sPIF CLINICAL STUDY PROTOCOL IN AUTOIMMUNE HEPATITIS

Inclusion Criteria

• •Female, aged from 18 to 70 years old, of non-child bearing potential (to avoid the possibility if antibodies are formed to sPIF this could put the patient at risk for future fertility)
• •Females must be either
• •* Postmenopausal for greater than two years,
• •* Postmenopausal for less than two years with an follicle stimulating hormone (FSH) level greater \> 40 million international units per milliliter (mIU/mL )
• •* Or documented as surgically sterile (bilateral tubal ligation, bilateral oophorectomy or post-hysterectomy) at least three months prior to the screening evaluation
• •Autoimmune hepatitis as documented by a:
• •* Pretreatment score ≥15
• •* Or a post-treatment score of ≥17 on the International Criteria for the Diagnosis of Autoimmune Hepatitis (Appendix 2)
• •Treatment with prednisone and/or other oral, immunosuppressive drug(s) must have been stabilized for at least 6 weeks prior to screening for this study.
• •Stable ALT levels with a fixed dose of their immunosuppressant medications
• •Subjects do not have to have had a documented relapse after completion of an initial course of therapy
• •Permitted concomitant immunosuppressant medications will include
• •* Azathioprine dose equal to/or less 100 mg per day,
• •* Budesonide dose equal to/or less 9 mg per day,
• •* Mycophenolate mofetil equal to/or less 3000 mg per day,
• •* Prednisone equal to/or less than 10 mg per day
• •* Ursodeoxycholic acid equal to/or less than 1000 mg per day
• •In the judgment of the Investigator, be in reasonable general health, based on review of the results of a screening evaluation (to include physical examination, measurement of vital signs, 12-lead ECG trace and the collection of blood and urine for routine clinical laboratory testing), performed no more than 30 days prior to Day 1 of study.
• •Patients must agree to abstain from alcohol use during their participation in the study protocol.
• •Alanine aminotransferase (ALT) levels of no more than five times the upper limit of normal (reference) range (ULN) at the screening evaluation.
• •Normal renal function as determined by a serum creatinine
• •A female of childbearing potential who is documented as either surgically sterile (bilateral tubal ligation, bilateral oophorectomy or post-hysterectomy at least 3 months prior to the screening evaluation) or post-menopausal for ≥ 2 years.