A Study of SIPLIZUMAB in AILD and LT Patients

Exclusion Criteria

• •1. Presence or history of significant liver disease other than AIH or PSC, including viral hepatitis, alcohol-related liver disease and biopsy-proven non-alcoholic steatohepatitis
• •2. Prior transplant
• •3. Listed for multiorgan transplant
• •4. Acute liver failure
• •5. Known malignancy, including cholangiocarcinoma and hepatocellular carcinoma
• •6. Other investigational products in the last 30 days or 5 half lives
• •7. Pregnant/lactating or unwilling to use contraception
• •8. Leukopenia (WBC less than 2,000/mm3
• •9. Absolute lymphocyte count \< 200/mm3
• •10. Sero-positive for HIV-1
• •11. Hepatitis C Virus (HCV) antibody or RNA positive (within 6 months of screening)
• •12. HBsAg, hepatitis B virus (HBV) DNA or HBcAb positive (within 6 months of screening)
• •13. Alcohol use exceeding 30g/day for men or 20g/day for women, and/or known phosphatidylethanol (PETH) level \>80 in the 3 months prior to LT
• •14. Untreated latent TB infection as detected by QuantiFERON Gold Plus Interferon Gamma Release Assay (IGRA) (or current standard interferon gamma release assay for TB)
• •15. Receipt of any live-attenuated vaccine within 2 months of transplant.
• •1. Renal failure with dialysis or with estimated glomerular filtration rate (eGFR) \< 30 at the time of LT
• •2. Model for end-stage liver disease (MELD)-Na score \>30
• •3. Donor features of Donation after Cardiac Death (DCD), HCV Ab or nucleic acid testing (NAT+), HBcAb or HBsAg+, or blood types A, B, and O incompatible organ