EUCTR2018-003381-14-SE进行中（未招募）1 期
Budesonide versus Prednisolone as Primary Treatment for AutoimmuneHepatitis: An Open-label, Randomized, Prospective Multicenter 12-monthClinical Trial Evaluating Effect and Side-Effects. - AIHBUDPRED
meå University Hospital0 个研究点目标入组 150 人开始时间: 2019年12月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
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
- •1. A written informed consent is signed before any study-related
- •procedures are performed.
- •2. Male and female subjects aged =18 years of age.
- •3. A definitive diagnosis of autoimmune hepatitis with a score of =6
- •according to the simplified AIH criteria.
- •4. A liver biopsy should, a) have been performed within the last 6
- •months, and, b) show interface inflammation grade of =1 according to
- •the Ludwig-Batts grading scale.
- •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 145
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. Chronic liver disease other than AIH (PBC, PSC, viral hepatitis,
- •hemochromatosis, homozygous alpha-1-antitrypsin deficiency and
- •Wilson disease)
- •2. Ongoing immune-modulating therapy
- •3. Liver cirrhosis/fibrosis grade 4 according to Ludwig-Batts grading
- •scale and/or clinically compensated or decompensated liver cirrhosis
- •(signs of portal hypertension and/or cirrhosis on radiology, ultrasound
- •4. Current malignancy
- •5. Alcohol overconsumption (B-PEth >0.3 µmol/L)
- •6. Contraindication to corticosteroids
- •7. Contraindication to azathioprine
- •8. Suggested non-compliance with the protocol.
- •9. Pregnancy or breast-feeding
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