NL-OMON33536已完成2 期
Effect of N-acetylcysteine on thiopurine related hepatotoxicity in IBD patients - NACTOX
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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).
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
相似试验
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Effect of N-acetylcysteine on thiopurine related hepatotoxicity in IBD patients - NACTOXadult patients (18-70 years old) who have been treated with azathioprine, 6-mercaptopure or 6-thioguanine for inflammatory bowel disease, in whom hepatotoxicity occured as an adverse event, are eligible. Prior to definite inclusion, the patients will be screened to make other causes of hepatotoxicity less likely.EUCTR2008-005015-17-NLVU university medical centre
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