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New treatment option for Autoimmune Liver Disease
Official title A Study of SIPLIZUMAB in AILD and LT Patients
ClinicalTrials.gov ID: NCT06455280
What this study is testing
What is Siplizumab?
Siplizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for autoimmune liver disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- There is a significant unmet need for safe and effective therapeutic approaches to prevent immune-mediated graft injury and its complications in liver transplant (LT) recipients with autoimmune liver disease (AILD) including autoimmune hepatitis and primary sclerosing cholangitis. Siplizumab is an anti-cluster of differentiation 2 (CD2) monoclonal antibody that has demonstrated a favorable safety profile of siplizumab in over 779 human subjects and has been shown to target memory T cells-a key driver in the immune processes surrounding rejection and autoimmunity post LT in AILD.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Able to provide informed consent
- Age ≥ 18 years old
- Clinical diagnosis of AIH and/or PSC
- Listed for liver transplantation
- Epstein-Barr virus (EBV) seropositive within 12 months of screening
You likely can't join if
- Presence or history of significant liver disease other than AIH or PSC, including viral hepatitis, alcohol-related liver disease and biopsy-proven...
- Prior transplant
- Listed for multiorgan transplant
- Acute liver failure
- Known malignancy, including cholangiocarcinoma and hepatocellular carcinoma
- Other investigational products in the last 30 days or 5 half lives
See the full eligibility criteria
- Able to provide informed consent
- Age ≥ 18 years old
- Clinical diagnosis of AIH and/or PSC
- Listed for liver transplantation
- Epstein-Barr virus (EBV) seropositive within 12 months of screening
- 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
- Prior transplant
- Listed for multiorgan transplant
- Acute liver failure
- Known malignancy, including cholangiocarcinoma and hepatocellular carcinoma
- Other investigational products in the last 30 days or 5 half lives
- Pregnant/lactating or unwilling to use contraception
- Leukopenia (WBC less than 2,000/mm3
- Absolute lymphocyte count \< 200/mm3
- Sero-positive for HIV-1
- Hepatitis C Virus (HCV) antibody or RNA positive (within 6 months of screening)
- HBsAg, hepatitis B virus (HBV) DNA or HBcAb positive (within 6 months of screening)
- 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
- Untreated latent TB infection as detected by QuantiFERON Gold Plus Interferon Gamma Release Assay (IGRA) (or current standard interferon gamma release assay for TB)
- Receipt of any live-attenuated vaccine within 2 months of transplant. ADDITIONAL exclusion criteria to be reviewed at the time of transplant
- Renal failure with dialysis or with estimated glomerular filtration rate (eGFR) \< 30 at the time of LT
- Model for end-stage liver disease (MELD)-Na score \>30
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.