Clinical Trials Logo
  1. Home
  2. Liver Transplantation
  3. NCT01198314

Withdrawal of Immunosuppression in Long Term Stable Liver Transplant Recipients — tolerance  

Liver Transplantation Clinical Trial

Official title:
Gradual Withdrawal of Immunosuppression in Long Term Stable Liver Transplant Recipients Using Immunologic Profile Predicting Operational Tolerance

Clinical Trial Summary

Long-term immunosuppression carries potential adverse effects such as risk of infection, malignancy, renal insufficiency, diabetes and hypertension. In clinical liver transplantation, some liver transplant recipients maintain allograft function without immunosuppressive drugs. This is called as "operational tolerance". Many attempts have been made to identify immunological biomarkers predicting operational tolerant patients. Therefore, the investigators aimed to identify patients who have the potential to be operationally tolerant using biomarkers, withdraw immunosuppressant gradually and stop ultimately with monitoring of biomarkers.

Clinical Trial Description

Among long term stable liver transplant recipients, we will select some proportion of patients who have the high potential for obtaining operational tolerance using biomarkers.

Then, we will gradually reduce immunosuppressants and monitor biomarkers as well as biochemical tests. The course of tapering off immunosuppressant will take about 1 year.

During withdrawal of immunosuppression, participants will be closely monitored for liver enzyme, immunological profile.

If there are some signs of rejection, liver biopsy will be undertaken and participants will be treated using immunosuppressant.

After complete withdrawal of immunosuppressant, participants will be followed for at least of 1 year. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01198314
Study type Interventional
Source The Catholic University of Korea
Contact Jong Young Choi, Professor
Phone 82-2-2258-2073
Email jychoi@catholic.ac.kr
Status Recruiting
Phase Phase 2
Start date July 2010
Completion date March 2013
View Details
See also
  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 NCT01425385 - Autoregulation Assessment During Liver Transplantation N/A
Terminated NCT01445236 - Pilot Study of Immunosuppression Drug Weaning in Liver Recipients Exhibiting Biomarkers of High Likelihood of Tolerance N/A
Completed NCT01655563 - Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation Phase 2
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
Terminated NCT00585858 - Cytokine Kinetics Test to Assess the Presence or Absence of Tolerance in Organ Transplant N/A
Withdrawn NCT00585429 - Evaluation of Kidney Disease in Liver Transplant Recipients 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