Phase 3 Hepatitis B Trial, Recruiting NCT05686759 Sponsor: GC Biopharma Corp Condition: Hepatitis B
Back to Hepatitis B

Phase 3 Hepatitis B Trial, Recruiting

NCT05686759
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 to 64 years old at the time of signing the consent form
  • People who have had a liver transplant because of serious liver disease caused by hepatitis B, such as severe scarring of the liver (cirrhosis), liver cancer, or sudden liver failure, and who have been receiving treatment to stop hepatitis B from coming back after the transplant
  • People who tested positive for a hepatitis B surface protein (called HBsAg) before their liver transplant
  • People who have already received a specific hepatitis B antibody injection called IV-Hepabig (10,000 IU every 4 weeks) more than 3 times

Who may not be able to join:

  • People who have had a severe allergic reaction to any ingredient in the study medication
  • People who are pregnant or breastfeeding
  • People who have a condition where their body cannot produce a type of immune protein called Immunoglobulin A
  • People with significant kidney problems, including very high creatinine levels in the blood, no urine output, kidney failure, or those currently on dialysis
  • People who have haemophilia (a condition where blood does not clot properly)
  • People who also have hepatitis A, hepatitis C, or HIV infection
  • People who have had a cancer diagnosis in the last 5 years (liver cancer that was the reason for the transplant is not counted here)
  • People who have taken oestrogen or hormone replacement therapy in the 3 months before the screening visit
  • People who test positive for certain hepatitis B markers (HBsAg, HBeAg, or HBV DNA) at the screening visit
  • People whose hepatitis B antibody levels (Anti-HBs) in the blood do not meet the required levels at screening — the required level depends on what hepatitis B markers were present before the transplant (confirm with trial site)
  • People with a history of drug abuse
  • People who have taken part in another clinical trial within the 30 days before screening
  • People who the trial doctor determines are not suitable to participate for any other reason

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 82-(0)31-260-9570

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
GC Biopharma Corp
Registry
ClinicalTrials.gov
Start date
13 April 2023
Est. completion
30 June 2026

Where this trial is recruiting

🇰🇷 South Korea

Primary endpoints

Adverse events occurred during clinical trials

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov