A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj.
ConditionHepatitis B
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-64
SponsorGC Biopharma Corp
About this trial
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
Eligibility criteria
Qualifiers
Aged ≥18 and <65 years at the time of signing the consent form
Subjects who had history of liver transplantation due to HBV-related end-stage liver disease such as cirrhosis, liver cancer and fulminant hepatic failure and received treatment for prevent hepatitis B recurrence
HBsAg(+) before liver transplantation
Subjects who have been received I.V.-Hepabig inj more than 3 times dose of 10,000International Unit/4weeks regimen
Disqualifiers
Subject with history of anaphylaxis to any component of the investigational product
Pregnant or breast-feeding women
Deficiency of Immunoglobulin A
Clinically significant renal diseases (serum creatinine >2.0mg/dL, anuria, renal failure or on dialysis at screening)
Trial design
Treatments tested in this trial
- Undiluted I.V.-Hepabig inj(GC5103)
- Diluted I.V.-Hepabig inj(GC5103)
Treatment groups
105 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov