NCT00849368已完成1 期
Dose-effect Relationship Between Allopurinol, Azathioprine and 6-thioguanine Nucleotide Levels (6-TGN) in Inflammatory Bowel Disease Patients.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Pharmacokinetics: Quantification of trough concentrations of 6-TGN and 6-MMPN in erythrocytes using HPLC at each dose level.
研究概览
简要总结
Main Study Objectives:
The study is conducted to
- evaluate the minimal allopurinol and azathioprine doses that, in combination, produce therapeutic 6-TGN levels
- evaluate the safety and tolerability of the different allopurinol/azathioprine dose levels
- assess if concomitant allopurinol affects TPMT activity
- assess the clinical efficacy of concomitant allopurinol-azathioprine therapy in the included patients
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Azathioprine / Allopurinol
Experimental
Single arm study: Dose escalations as described.
干预措施: Azathioprine / Allopurinol (Drug)
结局指标
主要结局
Pharmacokinetics: Quantification of trough concentrations of 6-TGN and 6-MMPN in erythrocytes using HPLC at each dose level.
时间窗: three times per cycle
次要结局
- Dose escalation: Assessment of the percentage of patients who are in the desired therapeutic range on day 23-25 and on day 26-28 of each dose level.(once per cycle)
- Efficacy: Change in disease activity score in relationship to the dose level attained.(once per cycle)
- TPMT activity assessment(once per cycle)
- Safety and Tolerability: Medical history, adverse events and well-being; laboratory screen, physical examination, vital functions: blood pressure, heart rate, body temperature(screening, up to three times per cycle, follow-up)
研究者
Alexander Jetter
PD Dr. med.
University of Zurich
研究点 (1)
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