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A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj. - Trial NCT05686759

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.

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NCT05686759
Phase 3
Recruiting
biological
Trial Details
ClinicalTrials.gov • NCT05686759
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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

Study Focus

Hepatitis B

Undiluted I.V.-Hepabig inj(GC5103)

Interventional

biological

Sponsor & Location

GC Biopharma Corp

Seoul, South Korea

Timeline & Enrollment

Phase 3

Jan 18, 2023

Sep 01, 2025

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 B
Acute hepatitis B without delta-agent and without hepatic coma
Acute delta-(super)infection in chronic hepatitis B
Chronic viral hepatitis B without delta-agent
Chronic viral hepatitis B without delta-agent : other and unspecified phase

Data Source

ClinicalTrials.gov

NCT05686759

Non-Device Trial