Phase 2 Hepatitis B Trial, Recruiting NCT05769816 Sponsor: The Second Affiliated Hospital of Chongqing Medical University Condition: Hepatitis B
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Phase 2 Hepatitis B Trial, Recruiting

NCT05769816
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 and able to sign a consent form and follow the study requirements throughout the trial
  • You are willing to use effective birth control from the time you join until 30 days after your last dose of the study drug (applies to men and women who could become pregnant)
  • You are between 18 and 70 years old, weigh at least 45 kg (if male) or at least 40 kg (if female), and have a body mass index (BMI) between 18 and 32
  • You have been diagnosed with chronic hepatitis B (CHB), whether or not you have previously taken antiviral medications for it

Who may not be able to join:

  • You have a known allergy, or are suspected to be allergic, to the study drug or any of its ingredients
  • You have taken certain medications that affect how the body processes drugs (specifically CYP3A4 inhibitors, inducers, or substrates) in the 28 days before joining (confirm with trial site)
  • You have used immune-suppressing or immune-modifying drugs, or certain cancer-related drugs, in the 6 months before joining, or received a live attenuated vaccine in the month before joining
  • You had a serious infection requiring intravenous antibiotics in the 2 weeks before joining, or currently have an infection that needs treatment
  • You have a significant liver disease caused by something other than hepatitis B
  • You have advanced liver disease with complications such as confusion caused by liver failure, fluid in the abdomen, bleeding in the food pipe, an enlarged spleen, or signs of serious liver scarring
  • You have liver cancer, a very high level of a liver cancer marker in your blood (AFP over 50 ug/L), suspicious liver findings on a scan, or another cancer diagnosed in the past 5 years (some exceptions may apply — confirm with trial site)
  • You have a history of bone fractures not caused by an injury, or have been diagnosed with osteoporosis
  • You have stomach or gut problems that could affect how well you absorb oral medications, such as severe stomach ulcers, part of your stomach removed, or ongoing nausea, vomiting, or diarrhea
  • You have a serious condition affecting your heart, lungs, kidneys, blood, immune system, mental health, or nervous system
  • You had major surgery or a serious injury in the 3 months before joining, or are planning surgery during the study
  • You donated or lost a significant amount of blood (400 mL or more) in the 3 months before joining, had a blood transfusion in the past 3 months, or donated/lost 200 mL or more of blood in the past month
  • Certain blood test or kidney function results fall outside acceptable ranges (confirm specific values with trial site)
  • You test positive for hepatitis C, HIV, or syphilis
  • You have had a problem with regular heavy alcohol use in the past 3 years (more than 20 grams of alcohol per day on average)
  • You have had a problem with drug dependence or drug abuse in the past year
  • You have taken part in another clinical trial and received an experimental drug or used an experimental medical device in the 3 months before joining
  • You are currently breastfeeding or have a positive pregnancy test at screening
  • The trial team feels there are other reasons you would not be suitable for the study (confirm with trial site)

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 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: Hong Ren, MM, The Second Affiliated Hospital of Chongqing Medical University

Phone: +86 18323409779

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
The Second Affiliated Hospital of Chongqing Medical University
Registry
ClinicalTrials.gov
Start date
10 October 2023
Est. completion
31 December 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Serum HBsAg; Serum HBsAg; Serum HBsAg; Serum HBsAg; Serum HBV DNA; Serum HBV DNA; Serum HBV DNA; Serum HBV DNA; Serum alanine aminotransferase (ALT); Serum alanine aminotransferase (ALT); Serum alanine aminotransferase (ALT); Serum alanine aminotransferase (ALT)

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