Clinical Trial: LCP-Tacro vs. Azathioprine for the Treatment of Autoimmune Hepatitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 He

Brief Summary: 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).

Detailed Summary:

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.


Sponsor: Veloxis Pharmaceuticals

Current Primary Outcome: Percent of patients that achieve biochemical remission of (AIH) at Month 6 during treatment with LCP-Tacro + prednisone or azathioprine + prednisone. Biochemical remission is defined as ALT, total bilirubin and gamma globulin within normal limits. [ Time Frame: 6 months ]

Original Primary Outcome: Percent of patients that achieve biochemical remission of (AIH) at Month 6 during treatment with LCP-Tacro + prednisone or azathioprine + prednisone. Biochemical remission is defined as AST, ALT, total bilirubin and gamma globulin within normal limits. [ Time Frame: 6 months ]

Current Secondary Outcome:

  • Percent of patients who achieve biochemical remission by Month 3 during treatment with LCP-Tacro + prednisone or azathioprine + prednisone. [ Time Frame: 3 months ]
  • Percents of patients in each treatment group classified as either in remission, having an incomplete response, a treatment failure, or a case of relapse. Each patient will be classified as being one of the four states at Month 6. [ Time Frame: 6 months ]


Original Secondary Outcome: Same as current

Information By: Veloxis Pharmaceuticals

Dates:
Date Received: January 23, 2008
Date Started: December 2007
Date Completion:
Last Updated: December 18, 2014
Last Verified: October 2009