NCT06060808

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

2.1 years

First QC Date

September 24, 2023

Last Update Submit

September 24, 2023

Conditions

Liver Transplant Rejection

Keywords

gene polymorphism

Outcome Measures

Primary Outcomes (1)

  • gene polymorphism

    gene polymorphism of NFKBIA and PTPN22 genes

    baseline

Secondary Outcomes (1)

  • immunosuppressant levels

    14 days

Interventions

gene polymorphismGENETIC

gene polymorphism of NFKBIA and PTPN22 genes

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with end stage liver disease(ESLD) underwent living donor liver transplantation were recruited from Ain Shams University hospitals, Cairo, Egypt.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients were excluded if they had multi-organ transplantation, had previously received a liver transplant, or were receiving an ABO-incompatible transplant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sara Mohamed Mohamed

Cairo, Egypt

Location

MeSH Terms

Interventions

Polymorphism, Genetic

Intervention Hierarchy (Ancestors)

Genetic VariationGenetic Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

September 24, 2023

First Posted

September 29, 2023

Study Start

March 15, 2021

Primary Completion

April 23, 2023

Study Completion

July 24, 2023

Last Updated

September 29, 2023

Record last verified: 2023-09

Locations

EG(1)