NCT05686759

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

A Phase 3b Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj. in Post-liver Transplant Patients
GC Biopharma Corp·Phase 3·ClinicalTrials.gov·biologicalRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Hepatitis B
Drug/Device/Intervention
Undiluted I.V.-Hepabig inj(GC5103)
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
GC Biopharma Corp
Location
Seoul, South Korea
Timeline & enrollment
Phase
Phase 3
Start date
Jan 18, 2023
End date
Sep 01, 2025
Enrollment
200 participants
Primary outcome

Adverse events occurred during clinical trials

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

ICD-10 classifications
Acute hepatitis BAcute hepatitis B without delta-agent and without hepatic comaAcute delta-(super)infection in chronic hepatitis BChronic viral hepatitis B without delta-agentChronic viral hepatitis B without delta-agent : other and unspecified phase
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05686759
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05686759 through Pure Global AI's free database. This Phase 3 trial is sponsored by GC Biopharma Corp and is currently Recruiting. The study focuses on Hepatitis B. Target enrollment is 200 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.