A Study of SIPLIZUMAB in AILD and LT Patients

Launched by ELIZABETH C. VERNA · Jun 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called siplizumab to see if it can help patients with autoimmune liver disease (AILD) who are preparing for a liver transplant. AILD includes conditions like autoimmune hepatitis and primary sclerosing cholangitis, which can cause the body’s immune system to attack the liver. The main goal of the trial is to find out if siplizumab is safe for these patients during and after their transplant, particularly in preventing complications that can arise from the immune system attacking the new liver.

To participate in the trial, patients need to be at least 18 years old, have a confirmed diagnosis of autoimmune hepatitis or primary sclerosing cholangitis, and be on the waiting list for a liver transplant. They must also have tested positive for a virus called Epstein-Barr within the last year. In this study, up to eight participants will receive two doses of siplizumab—one on the day of the transplant and another four days later. They will be monitored for 12 months after the transplant to track their health and any effects from the medication. It’s important to know that not everyone will qualify, as certain medical conditions and past treatments may exclude some patients from joining the trial.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Able to provide informed consent
• • 2. Age ≥ 18 years old
• • 3. Clinical diagnosis of AIH and/or PSC
• • 4. Listed for liver transplantation
• • 5. Epstein-Barr virus (EBV) seropositive within 12 months of screening
• 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.
• • ADDITIONAL exclusion criteria to be reviewed at the time 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