NCT02304315

A Phase 2 Study of GC1102 (Recombinant Hepatitis B Immunoglobulin) in HBV-related Liver Transplant Recipients

A Randomized, Open-label, Single-center, Phase II Trial to Explore the Safety and Efficacy of GC1102 and Determine Its Optimal Dose After Intravenous Administration in HBV-related Liver Transplant Recipients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Green Cross Corporation · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a proof-of-concept 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.

Detailed 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. Forty volunteers will participate in the study, receive 24-week treatment with low dose (50,000IU) of GC1102 or with high dose (80,000IU) and be followed up till 28 weeks.

Conditions

• Hepatitis B Infection

Interventions

Type	Name	Description
BIOLOGICAL	GC1102 50,000 IU	a recombinant hepatitis B immunoglobulin
BIOLOGICAL	GC1102 80,000 IU	a recombinant hepatitis B immunoglobulin

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2014-12-01
• Last updated: 2016-06-30

Locations

1 site across 1 country: South Korea