The Phase II clinical trial is a open-label, multi-center, prospective, randomized study to evaluate the efficacy, safety and tolerability of LCP-Tacro tablets given once daily versus azathioprine (AZA), each in combination with prednisone, for the treatment of autoimmune hepatitis. Up to 60 patients will be randomized (1:1) to receive treatment with LCP-Tacro + prednisone versus AZA + prednisone.
The clinical trial is expected to enroll up to 60 patients in up to 12 centers throughout the US and Canada. The company expects to report top-line clinical trial results in the first half of 2009.