Untreated Autoimmune hepatitis (AIH) is a progressive disease. Mainstay of treatment are corticosteroids (CS). In addition to being ineffective a substantial minority of cases, corticosteroid side-effects hamper effective therapy in another subgroup. Alternative options for induction of remission are limited. There are reports of successful salvage therapy with Cyclosporine-A (CsA) in steroid refractory cases. In addition, open-labeled studies have shown efficacy of Cyclosporine-A in treatment-naive AIH patients. There are no studies comparing CsA and CS in a head to head trial. The investigators aim to assess the efficacy and tolerability of CsA directly to the CS for induction of remission in treatment-naive AIH patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Cyclosprorine-A will be administered to patients in group-B according to a set protocol and the patients will be followed at regular intervals with appropriate checking of clinical and para-clinical data.
Digestive Disease Research Center, Shariati Hospital
Tehran, Iran
Remission
AST/ALT less than 2x UNL No clinical symptom
Time frame: 12 months
Treatment failure
Failure to achieve AST/ALT less than 2x UNL despite adjusting dose according to protocol
Time frame: 3 months
Frequency of adverse events
Any adverse event (related or unrelated to the study drug) occuring during the induction phase.
Time frame: 12 months
Serious adverse event
Any adverse event requiring hospitalization or leading to disability or death
Time frame: 12 months
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