NL-OMON49891招募中3 期
Tacrolimus versus mycophenolate for AutoImmune hepatitis patients with incompLete response On first line therapy: a Randomized trial - TAILOR
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 86
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
- •Patient is older than 18 years old
- •Probable or definite auto immune hepatitis according to the original or
- •simplified IAIHG criteria (>10 points pre-treatment on the original criteria or
- •>6 points on the simplified criteria)(2, 3)
- •Incomplete responder on at least a half year of first-line treatment, with at
- •least last 6 months azathioprine / 6-MP) / 6-TG and prednisolone or budesonide,
- •and ALT 1.5 - 10x ULN for at least 2 months
- •Patient is capable of understanding the purpose and risks of the study, has
- •been fully informed and has given written informed consent to participate in
排除标准
- •Presence of decompensated liver disease, defined as ascites, coagulopathy
- •(INR >1.5), encephalopathy, variceal bleed, hepatopulmonal syndrome,
- •hepatorenal syndrome or HCC in the past 6 months
- •Signs of other liver diseases as NAFLD, Wilson disease, hemochromatosis,
- •alcoholic liver disease or hepatitis B/C/D
- •Clinical diagnosis of overlap / variant syndrome with PBC or PSC
- •Liver transplantation in the medical history or currently on the waiting list
- •for liver transplantation
- •Incompliance with therapy during the last 12 months
- •Active infections during inclusion including latent tuberculosis and HIV
- •co-infection
- •Allergic or hypersensitive to tacrolimus or MMF
- •An estimated glomerular filtration rate (eGFR) of <60 mL/min
- •Pregnancy or intention to become pregnant in the next 12 months
- •Use of TAC or MMF in the past
- •Malignancy in the medical history in the past five years, with no history or
- •current use of chemotherapy.
研究者
相似试验
Unknown
4 期
Tacrolimus Versus Mycophenolate for Autoimmune Hepatitis Patients With Incomplete Response on First Line TherapyAutoimmune HepatitisNCT05221411Leiden University Medical Center86
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1 期
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不适用
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