The Influence of 5-Aminosalicylates on Thiopurine Metabolite Levels
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To determine the influence of 5-ASA compounds and its metabolites on the 6-TGN level during steady state AZA or 6-MP dosages
研究概览
简要总结
The purpose of this study is to determine the influence of different 5-aminosalicylate concentrations on the metabolism of azathioprine or 6-mercaptopurine in patients with inflammatory bowel disease.
详细描述
Background:
The concomitant use of 5-aminosalicylates (5ASA) next to azathioprine (AZA) or 6-mercaptopurine (6MP) in the treatment of inflammatory bowel disease (IBD) may lead to an increased effectiveness of therapy as higher levels of the active metabolite of AZA/6MP (6-thioguaninenucleotides (6TGNs) are measured.
Objectives:
To determine the influence of 5-ASA compounds and its metabolites on the metabolites of AZA/6MP (6TGNs + 6-methylmercaptopurine (6MMP).
Methods:
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
- Treatment
- 盲法
- Single
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
- 否
入选标准
- •Adult patients, aged between 18 - 70 years
- •Informed consent
- •Diagnosis of CD or UC for at least 6 months (histological and endoscopically confirmed)
- •Steady state AZA of 6-MP use (an unchanged thiopurine regime for at least 4 weeks)
- •Normal liver and kidney function (ALAT / AP / creatinin < 2 x upper normal limit)
- •Quiescent disease (HBI score ≤ 4 for CD or modified TLWI score ≤ 4 for UC)
排除标准
- •Bone marrow suppression (platelets / leucocytes < 1 x lower normal level)
- •Presence of active infection (fever and CRP > 1 x upper normal limit)
- •Anemia (hemoglobin < 6 mmol)
- •Known duodenal Crohn's disease interfering significantly with resorptive area
- •Small bowel surgery interfering significantly with resorptive area
- •Known intolerance to 5-ASA compounds
- •Current use of 5-ASA compounds
- •Use of 5-ASA compounds within the last 30 days
- •Concomitant use of allopurinol, ACE-inhibitors or furosemide
- •Pregnancy, expected pregnancy or lactation within 6 months
结局指标
主要结局
To determine the influence of 5-ASA compounds and its metabolites on the 6-TGN level during steady state AZA or 6-MP dosages
次要结局
- To determine the influence of 5-ASA compounds and its metabolites on the 6-MMP level during steady state AZA or 6-MP dose
- To determine the influence of 5-ASA compounds and its metabolites on the 6-TGMP, 6-TGDP and 6-TGTP levels during steady state AZA or 6-MP dosages
- To evaluate the safety of co-administrating 5-ASA and AZA or 6-MP in IBD patients