Status:
TERMINATED
A Multicenter Study Evaluating the Safety and Tolerability of Intravenous rhMBL in Liver Transplant Recipients.
Lead Sponsor:
Enzon Pharmaceuticals, Inc.
Conditions:
Liver Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a multicenter, open-label, randomized, Phase 1B study evaluating liver transplant recipients receiving rhMBL (2 cohorts) or without rhMBL (1 cohort).
Detailed Description
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...
Eligibility Criteria
Inclusion
- Major Patients must meet all of the following criteria to be eligible for enrollment into the study:
- Capable of understanding the protocol requirements and risks and providing written informed consent.
- Scheduled to undergo OLT or LRD liver transplantation (single organ). Split grafts will not be allowed from OLT donors.
- Donor has an MBL genotype of A/O or O/O.
- Age ≥18 years old.
- Willing to receive transfusions of blood products.
- Any patient who has given informed consent to participate in the clinical study and who meets all entry criteria for the study may participate in the genetic part of the study.
Exclusion
- Patients meeting any of the following exclusion criteria will not be eligible for enrollment.
- Concurrent serious medical illness, in the judgment of the principal investigator (PI), which could potentially interfere with protocol compliance.
- Positive screening pregnancy test or is breast-feeding.
- Female or male patient of reproductive capacity unwilling to use methods appropriate to prevent pregnancy during this study.
- Any condition that, in the opinion of the PI or Enzon makes the patient unsuitable for the study.
- Current participation in another clinical study with an investigational agent and/or use of an investigational drug (not including investigational use of an approved drug) in the 30 days before the first dose of rhMBL.
- Prior liver transplants.
- Systemic chemotherapy within 1 year before liver transplantation.
- Serum creatinine \>5 mg/dL.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00415311
Start Date
December 1 2006
End Date
December 1 2009
Last Update
August 9 2011
Active Locations (4)
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1
University of California San Francisco
San Francisco, California, United States, 94143
2
Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7400
3
Mount Sinai School of Medicine
New York, New York, United States, 10029
4
Vanderbilt University
Nashville, Tennessee, United States, 372321