Phase 2 Hepatitis B Trial, Recruiting NCT07069569 Sponsor: Ausper Biopharma Co., Ltd. Condition: Hepatitis B
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Phase 2 Hepatitis B Trial, Recruiting

NCT07069569
Recruiting Phase 2

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:

  • You are willing to take part voluntarily and able to follow the study schedule as required
  • You are between 18 and 65 years old at the time of signing the consent form
  • Your body weight is in a healthy range for your height (BMI between 18 and 30)
  • A specific hepatitis B marker in your blood (called HBeAg) tested negative at your screening visit
  • You have tested positive for hepatitis B (either HBsAg or HBV DNA) for at least 6 months
  • You have been taking a single hepatitis B antiviral tablet consistently for more than 6 months before the study screening
  • Your liver enzyme levels (ALT) are within an acceptable range (no more than twice the normal upper limit)
  • You are using effective birth control as required by the study

Who may not be able to join:

  • You are unable to be treated with Peg-IFN (a type of interferon) or a recombinant hepatitis B vaccine for medical reasons
  • You have significant health conditions beyond your chronic hepatitis B infection
  • You have another serious liver disease at the same time
  • You had a serious infection (other than hepatitis B) in the past month that required intravenous antibiotics or antiviral treatment
  • You have tested positive for hepatitis C, HIV, or syphilis
  • You have significant liver scarring (fibrosis) or cirrhosis, or your liver stiffness measurement is above a certain level
  • You have had or currently have signs of your liver failing to work properly (liver decompensation)
  • You have been diagnosed with, or are suspected of having, liver cancer, or a specific protein level in your blood (AFP) is above a certain amount
  • Your routine blood or lab test results show clearly abnormal values
  • You have a history of, or current signs of, a condition involving inflammation of blood vessels (vasculitis)
  • You have an abnormal heart rhythm reading on an ECG (specifically the QT interval)
  • You have a history of disease outside the liver that may be linked to your immune response to hepatitis B
  • You have had any cancer in the past 5 years, or are currently being checked for a possible cancer
  • You have a serious mental health condition or a history of one
  • You have had an allergic reaction to any component of the study drug, or you are known to have a tendency toward allergies (confirm with trial site)
  • You had a major injury or major surgery in the past 3 months, or you are planning surgery during the study
  • You are currently taking part in another clinical trial, or have not completed the required waiting period after a previous trial
  • You have used immune-suppressing medications in the past 3 months (with some exceptions for short or topical use), immune-modifying or chemotherapy-type drugs in the past 6 months, or had a vaccination in the past 6 months or plan to receive a live vaccine during the trial
  • You regularly take blood thinners or antiplatelet medications long-term
  • You have a thyroid condition that affects how your thyroid works
  • You have epilepsy that is not well controlled, or another progressive neurological condition
  • You have previously received a type of drug known as an antisense oligonucleotide (ASO) or an siRNA drug (confirm with trial site)
  • The study doctor decides for any other reason that the study may not be right for you

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 2: approximately ~30% 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

Principal Investigator: Jia, Beijing Friendship Hospital

Phone: 0571-86959519

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 2
Sponsor
Ausper Biopharma Co., Ltd.
Registry
ClinicalTrials.gov
Start date
8 June 2025
Est. completion
15 July 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Proportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ) at the 24th week after all treatment for CHB was discontinued.

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