Hepatitis B Trial, Recruiting NCT05661786 Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Condition: Hepatitis B
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Hepatitis B Trial, Recruiting

NCT05661786
Recruiting Not Applicable

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 who have tested positive for the hepatitis B surface antigen (a marker of hepatitis B infection) for more than 6 months
  • People who are 18 years of age or older
  • People who have never previously been treated for hepatitis B
  • People whose hepatitis B is in a specific stage, shown by a particular pattern of blood markers (HBeAg negative and anti-HBe positive)
  • People with a hepatitis B viral load (the amount of virus in the blood) above a certain level (above 2000 IU/mL)
  • People whose liver enzyme levels (ALT) have consistently been within the normal range
  • People whose liver shows low levels of inflammation and scarring, as measured by biopsy or a liver stiffness test, meeting specific thresholds set by the trial (confirm with trial site)
  • People with no family history of liver cirrhosis or liver cancer

Who may not be able to join:

  • People who also have an active infection with hepatitis A, C, D, or E virus, or HIV
  • People who have liver cancer or any other cancer, or who have an elevated level of a tumour marker called alpha-fetoprotein at the time of enrolment
  • People who already have liver cirrhosis (severe liver scarring)
  • People who have drunk heavily in the past year (above certain daily alcohol limits based on sex) or heavily in the two weeks before enrolment, or who have a history of drug abuse
  • People who have taken part in another clinical trial within the last 3 months
  • People who have an autoimmune liver disease (where the immune system attacks the liver)
  • People who are pregnant, planning to become pregnant in the near term, or currently breastfeeding
  • People with a history of severe heart disease or mental illness
  • People with diabetes, high blood pressure, thyroid problems, eye disease (retinopathy), or autoimmune conditions that are not well controlled
  • People whose blood counts for certain immune cells (neutrophils) or platelets fall below specific levels (confirm with trial site)
  • People who have had an organ transplant in the past or are preparing for one
  • People who are currently taking immunosuppressive medications (drugs that reduce immune system activity)
  • People whom the trial investigators consider unsuitable for the study 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 21 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 86-25-83105890

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

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Registry
ClinicalTrials.gov
Start date
1 December 2022
Est. completion
1 February 2028

Where this trial is recruiting

🇨🇳 China

Primary endpoints

The incidence of hepatocellular carcinoma at 240 weeks; The HBsAg clearance rate at 240 weeks

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: 21 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