Phase 2 Hepatitis B Trial, Recruiting NCT06295328 Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Condition: Hepatitis B
Back to Hepatitis B

Phase 2 Hepatitis B Trial, Recruiting

NCT06295328
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 between 18 and 60 years old
  • You have been diagnosed with chronic hepatitis B (a long-term liver infection) for more than 6 months, confirmed by blood tests, and your virus levels fall into one of two specific ranges (the trial team will check which group you belong to)
  • You may test positive or negative for a specific hepatitis B marker called HBeAg (the trial team will check this)
  • Either you are not currently taking any antiviral medications (Group A), or you have been taking only the antiviral drug tenofovir for more than 6 months (Group B)
  • Your liver is healthy, based on a series of blood tests and a liver stiffness scan (Fibroscan®) showing a score of 7.0 or below
  • Your body weight is within a healthy range for your height, with a BMI between 17.0 and 35.0
  • Your general blood and chemistry test results are within normal or acceptable ranges, as judged by the study doctor
  • If you are a woman who could become pregnant, you must not be pregnant or breastfeeding at the time of screening
  • If you are a woman who could become pregnant or a man who has not been surgically sterilised, you must be willing to use reliable contraception throughout the study
  • You have not had any serious health problems in the last 3 months that could affect your safety or the study results
  • You are willing and able to give written consent to take part in the study

Who may not be able to join:

  • You have liver cirrhosis (scarring of the liver), either currently or in the past
  • You have an active liver disease other than chronic hepatitis B
  • You are also infected with hepatitis C, hepatitis D, hepatitis E, or HIV
  • You have an active hepatitis A infection at the time of screening
  • Your kidneys are not working well enough (confirm with trial site)
  • You currently have or have had in the past a condition called psoriasis or lupus
  • You are taking certain medicines that interact with a liver enzyme called CYP2D6, that can harm the liver, or that are known to interact with the study drug terbinafine (such as rifampicin) (confirm with trial site for specific medications)
  • You are taking a type of blood pressure or circulation medication called an L-type calcium channel blocker (such as lomerizine or nifedipine)
  • You are taking, or have taken within the last 4 months, medications that suppress or modify your immune system (such as interferon)
  • You have been diagnosed with substance abuse involving drugs (such as narcotics or cocaine) or alcohol in the last 12 months, or you regularly drink more than 14 units of alcohol per week (men) or more than 7 units per week (women)
  • You are unable to understand the study information well enough to make an informed decision about taking part

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: +31205662422

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
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Registry
ClinicalTrials.gov
Start date
13 April 2022
Est. completion
1 April 2025

Where this trial is recruiting

🇳🇱 Netherlands

Primary endpoints

Change in level of serum HBsAG; Change in serum HBV DNA

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