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

eiden university medical centre0 个研究点目标入组 70 人开始时间: 2017年6月30日最近更新: 2018年3月12日

适应症

试验速览

暂无简介。

•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 guidelines
•3.Age = 18 years
•4.Must provide informed consent and agree to comply with the trial protocol
•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 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 16

•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 list.
•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 criterion
•3.Current treatment with predniso(lo)ne and/or immunosuppressive medication for an indication other than autoimmune hepatitis
•4.Current systemic infection
•5.Other clinically significant medical conditions that could interfere with the trial
•6.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 participate
•8.Mental instability or incompetence, such that the validity of informed consent or compliance with the trial is uncertain

发起方

eiden university medical centre