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A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in ABO-Incompatible Liver Transplantation

Liver Transplantation Clinical Trial

Official title:
A Multi-center, Prospective, Randomized, Controlled, Open-label, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of IVIg to Prevent Biliary Complications After ABO-Incompatible Living Donor Liver Transplantation

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of LIV-GAMMA SN Inj. administered for consecutive 3 days in adult subjects to prevent biliary complications after ABO incompatible adult to adult living donor liver transplantation (LDLT). The primary objective of this study is to determine the incidence rate of biliary complications for 48 weeks after liver transplantation. Incidence rate of transplant rejection, DSA, antibody reaction, CMV infection, infectious complications, DIHBS and recurrence rate of HCC as well as adverse events are assessed as additional efficacy and safety endpoints in this study.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05666453
Study type Interventional
Source SK Plasma Co., Ltd.
Contact Byung Nam Chung
Phone 82-2-2008-2567
Email byung-nam.chung@sk.com
Status Recruiting
Phase Phase 2
Start date April 25, 2022
Completion date April 30, 2025
View Details
See also
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