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Condition Guide

New Treatments & Clinical Trials for Hepatitis B

Last updated August 2026Data from ClinicalTrials.gov204 active trials
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Hepatitis B affects roughly 300 million people worldwide. Current treatment includes antiviral pills like tenofovir and entecavir that suppress the virus but rarely eliminate it, meaning most people stay on medication indefinitely. A functional cure — where the virus stays dormant without ongoing treatment — remains the central goal.

What's actually going on in research

Trials are testing combination therapies that pair antivirals with immune-boosting drugs, agents that silence viral DNA in infected liver cells, and therapeutic vaccines designed to train the immune system to control the virus long-term. Researchers are also studying capsid inhibitors that block viral assembly and RNA-targeting therapies that disrupt viral replication at earlier steps.

Combination therapies

Pairing antivirals with drugs that stimulate immune response or silence viral genes may achieve functional cure in a meaningful percentage of people. Several combinations are now in mid-stage trials.

Capsid inhibitors

These drugs prevent the virus from assembling properly inside liver cells. Early results suggest they reduce viral markers more effectively than antivirals alone when used in combination.

RNA-targeting therapies

Drugs that degrade or silence viral RNA aim to shut down replication at an earlier stage than current antivirals. Some use small interfering RNA or antisense oligonucleotides.

What to know before you search

Eligibility typically depends on viral load, liver enzyme levels, presence of cirrhosis, prior antiviral treatment, and hepatitis B e-antigen status.

What types of trials are currently open

  • Functional cure trials — Testing combination therapies to see if people can stop daily antivirals and keep the virus suppressed long-term. These trials often measure hepatitis B surface antigen loss as a marker of cure.
  • Antiviral trials — Testing new drugs that block viral replication, often capsid inhibitors or RNA-targeting agents, usually in combination with existing antivirals.
  • Immune-based trials — Testing therapeutic vaccines or immune-stimulating drugs that aim to restore the body's ability to control the virus without ongoing medication.
  • Prevention trials — Testing vaccines or long-acting antivirals in people at high risk of infection, including infants born to mothers with hepatitis B.
  • Liver disease trials — Testing treatments for cirrhosis, liver cancer, or liver damage caused by chronic hepatitis B, including drugs that reduce fibrosis.

Recently added Hepatitis B trials

RecruitingSafety & dosing / Early efficacy

Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)

This is a Phase I/II, double-blind, randomized, active controlled, multi-centric clinical trial to assess the reactogenicity, safety and immunogenicity of a SIIPL DTwP-HepB-rPV-Hib vaccine in comparison with HEXASIIL® in healthy toddlers and infants. This trial is planned as a Phase I/II trial with two age cohorts to be enrolled sequentially, starting with healthy toddlers and subsequently extending to healthy infants. In Phase I of the trial, after at least one parent signs the informed consent and the participant's eligibility is confirmed, healthy toddlers aged 12-24 months will be randomized in a 2:1 ratio, to receive 0.5 mL of either of the vaccines intramuscularly in the upper anterolateral aspect of the thigh. Following vaccination, all toddlers will be observed at the site for minimum 30 (+15) minutes for any Iimmediate Adverse Event (IAE). Solicited Adverse Events (AEs) will be actively collected for 7 days post vaccination. Unsolicited AEs and Serious AEs will be collected throughout the trial from the time of signing informed consent till 28 days post vaccination. Blood samples for immunogenicity assessment will be obtained from all participating toddlers at Visit 1 (Prior to vaccination) and at Visit 4. A Data Safety Monitoring Board (DSMB) meeting will be convened for the evaluation of 7-day safety data in all participants. The DSMB shall review the safety data and provide recommendations to initiate Phase II of the trial. Additionally, Safety Review Comitte (SRC) will review the 24-hour safety data from the initial sentinel group (three participants) and give advice on progression to the subsequent enrolment in Phase I. After at least one parent signs the informed consent and the participant's eligibility is confirmed, all infants will be randomized in 2:1 ratio to receive a 3-dose primary vaccination series at 6, 10 and 14 weeks of age. Each participant will receive 0.5 mL of either vaccine intramuscularly in the upper anterolateral aspect of the thigh. Following each vaccination, all infants will be observed at the site for minimum 30 (+15) minutes for any IAEs. Active follow up for solicited AEs will be conducted over the 7-day period after each vaccination. Unsolicited AE/SAEs will be collected from signing of informed consent till Visit 10. Blood samples for immunogenicity assessment will be obtained from all participating infants at Visit 1 (Prior to vaccination) and at Visit 10.

Dhaka, Bangladesh
RecruitingObservational study

Share your health experiences in a hepatitis B study

This single-center comparative cross-sectional study includes a prospective longitudinal follow-up cohort. At least 400 subjects from the "Everest Project" cohort will be enrolled into four groups: clinical-cure, non-cure, relapse, and healthy control. Data will be collected via online/offline questionnaires with internationally-standardized scales. This study aims to first systematically characterize the psychosocial value of chronic hepatitis B clinical cure, advance the shift from biomedical to biopsychosocial holistic health model, and provide scientific evidence for patient-management optimization and stigma-reduction public-health policy-making.

Guangzhou, China
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