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

• Status: Terminated
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Veloxis Pharmaceuticals
• Treatments: Azathioprine; Prednisone; Tacrolimus

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.