NCT05666453

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: SK Plasma Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Transplantation

Interventions

Type	Name	Description
BIOLOGICAL	LIV-GAMMA SN Inj.	LIV-GAMMA SN Inj. is administered at a dose of 0.6 g/kg/day from anhepatic phase to Day 2 post-operative to patients undergoing ABO-incompatible liver transplantation as an experimental group.
OTHER	No intervention	None of investigational drugs are administered to patients.

Timeline

• Start date: 2022-04-25
• Primary completion: 2024-05-07
• Completion: 2024-07-01
• First posted: 2022-12-27
• Last updated: 2024-08-30

Locations

5 sites across 1 country: South Korea