Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00415311
Status:
TERMINATED
Last Update Posted:
2011-08-09
First Post:
2006-12-20
Brief Title:
A Multicenter Study Evaluating the Safety and Tolerability of Intravenous rhMBL in Liver Transplant Recipients
Sponsor:
Enzon Pharmaceuticals Inc
Organization:
Enzon Pharmaceuticals Inc
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision to terminate the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 donors mannose-binding lectin MBL genotype will be evaluated to determine the liver transplant recipients 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 AO or OO MBL genotype will be eligible to participate in this study
Patients will be randomized in a 221 ratio to receive up to 8 intravenous iv infusions of rhMBL at a dose of 05 or 10 mgkg 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 mgkg 05
Cohort 2
Number of Patients 20
rhMBL mgkg 10
Cohort 3
Number of Patients 10
rhMBL mgkg None
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 donors mannose-binding lectin MBL genotype will be evaluated to determine the liver transplant recipients 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 AO or OO MBL genotype will be eligible to participate in this study
Patients will be randomized in a 221 ratio to receive up to 8 intravenous iv infusions of rhMBL at a dose of 05 or 10 mgkg 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 mgkg 05
Cohort 2
Number of Patients 20
rhMBL mgkg 10
Cohort 3
Number of Patients 10
rhMBL mgkg None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None