Phase 4 Hepatitis B Trial, Recruiting NCT05182463 Sponsor: Third Affiliated Hospital, Sun Yat-Sen University Condition: Hepatitis B
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Phase 4 Hepatitis B Trial, Recruiting

NCT05182463
Recruiting Phase 4

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 60 years old, any gender
  • People who have tested positive for the hepatitis B surface antigen (a marker of hepatitis B infection) for more than 6 months
  • People whose hepatitis B blood test results show a specific pattern: negative for HBeAg and positive for anti-HBe (confirm with trial site if unsure what these mean)
  • People with a very low level of hepatitis B virus in their blood (below 2000 IU/mL)
  • People whose liver enzyme levels (ALT and/or AST) are within the normal range
  • People who have never previously been treated with antiviral medications for hepatitis B, including tablets or injections
  • People who are willing to follow the trial requirements and have signed a consent form agreeing to take part

Who may not be able to join:

  • People who are allergic to pegylated interferon α-2b (a type of medication used in the trial)
  • People who show any signs of liver cirrhosis (scarring of the liver)
  • People who are also infected with hepatitis A, C, D, or E viruses, or HIV
  • People who have other liver conditions, such as liver disease caused by alcohol, medications, an autoimmune condition, or an inherited metabolic disorder
  • People who have serious health problems affecting major organs such as the heart, lungs, kidneys, brain, or eyes
  • People with autoimmune diseases, poorly controlled diabetes, or thyroid conditions (overactive or underactive thyroid)
  • People with confirmed or suspected liver cancer or any other cancer
  • People who have had an organ transplant or are planning to have one
  • People whose blood test results show low white blood cell or platelet counts (below specific levels — confirm with trial site)
  • People currently taking medications that suppress the immune system
  • People who are pregnant, planning to become pregnant in the near future, or currently breastfeeding
  • People who drink heavily on a regular basis (above defined daily limits) or who have a history of drug addiction
  • People with a current or past history of mental health or psychological conditions
  • People who the trial investigators consider unsuitable for the study for other reasons

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 27 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Zhiliang Gao, Doctor, Third Affiliated Hospital, Sun Yat-Sen University

Phone: +86 13632434363

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 4
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Registry
ClinicalTrials.gov
Start date
8 January 2022
Est. completion
13 December 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

HBsAg clearance rate

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: 27 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