Phase 2 Hepatitis B Trial, Recruiting NCT05771402 Sponsor: The Second Affiliated Hospital of Chongqing Medical University Condition: Hepatitis B
Back to Hepatitis B

Phase 2 Hepatitis B Trial, Recruiting

NCT05771402
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 all 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; if male, you weigh at least 45 kg (about 99 lbs); if female, you weigh at least 40 kg (about 88 lbs); and your body mass index (BMI) falls between 18 and 32
  • You have 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 the research team suspects you may be allergic, to any ingredient in the study drug
  • You have taken certain medications that affect how the body processes drugs (called 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-fighting drugs, in the 6 months before joining, or received a live vaccine in the month before joining
  • You had a significant infection requiring IV antibiotics in the 2 weeks before joining, or you currently have an infection that needs treatment
  • You have a significant liver disease caused by something other than hepatitis B, as determined by the research team
  • You have advanced liver disease (such as fluid in the abdomen, brain problems from liver failure, bleeding from enlarged veins in the food pipe, or significant scarring of the liver)
  • You have liver cancer, certain elevated liver-related blood markers, signs of possible cancer in the liver on a scan, or any other cancer diagnosed within the past 5 years (with some exceptions — confirm with trial site)
  • You have a history of bone fractures related to weak bones (pathological fractures) or osteoporosis
  • You have stomach or digestive problems that could affect how your body absorbs oral medications, such as severe ulcers, significant nausea, vomiting, or diarrhea
  • You have serious ongoing disease affecting your heart, lungs, kidneys, blood, immune system, mental health, nerves, or other major body systems
  • You had a major injury or major surgery in the 3 months before joining, or you are planning surgery during the study
  • You donated or lost 400 mL (about 2 cups) or more of blood in the 3 months before joining, received a blood transfusion in the 3 months before joining, or donated/lost 200 mL or more in the month before joining
  • Certain blood test or lab results fall outside acceptable ranges, including low platelet or white blood cell counts, high bilirubin, low albumin, reduced kidney function, or abnormal clotting results (confirm specific values with trial site)
  • You test positive for hepatitis C, HIV, or syphilis
  • You have regularly consumed more than about 20 grams of alcohol per day (roughly 1.5 standard drinks) over the past 3 years
  • You have had a problem with drug dependence or drug misuse in the past year
  • You have taken part in another clinical trial and received an experimental drug or used an experimental medical device within the past 3 months
  • You are currently breastfeeding or have a positive pregnancy test at screening
  • The research team believes there are other reasons that make participation unsuitable 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 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 ALT; Serum ALT; Serum 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