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

Stopped early · Phase 2

Conditions studied: Autoimmune Hepatitis

In brief

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).

Key facts

Study ID

NCT00608894

Run by

Veloxis Pharmaceuticals

People needed

13

Starts

2007-12-01

Expected to finish

2009-07-01

Last updated by the study team

2020-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women at least 18 years of age with a diagnosis of definite or probable AIH defined by the revised International Autoimmune Hepatitis Group (IAIHG) criteria
• Elevation of serum ALT ≥ 1.5 times the upper limit of normal
• Liver biopsy showing chronic hepatitis consistent with AIH
• Patients able to swallow the study medication
• Patients capable of understanding the purposes and risks of the study, who can give written informed consent and who are willing to participate in and comply with the study
• Women of childbearing potential must have a negative serum pregnancy test within seven days prior to receiving study medication and agree to use contraceptive measures to avoid pregnancy during participation in the trial.

You may not qualify if…

• Patients with other concurrent liver disease
• Patients with cirrhosis on liver biopsy with a MELD score > 15
• Patients with a history or presence of decompensated liver disease
• Patients with serum creatinine ≥ 1.5 mg/dL prior to enrollment
• Patients positive for HCV RNA or Hepatitis B surface antigen (HBsAg)
• Patients with a history of alcohol intake > 25 g/day within the past six months
• Patients with TSH outside normal range accompanied by an abnormal T4
• Patients with alpha-fetoprotein ≥ 20 ng/mL
• Patients with severe anemia (hemoglobin < 8 g/dL), leukopenia (WBC < 4000/mm3), or thrombocytopenia (platelet count < 100,000/mm3)
• Patients with a history of recent exposure to hepatotoxic drugs
• Patients who require therapy with any immunosuppressive agent other than those prescribed in the study
• Patients unable or unwilling to provide informed consent
• Pregnant or nursing women
• Patients with reproductive potential who are unwilling/unable to use a double barrier method of contraception
• Patients who have been treated with another investigational agent in the three months prior to enrollment
• Patients receiving any drug interfering with tacrolimus metabolism
• Patients with current malignancy or a history of malignancy (within the past 5 years), except basal or non-metastatic squamous cell carcinoma of the skin that has been treated successfully
• Patients with uncontrolled concomitant infection, a systemic infection requiring treatment, or any other unstable medical condition that could interfere with the study objectives
• Patients with severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus
• Patients with a known hypersensitivity to azathioprine, corticosteroids or tacrolimus
• Patients with any form of current substance abuse, psychiatric disorder or a condition that, in the opinion of the Investigator, may invalidate communication with the Investigator
• Patients who are recipients of an organ transplant or who require treatment with immunosuppressives or corticosteroids for any disease other than AIH.

Where it is running

• Mayo Clinic - Phoenix — Phoenix, Arizona, United States
• Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Mount Sinai Medical Center — New York, New York, United States
• St. Luke's Advanced Liver Therapies — Houston, Texas, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Heritage Medical Research Clinic — Calgary, Alberta, Canada
• Zeildler Ledcor Centre — Edmonton, Alberta, Canada
• John Buhler Research Centre, University of Manitoba Health Sciences Centre — Winnipeg, Manitoba, Canada
• Queen Elizabeth II Health Sciences Centre — Halifax, Nova Scotia, Canada

Full record on ClinicalTrials.gov

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