A Study of SIPLIZUMAB in AILD and LT Patients
Recruiting
Phase 1
Interventional Study
Autoimmune Liver Disease
Liver Transplant Disorder
Autoimmune Hepatitis
Primary Sclerosing Cholangitis
End Stage Liver DIsease
Cirrhosis, Liver
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 8 (estimated)
- Sponsor
- Elizabeth C. Verna · Other
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About This Trial
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 …
Trial Locations
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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 …
Contacts