Hepatitis B Trial, Recruiting NCT05195450 Sponsor: Institute of Liver and Biliary Sciences, India Condition: Hepatitis B
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Hepatitis B Trial, Recruiting

NCT05195450
Recruiting Not Applicable

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 test positive for the hepatitis B surface antigen (a marker showing hepatitis B is present in the body)
  • People whose liver enzyme levels (ALT) have stayed within the normal range over two separate tests, taken 3 to 6 months apart — normal is below 30 IU/ml for males and below 20 IU/ml for females
  • People whose hepatitis B virus levels in the blood are below 2,000 IU/ml
  • People whose liver stiffness measurement (a scan that checks for liver scarring) is below 8 kPa

Who may not be able to join:

  • People who have previously been treated with antiviral medications (NUCs) or interferon therapy for hepatitis B
  • People with reduced kidney function, indicated by a blood creatinine level above 1.5 mg/dl
  • People who have been diagnosed with liver cirrhosis (severe liver scarring) or enlarged veins in the food pipe (esophageal varices)
  • People who have experienced serious complications from liver disease (confirm with trial site)
  • People who already have liver cancer (hepatocellular carcinoma)
  • People who are pregnant
  • People who work in healthcare
  • People who have had an organ transplant, have an advanced cancer diagnosis, or are currently receiving chemotherapy
  • People who also have hepatitis C, hepatitis D, or HIV

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
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 01146300000

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
Not Applicable
Sponsor
Institute of Liver and Biliary Sciences, India
Registry
ClinicalTrials.gov
Start date
23 February 2022
Est. completion
31 December 2027

Where this trial is recruiting

🇮🇳 India

Primary endpoints

Percentage of patients with HBV DNA <2000 IU/ml, normal ALT and no significant fibrosis (as per APASL 2015).

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