drugset
drugset / Trial / NCT05666453

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

NCT05666453 ↗

Phase 2 Terminated 59 enrolled SK Plasma Co., Ltd.
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2022-04-25
Primary completion
2024-05-07
Completion
2024-07-01

Outcome

Outcome not reported

Stopped: “Change of Clincal Development Plan”

Drugs

EvaluationDrugModalityDoseRoute
Subject LIV-GAMMA SN Inj. Protein / enzyme biologic 0.6 g/kg Intravenous

Indications

No indication recorded.