NL-OMON52983
Completed
Phase 4
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
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Autoimmune hepatitis
- Sponsor
- eids Universitair Medisch Centrum
- Enrollment
- 66
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
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
- •3\. Age \>\= 18 years
- •4\. Must provide informed consent and agree to comply with the trial protocol
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
- •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
Outcomes
Primary Outcomes
Not specified
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