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

NCT03519113 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2020-01-30

No results posted yet for this study

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.

Conditions

  • Hepatitis B Infection

Interventions

BIOLOGICAL

GC1102 80,000 IU

recombinant human hepatitis B immunoglobulin

BIOLOGICAL

GC1102 100,000 IU

recombinant human hepatitis B immunoglobulin

BIOLOGICAL

I.V HBIG

human anti-hepatitis B Immunoglobulin

Sponsors & Collaborators

  • Green Cross Corporation

    lead INDUSTRY

Principal Investigators

  • Seung-Gyu Lee, Ph.D · Seoul Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-29
Primary Completion
2022-03-31
Completion
2022-09-30

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 NCT03519113 on ClinicalTrials.gov