MedTrace Logo

A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj.

NCT05686759 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2025-06-25

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of undiluted intravenous infusion of I.V.-Hepabig inj. in post-liver transplant patients

Conditions

Interventions

BIOLOGICAL

Undiluted I.V.-Hepabig inj(GC5103)

undiluted I.V.-Hepabig inj(GC5103) 10,000 International Unit

BIOLOGICAL

Diluted I.V.-Hepabig inj(GC5103)

Diluted I.V.-Hepabig inj(GC5103) 10,000 International Unit

Sponsors & Collaborators

  • GC Biopharma Corp

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-13
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT05686759 on ClinicalTrials.gov