EUCTR2016-001038-91-NLActive, not recruitingPhase 1
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 sitesStarted: October 25, 2016Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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