Phase 2 Hepatitis B Trial, Recruiting NCT06425341 Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. Condition: Hepatitis B
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Phase 2 Hepatitis B Trial, Recruiting

NCT06425341
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:

  • People with a body mass index (a measure of body weight relative to height) between 18.5 and below 35
  • People who have had a chronic hepatitis B infection documented for at least 6 months before the screening visit
  • People whose hepatitis B virus levels in the blood are currently undetectable or below measurable levels due to antiviral treatment
  • People who have been taking a single approved antiviral medication for hepatitis B (from a class called nucleoside or nucleotide analogues) for at least 24 weeks before joining, with no change in dose for at least 4 weeks before joining
  • People who are willing and able to use effective contraception during the trial
  • People who are willing to sign a consent form agreeing to participate

Who may not be able to join:

  • People with a history of liver cirrhosis, liver failure, suspected or confirmed liver cancer, or other liver diseases besides chronic hepatitis B
  • People with an autoimmune disease (where the immune system attacks the body)
  • People who have had a solid organ transplant or a bone marrow/stem cell transplant
  • People with serious heart or brain blood vessel conditions that are unstable or not well controlled
  • People diagnosed with any cancer in the 5 years before joining the trial
  • People who have had an infection requiring medical treatment in the 2 weeks before joining
  • People who have had a major injury or major surgery in the 12 weeks before joining, or who have planned surgery or other treatments during the trial period that investigators believe could affect the results
  • People whose blood test results during the screening period showed significant abnormalities
  • People whose heart electrical activity test (ECG) showed a specific abnormal reading (called prolonged QTcF) or other results that could pose a safety risk
  • People with a history of drug use, alcohol misuse, or substance abuse in the 12 months before joining
  • People who have recently taken part in another clinical drug trial
  • People who are pregnant or breastfeeding
  • People who are allergic to any ingredient in the trial medication
  • People who are considered ineligible for other reasons, as determined by the trial investigators

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

Phone: 0518-82342973

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
Fujian Shengdi Pharmaceutical Co., Ltd.
Registry
ClinicalTrials.gov
Start date
6 June 2024
Est. completion
30 August 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

PartA:Change in mean log10 serum hepatitis B surface antigen levels from baseline at week 12; PartB:Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48; PartC:Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48; PartD:Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48

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