Prospective study of immunological factors and genetic expression implicated in operational tolerance in liver transplant patients

FFIS-Región de Murcia0 个研究点目标入组 17 人开始时间: 2017年7月25日最近更新: 2023年9月18日

适应症

试验速览

2018 Results article in https://pubmed.ncbi.nlm.nih.gov/30019408/ (added 06/09/2023)

•1. Older than 18 years
•2. Liver transplantation more than three years ago
•3. Treatment with IS that includes cyclosporine or tacrolimus
•4. Have a normal liver function in the last year (defined as normal transaminases and alkaline phosphatase in all laboratory controls performed during the last year)
•5. Not acute rejection in the last year and not chronic rejection
•6. Normal hepatic biopsy according the Banff Working Group criteria for IS withdrawal
•7. Etiology of the underlying disease: cirrhosis (with or without hepatic tumour) of any cause (except autoimmune etiopathogeny diseases): alcoholic B virus, C virus cirrhosis, cryptogenetic, ..., metabolic diseases, familial amyloid polyneuropathy; biliary atresia, fulminant hepatitis no A, no B, no C
•8. Patients who offer sufficient guarantees of adherence to the protocol; I. Patients who give written informed consent to participate in the study

•1. Transplantation of another non-hepatic organ
•2. Liver transplantation due to a disease of autoimmune etiopathogenesis (primary biliary cholangitis, primary sclerosing cholangitis or autoimmune hepatitis)
•3. Patients with hepatic retransplantation
•4. Active infection with hepatitis C virus or hepatitis B virus
•5. Patients with chronic rejection, or acute rejection in the last year
•6. Inability to understand informed consent; e: liver biopsy with significant portal or lobular inflammation
•7. Patients with rheumatic/autoimmune disease requiring sustained immunosuppressive treatment

发起方

FFIS-Región de Murcia