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Tests treatment safety and results for Hepatitis B
Official title A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj.
ClinicalTrials.gov ID: NCT05686759
What this study is testing
What is Undiluted I.V.-Hepabig inj(GC5103)?
Undiluted I.V.-Hepabig inj(GC5103) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatitis b.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- Aged ≥18 and \<65 years at the time of signing the consent form
- people who had history of liver transplantation due to HBV-related end-stage liver disease such as cirrhosis, liver cancer and fulminant hepatic...
- HBsAg(+) before liver transplantation
- people who have been received I.V.-Hepabig inj more than 3 times dose of 10,000International Unit/4weeks regimen
You likely can't join if
- 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)
- Hemophilia
- Co-infection with Hepatitis A Virus, Hepatitis C Virus, or Human Immunodeficiency Virus
See the full eligibility criteria
- Aged ≥18 and \<65 years at the time of signing the consent form
- people 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
- people who have been received I.V.-Hepabig inj more than 3 times dose of 10,000International Unit/4weeks regimen
- 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)
- Hemophilia
- Co-infection with Hepatitis A Virus, Hepatitis C Virus, or Human Immunodeficiency Virus
- Subject with history of malignancy within the last 5 years (excluding primary liver cancer)
- Subject received estrogen or hormone replacement therapy within 3 months before screening
- HBsAg or HBeAg or HBV DNA positive at screening
- Anti HBs titer less than below criteria at screening \ 500 IU/L for subject whose HBeAg or HBV DNA were positive(+) before liver transplantation
- Subject with history of drug abuse
- Participated in another clinical study within 30 days (relative to the last dose of investigational product) before screening
- Subject who are determined disqualified to join clinical trials by investigator
The study team makes the final eligibility decision.
Where it's taking place
- Goyang-si, Gyeonggi-do, South Korea
- Suwon, Gyeonggi-do, South Korea
- Seoul, Seoul, South Korea
- Busan, South Korea
- Daejeon, South Korea
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Goyang-si, Gyeonggi-do, South Korea; Suwon, Gyeonggi-do, South Korea; Seoul, Seoul, South Korea; Busan, South Korea; Daejeon, South Korea; Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.