Hepatitis B Trial, Recruiting NCT06323681 Sponsor: Qing XIe Condition: Hepatitis B
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Hepatitis B Trial, Recruiting

NCT06323681
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 are willing to take part voluntarily and are able to understand and sign a consent form.
  • People aged between 18 and 65 years old (inclusive).
  • People who have tested positive for the hepatitis B surface antigen (HBsAg) for at least 6 months, or have other evidence confirming chronic hepatitis B.
  • People who have previously been treated with interferon therapy, stopped that treatment at least 6 months before joining the trial, and whose HBsAg levels dropped by at least 80% by the end of their interferon treatment compared to when they started it.
  • People whose HBsAg level is 500 IU/mL or below at the screening stage, and whose HBsAg has not risen by more than 50% compared to their level at the start of their previous interferon treatment.
  • Women who could become pregnant must have a negative pregnancy test within 24 hours before the first dose, and all participants (male and female) must use effective contraception throughout the study.

Who may not be able to join:

  • Women who are pregnant, breastfeeding, or planning to have a baby during the study period.
  • People who have a personal or family history of mental health conditions, including depression, anxiety, mania, or schizophrenia.
  • People whose chronic liver disease is caused by hepatitis A, hepatitis C, hepatitis E, HIV, alcohol, medications, autoimmune conditions, or other causes not related to hepatitis B.
  • People with signs of sudden severe liver damage, indicated by significantly elevated liver enzyme (ALT) levels or high ALT combined with high bilirubin levels.
  • People with signs of advanced liver disease that the liver can no longer compensate for, such as fluid build-up in the abdomen, internal bleeding from swollen veins in the food pipe or stomach, blood poisoning, confusion caused by liver failure, or kidney failure linked to liver disease — or any past history of such complications.
  • People with evidence of liver cancer, or elevated levels of a liver cancer marker called AFP (confirm with trial site).
  • People with kidney conditions such as nephritis, kidney insufficiency, or nephrotic syndrome, or whose blood creatinine level (a kidney function marker) is above the normal upper limit at screening.
  • People whose blood test results show low levels of white blood cells (neutrophils), low platelet count, or low blood phosphorus levels (confirm with trial site for specific thresholds).
  • People with certain other health conditions, including autoimmune diseases (such as psoriasis or lupus), thyroid disease, diabetes, high blood pressure that is not well controlled by medication, serious heart disease (particularly in the past 6 months), severe eye disease, or significant problems with other vital organs.
  • People who are planning to have an organ transplant or who have already had one.
  • People who are known to be allergic to the trial drug or any of its ingredients, or for whom the trial drug is otherwise medically unsuitable.
  • People whom the trial investigators consider unsuitable 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 27 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.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Qing XIe
Registry
ClinicalTrials.gov
Start date
4 February 2024
Est. completion
1 February 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Proportion of patients with HBsAg below the lower limit of detection.

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