New York, NYNCT06455280Now EnrollingIRB Ready

Autoimmune Liver Disease Clinical Trial in New York, NY

Access cutting-edge autoimmune liver disease treatment through this phase 1 clinical trial at a research site in New York. Study-provided care at no cost to qualified participants.

Sponsored by Elizabeth C. Verna

Quick Self-Assessment

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Expert Care in New York

Access autoimmune liver disease specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related autoimmune liver disease treatment provided free

Apply for This New York Location

Check if you qualify for this autoimmune liver disease clinical trial in New York, NY

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to New York

    Convenient for NY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit New York site if eligible
  4. 4Begin participation

About This Autoimmune Liver Disease Study in New York

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. The purpose of this pilot, open-label phase 1 study is to determine the safety of siplizumab for induction in patients with AILD undergoing LT. Up to eight (8) subjects will receive siplizumab 0.6 mg/kg/dose on the day of transplant (Day 0) and Day 4 post-transplant, for a total of two doses. All subjects will be followed in the study for 12 months post-LT.

Sponsor: Elizabeth C. Verna

Who Can Participate

Inclusion 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

Exclusion Criteria

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New York?

Yes, this clinical trial (NCT06455280) has an active research site in New York, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Autoimmune Liver Disease Treatment Options in New York, NY

If you're searching for autoimmune liver disease treatment options in New York, NY, this clinical trial (NCT06455280) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New York research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced autoimmune liver disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all autoimmune liver disease clinical trials near you to find additional studies recruiting in your area.

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