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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06060808
Other study ID # gene polymorphism
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 15, 2021
Est. completion date July 24, 2023

Study information

Verified date September 2023
Source Helwan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Our study aimed at studying the impact of gene polymorphism of NFKBIA and PTPN22 genes on rejection episodes in liver transplant Egyptian recipients. Also assess patients' factors associated with graft rejection.


Description:

Liver transplantation is considered an effective therapy for severe liver disease, but graft dysfunction occurs in up to 13% of patients during the first year following transplantation, and rises to 35% after 5 years (Keeffe, 1999; Yu et al., 2001). Graft rejection is one of the major immunological complications following liver transplantation (Zheng et al., 2006). The nuclear factor of kappa light polypeptide gene enhancer B-cells inhibitor-alpha (NFKBIA) gene encodes a member of the nuclear factor-kappa-B inhibitor family. Polymorphisms in this gene might be associated with a susceptibility to acute rejection episodes following liver transplantation, as they may cause an increased activation level of the proinflammatory transcription factor nuclear factor of kappa light polypeptide gene enhancer in B-cells (NFκB). NFκB translocates to the nucleus and promotes the expression of a panel of genes (Karin and Ben-Neriah, 2000). Some of these, for example interleukin-2, interleukin-6, interleukin-12 or tumor necrosis factor-alpha, play an important role in the pathogenesis of allograft rejection and the activation of the immune system in general (Wei and Zheng, 2003). The protein tyrosine phosphatase nonreceptor 22 gene (PTPN22) encodes a strong T-cell regulator called lymphoid protein tyrosine phosphatase. Previously, PTPN22 was described as a susceptibility gene for autoimmunity because it contains single nucleotide polymorphisms (SNPs) associated with several autoimmune diseases. One SNP (rs2476601;1858G>A) has emerged as a particularly potent risk factor for autoimmunity. We address the question whether PTPN22 polymorphismsare also associated with acute rejection after liver transplantation. (Dullin et al., 2015).


Recruitment information / eligibility

Status Completed
Enrollment 105
Est. completion date July 24, 2023
Est. primary completion date April 23, 2023
Accepts healthy volunteers
Gender All
Age group 20 Years to 64 Years
Eligibility Inclusion Criteria: - Adult Patients with ESLD were subjected to living donor liver transplantation due to different etiologies including hepatitis C virus (HCV), hepatitis B virus (HBV), autoimmune hepatitis (AIH), portal venous thrombosis (PVT), cryptogenic hepatitis, Primary sclerosing cholangitis(PSC), hepatocellular and carcinoma(HCC) were eligible for the study. Recipients received calcineurin inhibitors either tacrolimus or cyclosporine as primary immunosuppressant ± MMF or evorilumus ± MMF immediately after transplantation. Exclusion Criteria: - Patients were excluded if they had multi-organ transplantation, had previously received a liver transplant, or were receiving an ABO-incompatible transplant.

Study Design


Related Conditions & MeSH terms


Intervention

Genetic:
gene polymorphism
gene polymorphism of NFKBIA and PTPN22 genes

Locations

Country Name City State
Egypt Sara Mohamed Mohamed Cairo

Sponsors (1)

Lead Sponsor Collaborator
Helwan University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary gene polymorphism gene polymorphism of NFKBIA and PTPN22 genes baseline
Secondary immunosuppressant levels tacrolimus,cycosporin,evrolimus trough levels 14 days
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