Clinical Trial: Cyclosporine-A Versus Prednisolone for Induction of Remission in Auto-immune Hepatitis
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Comparing Efficacy and Tolerability of Cyclosporine-A vs. Prednisolone for Induction of Remission in Auto-immune Hepatitis
Brief Summary: 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.
Detailed Summary:
Sponsor: Tehran University of Medical Sciences
Current Primary Outcome:
- Remission [ Time Frame: 12 months ]AST/ALT less than 2x UNL No clinical symptom
- Treatment failure [ Time Frame: 3 months ]Failure to achieve AST/ALT less than 2x UNL despite adjusting dose according to protocol
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Frequency of adverse events [ Time Frame: 12 months ]Any adverse event (related or unrelated to the study drug) occuring during the induction phase.
- Serious adverse event [ Time Frame: 12 months ]Any adverse event requiring hospitalization or leading to disability or death
Original Secondary Outcome: Same as current
Information By: Tehran University of Medical Sciences
Dates:
Date Received: July 24, 2010
Date Started: December 2005
Date Completion: December 2014
Last Updated: July 26, 2010
Last Verified: July 2010
