Phase 2 Hepatitis B Trial, Recruiting NCT07709520 Sponsor: Fujian Akeylink Biotechnology Co., Ltd. Condition: Hepatitis B
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Phase 2 Hepatitis B Trial, Recruiting

NCT07709520
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 who are able to sign a consent form and fully understand what the trial involves, including its steps and possible side effects.
  • Men and women between the ages of 35 and 65 (inclusive) who are able to complete the trial as required.
  • People who do not plan to have children within the next year, and who agree to use the specific contraceptive methods outlined in the trial protocol from the screening stage until 6 months after the last dose.
  • Men who weigh at least 50 kg and women who weigh at least 45 kg, with a body mass index (BMI) between 18 and 30 kg/m² (inclusive).
  • People who have been on a stable antiviral treatment for hepatitis B (called NA therapy) for more than 6 months, and have stayed on the same treatment regimen for at least 3 months before the screening stage.
  • People whose hepatitis B virus (HBV) levels in the blood have been sufficiently reduced, confirmed by at least two tests taken more than one week apart during the 28-day screening period, both showing HBV DNA below the minimum detectable level.
  • People who test negative for a specific hepatitis B marker (HBeAg), have a hepatitis B surface antigen (HBsAg) level between 100 and 1500 IU/mL, and have normal liver enzyme (ALT) levels during screening (confirm with trial site).
  • People who are able to communicate clearly with the clinical team and follow the trial requirements throughout.

Who may not be able to join:

  • No exclusion criteria were listed in the provided information (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 16 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: 13247651892

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 Akeylink Biotechnology Co., Ltd.
Registry
ClinicalTrials.gov
Start date
10 July 2026
Est. completion
1 October 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

HBsAg decline from baseline at D168

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: 16 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