Status:
TERMINATED
LCP-Tacro vs. Azathioprine for the Treatment of Autoimmune Hepatitis
Lead Sponsor:
Veloxis Pharmaceuticals
Conditions:
Autoimmune Hepatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Detailed Description
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 hepa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00608894
Start Date
December 1 2007
End Date
July 1 2009
Last Update
March 17 2020
Active Locations (12)
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1
Mayo Clinic - Phoenix
Phoenix, Arizona, United States, 85054
2
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32216
3
Northwestern University
Chicago, Illinois, United States, 60611
4
University of Minnesota
Minneapolis, Minnesota, United States, 55455