HBV-associated Liver Transplant(LT) Patients by IV Injecting GC1102

Status Active, not recruiting

Clinical Trial Summary

This is a clinical study for GC1102 to demonstrate preventing the recurrence of hepatitis B virus (HBV) infection following liver transplantation and a dose-finding study to determine its optional dose.

Clinical Trial Description

GC1102 is a new recombinant hepatitis B immunoglobulin (HBIG) from Chinese Hamster Ovary (CHO) cells. It is a monoclonal antibody and has high affinity and avidity to hepatitis B surface antigen and several advantages compared to HBIG derived from blood plasma of human donors. Volunteers will participate in the study, receive 24-week treatment with 80,000/100,000 IU of GC1102 or I.V HBIG and be followed up till 28 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03519113
Study type	Interventional
Source	Green Cross Corporation
Contact
Status	Active, not recruiting
Phase	Phase 2/Phase 3
Start date	March 29, 2018
Completion date	September 30, 2022

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