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

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).

Conditions

• Autoimmune Hepatitis

Interventions

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.

DRUG

Azathioprine

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.

Sponsors & Collaborators

• Veloxis Pharmaceuticals

  lead INDUSTRY

Principal Investigators

• Gerald Y Minuk, M.D. · University of Manitoba Health Sciences Centre, Winnipeg

• Andrew Mason, MD · University of Alberta, Edmonton

• Russell H Wiesner, MD · Mayo Clinic, Rochester, MN

• John M Vierling, MD · Baylor College of Medicine

• Velimir A Luketic, MD · Virginia Commonwealth University, Richmond, VA

• Joseph A Odin, MD, PhD · Mount Sinai Medical Center, New York, NY

• Elizabeth Carey, MD · Mayo Clinic

• John R Lake, MD · University of Minnesota

• Barry G Rosser, MD · Mayo Clinic

• Steven L Flamm, MD · Northwestern University

• Kevork M Peltekian, MD · Queen Elizabeth II Health Sciences Centre

• Mark G Swain, MD · University of Calgary

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-12-31

Primary Completion

2009-04-30

Completion

2009-07-31

Countries

• United States
• Canada

Study Locations