NL-OMON52983已完成4 期
A randomised, open-label clinical trial assessing the efficacy and safety of mycophenolate mofetil versus azathioprine for induction of remission in treatment naive autoimmune hepatitis - CAMARO
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 66
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Probable or definite diagnosis of autoimmune hepatitis according to the
- •International Autoimmune Hepatitis Study Group criteria (table 2) 9:
- •Definite autoimmune hepatitis: >= 7
- •Probable autoimmune hepatitis >= 6
- •2. First presentation of AIH requiring treatment according to the current EASL
- •3. Age >= 18 years
- •4. Must provide informed consent and agree to comply with the trial protocol
排除标准
- •1. Overlap syndrome with PSC or PBC (Paris criteria 29, strong positive AMA,
- •past liver biopsy or cholangiographic findings compatible with PBC or PSC).2.
- •Presence of clinical significant hepatic decompensation including:• History of
- •liver transplantation, current active placement on a liver transplant waiting
- •Portal hypertension with complications including: poorly controlled or
- •diuretic resistant ascites, history of variceal bleeding or related therapeutic
- •interventions (e.g. variceal banding, transjugular intrahepatic portosystemic
- •shunts) or hepatic encephalopathy.
- •Cirrhosis with complications, including history or presence of: spontaneous
- •bacterial peritonitis, hepatocellular carcinoma, hepatorenal syndrome
- •a. N.B. cirrhosis without complications as mentioned above, is not an exclusion
- •3. Current treatment with predniso(lo)ne and/or immunosuppressive medication
- •for an indication other than autoimmune hepatitis4. Current systemic
- •infection5. Other clinically significant medical conditions that could
- •interfere with the trial6. If female of childbearing potential: known
- •pregnancy, or unwilling to practice anticontraceptive measures. 7. History of
- •noncompliance with medical regimens, or patients who are considered to be
- •potentially unreliable or unable to participate8. Mental instability or
- •incompetence, such that the validity of informed consent or compliance with the
- •trial is uncertain
研究者
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