Why is this study being done?
This study is being done to measure the following outcomes:
Primary Outcome Measures:
• Determine the safety and tolerability of Recombinant Human Mannose-Binding Lectin (rhMBL) administered i.v. at doses of 0.5 and 1.0 mg/kg, as 8 weekly doses over 8 weeks, in the setting of liver transplantation.

Secondary Outcome Measures:
• Determine the pharmacokinetic (PK) profile of rhMBL
• Determine the pharmacodynamics (PD) (complement deposition) of rhMBL
• Determine the immunogenicity of rhMBL by testing for the presence of anti-rhMBL antibodies
• Detect preliminary evidence of activity of rhMBL by analyzing the incidence of infectious complications.

Who is Eligible to Participate in the Study?
• Patients scheduled to undergo OLT liver transplantation (single organ). Split grafts will not be allowed from OLT donors.
• Donor has an MBL genotype of A/O or O/O.
• Willing to receive transfusions of blood products. 

What is Involved With this Study?
Patients will have received an orthotopic liver transplant (OLT). 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, lymph nodes will be collected from the donor liver at the time of organ harvest for MBL genotyping. 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 (IV) 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.