Liver Transplantation Clinical Trial
Official title:
A Multicenter, Open-Label, Randomized, Phase 1B Study Evaluating the Safety and Tolerability of Intravenous Recombinant Human Mannose‑Binding Lectin (rhMBL) in Liver Transplant Recipients
This is a multicenter, open-label, randomized, Phase 1B study evaluating liver transplant recipients receiving rhMBL (2 cohorts) or without rhMBL (1 cohort).
This is a multicenter, open-label, randomized, Phase 1B study evaluating liver transplant
recipients receiving rhMBL (2 cohorts) or without rhMBL (1 cohort).
Patients will have received an orthotopic liver transplant (OLT) or a living related donor
(LRD) liver transplant. Patients in all cohorts are to receive immunosuppressant therapy and
anti-infectious prophylactic supportive therapy according to institutional standards.
The donor's mannose-binding lectin (MBL) genotype will be evaluated to determine the liver
transplant recipient's study eligibility. For recipients receiving an OLT, a sample of liver
tissue or lymph nodes will be collected from the donor liver at the time of organ harvest
for MBL genotyping. For recipients receiving a LRD transplant, the MBL genotype of the LRD
will be determined in a companion protocol, "Screening Protocol to Evaluate Mannose-Binding
Lectin (MBL) Genotype in Living Related Donors for Liver Transplant Recipients." A recipient
whose donor has an A/O or O/O MBL genotype will be eligible to participate in this study.
Patients will be randomized in a 2:2:1 ratio to receive up to 8 intravenous (i.v.) infusions
of rhMBL at a dose of 0.5 or 1.0 mg/kg, or to receive no rhMBL, respectively. Approximately
20 patients will be treated in each of the 2 rhMBL arms, and approximately 10 patients will
be treated with standard immunosuppressive agents and anti-infectious prophylaxis but not
with rhMBL.
Cohort 1
- Number of Patients 20
- rhMBL (mg/kg) 0.5
Cohort 2
- Number of Patients 20
- rhMBL (mg/kg) 1.0
Cohort 3
- Number of Patients 10
- rhMBL (mg/kg) None
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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