LCP-Tacro vs. Azathioprine 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).
Drug: LCP-Tacro (tacrolimus)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- 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 ] [ Designated as safety issue: No ]
- Percent of patients who achieve biochemical remission by Month 3 during treatment with LCP-Tacro + prednisone or azathioprine + prednisone. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||December 2007|
|Study Completion Date:||July 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
LCP-Tacro tablets(1,2,and 5mg tacrolimus)+ prednisone tablets(5mg)
Drug: LCP-Tacro (tacrolimus)
LCP-Tacro(tacrolimus)tablets starting at 2 mg once daily, then adjusted to achieve and maintain target whole blood tacrolimus levels of 3 - 6 ng/mL, plus 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.
Other Name: 1,2,and 5mg tacrolimus tablets
Active Comparator: Azathioprine
Azathioprine tablets(50mg)+ prednisone tablets(5mg)
Azathioprine tablets 50 - 100 mg (approximately 1 mg/kg) once daily, plus 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.
Other Name: 50mg azathioprine tablets + 5mg prednisone tablets
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.
|United States, Arizona|
|Mayo Clinic - Phoenix|
|Phoenix, Arizona, United States, 85054|
|United States, Florida|
|Mayo Clinic - Jacksonville|
|Jacksonville, Florida, United States, 32216|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Rochester, Minnesota, United States, 55905|
|United States, New York|
|Mount Sinai Medical Center|
|New York, New York, United States, 10029|
|United States, Texas|
|St. Luke's Advanced Liver Therapies|
|Houston, Texas, United States, 77030|
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Heritage Medical Research Clinic|
|Calgary, Alberta, Canada, T2N 4N1|
|Zeildler Ledcor Centre|
|Edmonton, Alberta, Canada, T6G 2X8|
|John Buhler Research Centre, University of Manitoba Health Sciences Centre|
|Winnipeg, Manitoba, Canada, R3E 3P4|
|Canada, Nova Scotia|
|Queen Elizabeth II Health Sciences Centre|
|Halifax, Nova Scotia, Canada, B3H 2Y9|
|Principal Investigator:||Gerald Y Minuk, M.D.||University of Manitoba Health Sciences Centre, Winnipeg|
|Principal Investigator:||Andrew Mason, MD||University of Alberta, Edmonton|
|Principal Investigator:||Russell H Wiesner, MD||Mayo Clinic - Rochester, MN|
|Principal Investigator:||John M Vierling, MD||Baylor College of Medicine|
|Principal Investigator:||Velimir A Luketic, MD||Virginia Commonwealth University, Richmond, VA|
|Principal Investigator:||Joseph A Odin, MD, PhD||Mount Sinai Medical Center, New York, NY|
|Principal Investigator:||Elizabeth Carey, MD||Mayo Clinic - Phoenix|
|Principal Investigator:||John R Lake, MD||University of Minnesota - Clinical and Translational Science Institute|
|Principal Investigator:||Barry G Rosser, MD||Mayo Clinic|
|Principal Investigator:||Steven L Flamm, MD||Northwestern University|
|Principal Investigator:||Kevork M Peltekian, MD||Queen Elizabeth II Health Sciences Centre|
|Principal Investigator:||Mark G Swain, MD||University of Calgary|