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

NCT02304315 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-06-30

No results posted yet for this study

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.

Conditions

  • Hepatitis B Infection

Interventions

BIOLOGICAL

GC1102 50,000 IU

a recombinant hepatitis B immunoglobulin

BIOLOGICAL

GC1102 80,000 IU

a recombinant hepatitis B immunoglobulin

Sponsors & Collaborators

  • Green Cross Corporation

    lead INDUSTRY

Principal Investigators

  • Sung-Gyu Lee, M.D. · Seoul Asan Medical Center

  • Chang-Hee Lee, M.D. · GC Biopharma Corp

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02304315 on ClinicalTrials.gov