EUCTR2008-005015-17-NL进行中（未招募）不适用
Effect of N-acetylcysteine on thiopurine related hepatotoxicity in IBD patients - NACTOX
VU university medical centre0 个研究点开始时间: 2009年1月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •written informed consent; adult patients, aged between 18 and 70 years; Crohn's disease or ulcerative colitis; azathioprine, 6-mercaptopurine or 6-thioguanine therapy, Grade 1 or 2 on the CTCAE v3.0 of at least one of the following liver tests: aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), alkaline phosphatase (AP), gamma-glutamyl transferase (GGT) or total bilirubine (Bili).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Serological findings consistent with active viral hepatitis A, B, C EBV or CMV; findings suggesting auto-immune hepatitis (AIH); cholestasis; known liver diseases inlcuding: Hepatitis A, B or C, cirrhosis, AIH, primary sclerosing cholangitis, primary biliairy cirrhosis, hepatocellular carcinoma, metastatic liver disease or symptomatic cholecystolithiasis; Use of methotrexate or other chemotherapy within the last three months; use of N-acetylcysteine during thioipurine therapy; allergy to N-acetylcysteine; lactation; pregnancy; 6-TGN level >1200 pmol
研究者
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