Autoimmune Hepatitis Clinical Trial
Official title:
A Phase II, Open-Label, Multi-Center, Prospective, Randomized Study of LCP-Tacro Tablets vs. Azathioprine, in Combination With Corticosteroids, for the Treatment of Autoimmune Hepatitis
An open-label, multi-center, prospective, randomized study to evaluate the efficacy, safety and tolerability of LCP-Tacro tablets given once daily vs. azathioprine, each in combination with prednisone, for the treatment of autoimmune hepatitis (AIH).
An open-label, multi-center, prospective, randomized study to evaluate the efficacy, safety
and tolerability of LCP-Tacro tablets given once daily vs. azathioprine for the treatment of
autoimmune hepatitis (AIH).
Patients with histologically confirmed chronic hepatitis who fulfill criteria established by
the International Autoimmune Hepatitis Group (IAIHG) and Inclusion and Exclusion criteria
will be enrolled after having signed an informed consent document.
Up to 60 patients will be randomized (1:1) to receive treatment with LCP-Tacro + prednisone
vs. azathioprine (AZA) + prednisone.
- LCP-Tacro will be started at 2 mg once daily (q.d.) with weekly measurement of
tacrolimus whole blood trough levels and adjustment of the daily dose of LCP-Tacro to
achieve target tacrolimus levels of 3 - 6 ng/mL. Patients with histological evidence of
cirrhosis and a Model for End-Stage Liver Disease (MELD) score ≤ 8 will commence
LCP-Tacro at a fixed dose of 1 mg once daily, with subsequent dosage adjustments to
maintain tacrolimus trough levels at 3 - 6 ng/mL.
- AZA will be started at 50 - 100 mg (approximately 1 mg/kg) once daily (q.d.).
Patients will also commence treatment with prednisone 30 mg/day for one week, then 20 mg/day
for one week, then 15 mg/day for two weeks, then 10 mg/day through Month 6.
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