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
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04180735 -
Intestinal Perforation in Patients Receiving an Orthtopic Liver Transplantation in the Montpellier University Hospital
|
||
| Completed |
NCT01011205 -
Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation
|
Phase 3 | |
| Completed |
NCT01888432 -
Efficacy and Safety of Everolimus in Liver Transplant Recipients of Living Donor Liver Transplants
|
Phase 3 | |
| Recruiting |
NCT04203004 -
HOPE With Cytokine Filtration in Liver Transplantation (Cyto-HOPE)
|
N/A | |
| Recruiting |
NCT04564313 -
Safety and Efficacy of Camrelizumab (Anti-PD-1 Antibody) in Recurrent HCC After Liver Transplantation
|
Phase 1 | |
| Not yet recruiting |
NCT02544906 -
Propofol Versus Dexmedetomidine for Prevention of Sevoflurane Agitation in Recipients of Living Donor Liver Transplantation
|
N/A | |
| Withdrawn |
NCT03596970 -
Study of the Effect of Everolimus Immunosuppressive Combination Therapies on Renal Function When Used as a Maintenance Treatment for Liver Transplant Patients.
|
Phase 3 | |
| Completed |
NCT03133065 -
Early Treatment of Recurrent HCV- Infection Post Liver Transplantation in the Era of DAAs
|
Phase 4 | |
| Recruiting |
NCT01705015 -
Organ Transplantation Rehabilitation: Effect of Bedside Exercise Device and Activity Reinforcement
|
N/A | |
| Completed |
NCT01655563 -
Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation
|
Phase 2 | |
| Terminated |
NCT01445236 -
Pilot Study of Immunosuppression Drug Weaning in Liver Recipients Exhibiting Biomarkers of High Likelihood of Tolerance
|
N/A | |
| Completed |
NCT01425385 -
Autoregulation Assessment During Liver Transplantation
|
N/A | |
| Completed |
NCT00938860 -
Sustained Virological Response (SVR) to Antiviral Treatment of Liver Transplant Recipients With Recurrent Hepatitis C
|
Phase 4 | |
| Completed |
NCT00531921 -
Effects of Donor and Recipient Genetic Expression on Heart, Lung, Liver, or Kidney Transplant Survival
|
N/A | |
| Completed |
NCT00456235 -
Reduction in the Risk of Rejection by Mycophenolate Mofetil Dose Adjustment in Liver Transplant Patients With Side Effects Caused by the Calcineurine Inhibitors
|
Phase 4 | |
| Withdrawn |
NCT00585429 -
Evaluation of Kidney Disease in Liver Transplant Recipients
|
N/A | |
| Terminated |
NCT00585858 -
Cytokine Kinetics Test to Assess the Presence or Absence of Tolerance in Organ Transplant
|
N/A | |
| Recruiting |
NCT00147459 -
Immunogenicity of Booster Hepatitis B Vaccines in Children After Liver Transplantation
|
N/A | |
| Withdrawn |
NCT00167492 -
Enteric Coated Myfortic for Liver Transplant Recipients
|
Phase 4 | |
| Terminated |
NCT00161356 -
Ambisome in Liver Transplant Patients
|
Phase 4 |