Qualitative
次要结局
- Viral Kinetics(up to 24 weeks post treatment)
- Neutrophils(up to 24-48 weeks of treatment)
- Hemoglobin(up to 24-48 weeks of treatment)