NCT00749138已完成1 期
Fourteen Day Safety of Low-Dose Tamoxifen in Patients With Chronic Hepatitis C Who Have Failed Standard Medical Therapy
Bader, Ted, M.D.1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2008年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- No significant changes in ALT or total bilirubin
研究概览
简要总结
A short 14 day phase 1 study examining 6 monotherapy doses of oral tamoxifen for safety in chronic HCV patients who have failed standard treatment of peginterferon and ribavirin.
详细描述
Six different dosages of tamoxifen will be given for 14 days with safety and viral loads being measured.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCV RNA positive.
- •failed standard therapy
排除标准
- •Cirrhosis on biopsy
- •Severe medical or psychiatric conditions that would make the evaluation difficult
- •Tamoxifen is a pregnancy category D drug so pregnant women must be excluded.
- •Patients with coumadin cannot be used from a drug interaction.
- •Active use of alcohol or illegal substances -
研究组 & 干预措施
tamoxifen
Experimental
open label giving of tamoxifen
干预措施: tamoxifen (Drug)
结局指标
主要结局
No significant changes in ALT or total bilirubin
时间窗: 14 days
次要结局
- HCV RNA reduction(14 days)
研究者
研究点 (1)
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