Phase 2 Hepatitis B Trial, Recruiting NCT06963710 Sponsor: Aligos Therapeutics Condition: Hepatitis B
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Phase 2 Hepatitis B Trial, Recruiting

NCT06963710
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 aged 18 to 65 years old (or the minimum age required by local regulations) with a body mass index (BMI) between 18.0 and 35.0 — a standard measure of body weight relative to height.
  • People who have a specific type of hepatitis B virus (HBV) marker in their blood called HBeAg-positive (for Part 1 of the trial), or HBeAg-negative (for Part 2).
  • People whose blood tests show a certain level of hepatitis B surface antigen (HBsAg) above the laboratory's minimum detectable level.
  • People whose blood tests show a hepatitis B virus level (HBV DNA) of at least 20,000 IU/mL.
  • People with a confirmed diagnosis of chronic (long-term) hepatitis B infection and liver enzyme levels (ALT) that are not more than 8 times the upper limit of the normal range during screening.
  • People who have never been treated with hepatitis B antiviral medicines or experimental HBV treatments, OR people who have not used any such treatments within the past 6 months (or longer, depending on the specific medicine).

Who may not be able to join:

  • People who also have hepatitis A, C, D, or E, or HIV, or any other significant liver disease not caused by hepatitis B.
  • People whose blood tests show antibodies against hepatitis B surface antigen (anti-HBs), which can indicate past infection or immunity.
  • People who have a current or past diagnosis of cirrhosis (severe scarring of the liver).
  • People with liver scarring (fibrosis) classified as Metavir Score F3 or higher — a medical grading scale for liver damage (confirm with trial site).
  • People who have had, or currently show signs of, the liver losing its ability to function properly (hepatic decompensation).
  • People whose liver ultrasound shows signs of liver cancer (hepatocellular carcinoma).
  • People who have taken part in another clinical trial or used an experimental medicine or device within the past 4 weeks (or longer, depending on the specific medicine).
  • People whose blood screening tests show certain abnormal results, including: liver enzyme AST levels more than 8 times the upper limit of normal; bilirubin levels more than 1.2 times the upper limit of normal (unless a condition called Gilbert's syndrome is suspected); or blood clotting ratio (INR) more than 1.2 times the upper limit of normal.

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 26 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: (800) 466-6059

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Aligos Therapeutics
Registry
ClinicalTrials.gov
Start date
15 July 2025
Est. completion
1 March 2027

Where this trial is recruiting

🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇳 China 🇫🇷 France Hong Kong 🇮🇹 Italy Moldova 🇳🇿 New Zealand 🇷🇴 Romania 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

HBeAg positive: HBV DNA <Lower Limit of Quantification [LLOQ] (10 IU/mL, target detected or target not detected); HBeAg negative: HBV DNA <Lower Limit of Quantification [LLOQ] (10 IU/mL, target not detected)

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: 26 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