NCT01891526已完成不适用
The Pharmacokinetics of a Single Dose of 9-cis-retinoic Acid (Alitretinoin, Toctino®) in Patients With Moderate to Severe Hepatic Insufficiency
University Hospital, Gentofte, Copenhagen1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- A comparison of the metabolisation of retinoic acid in patients with hepatic insufficiency and controls
研究概览
简要总结
To test whether patients with hepatic insufficiency can tolerate one oral dose of 9-cis-retinoic acid and to test whether the metabolism of retinoic acid is altered.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have biopsy verified hepatic insufficiency
- •Medically stable.
- •Ultra sonic examination of lever within the past 3 months
- •No pregnancy documented in women. use of anticonception during study and 1 month after
- •Exclusion criteria:
- •Odd blood counts and samples not related to hepatic disease
- •encephalopathy (> grad II)
- •concomitant treatment with pharmaca that is metabolized by CYP3A4 in the liver.
- •Cardiac disease
- •Kidney disease
- •Esophagal bleeding
- •Severe ascites
- •HIV-positivity
- •Psychiatric disorder
- •pregnancy or lactating women.
排除标准
- 未提供
研究组 & 干预措施
Hepatic patients
patients with hepatic insufficiency
干预措施: 9-cis-retinoic acid (Drug)
Healthy Controls
Healthy adults
干预措施: 9-cis-retinoic acid (Drug)
结局指标
主要结局
A comparison of the metabolisation of retinoic acid in patients with hepatic insufficiency and controls
时间窗: 24 hours
Analysis on samples
次要结局
未报告次要终点
研究者
Frederik Grønlund MD DMSci
MD
University Hospital, Gentofte, Copenhagen
研究点 (1)
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