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ClinicalTrials.gov 11 recruiting now official registry

Hepatitis B clinical trials

Every US clinical trial registered for Hepatitis B — phase mix, recruiting status, and the sponsors running them, straight from the NIH ClinicalTrials.gov registry.

34 US clinical trials · 11 currently recruiting

The research picture

Hepatitis B has 34 registered US clinical trials, 11 of them open to new participants right now — about 32% of the total.

11
recruiting participants now
32%
of trials open to enrollment
8
in Phase 3–4 (later-stage)
4
top sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Counts reflect the public ClinicalTrials.gov registry as last mirrored by PlainTrial. Status and phase are reported by each study's sponsor. This is reference information, not medical advice.

Active & Recent Trials

RECRUITING 24,258 participants

Antiretroviral Pregnancy Registry (APR): Multi-sponsor Registry to Detect Any Major Teratogenic Effect Involving Any of the Registry Drugs When Administered to Pregnant People.

Syneos Health

NCT00404989

RECRUITING 8,050 participants

Evaluation of Patients With Liver Disease

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NCT00001971

RECRUITING Phase 4 5,500 participants

National Liver Cancer Screening Trial

University of Texas Southwestern Medical Center

NCT06084234

RECRUITING 1,000 participants

Blood Collection Biorepository for Liver Disease Research

State University of New York at Buffalo

NCT03025074

RECRUITING Phase 2 450 participants

Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)

GlaxoSmithKline

NCT04954859

RECRUITING Phase 4 200 participants

Comparison Between 2-dose Versus 3-dose Regimens of Heplisav B in Cirrhosis

Mercy Medical Center

NCT04588077

RECRUITING Phase 2 200 participants

Liver Cancer Disparities in American Indian and Alaska Native Persons

University of Washington

NCT05304234

RECRUITING Phase 1 37 participants

HepB mAb19 in Individuals With Chronic Hepatitis B Infection

Rockefeller University

NCT05856890

RECRUITING Phase 1 32 participants

A Study to Evaluate Blood Levels of Bepirovirsen in Adult Participants With Severe or Moderate Kidney Disease

GlaxoSmithKline

NCT07168356

RECRUITING Phase 4 12 participants

HBV Vaccination of Healthy Volunteers to Evaluate the Composition of Germinal Centers

Rockefeller University

NCT05272735

RECRUITING Phase 1 10 participants

TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B

University of Maryland, Baltimore

NCT04843852

ACTIVE NOT RECRUITING 2,990 participants

ALTUS: Performance of a Multi- Target Hepatocellular Carcinoma (HCC) Test in Subjects With Increased Risk

Exact Sciences Corporation

NCT05064553

ACTIVE NOT RECRUITING Phase 2 283 participants

A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)

GlaxoSmithKline

NCT06537414

ACTIVE NOT RECRUITING 201 participants

HBRN: Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B

University of Pennsylvania

NCT01298037

ACTIVE NOT RECRUITING Phase 2 157 participants

Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)

GlaxoSmithKline

NCT06497504

ACTIVE NOT RECRUITING 40 participants

HBRN: Immune Regulation and Costimulation in Natural History and Therapeutic Outcome of Chronic Hepatitis B

University of Pennsylvania

NCT01796457

ACTIVE NOT RECRUITING Phase 2 29 participants

Study of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants With Both Chronic Hepatitis B and HIV

National Institute of Allergy and Infectious Diseases (NIAID)

NCT05551273

ACTIVE NOT RECRUITING Phase 3 27 participants

Entecavir to TAF Switch

Thomas Jefferson University

NCT03489239

COMPLETED NA 5,004 participants

Healthy Planet Hepatitis B

University of California, Davis

NCT04503993

COMPLETED 1,076 participants

Thousand Asian American Study

University of California, Davis

NCT02596438

COMPLETED Phase 3 638 participants

B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B

National Institute of Allergy and Infectious Diseases (NIAID)

NCT04193189

COMPLETED 569 participants

Long-Term Study of Liver Disease in People With Hepatitis B and/or Hepatitis C With or Without HIV Infection

National Institutes of Health Clinical Center (CC)

NCT01350648

COMPLETED 337 participants

Hepatitis B Vaccine Genetics: A Substudy of ATN 024 and ATN 025

University of North Carolina, Chapel Hill

NCT00142740

COMPLETED 317 participants

Prevention of Recurrent Hepatitis B After Liver Transplantation

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NCT00059267

COMPLETED NA 300 participants

Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs

National Institute of Allergy and Infectious Diseases (NIAID)

NCT00013871

COMPLETED Phase 3 195 participants

Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation

Bristol-Myers Squibb

NCT00065507

COMPLETED Phase 3 69 participants

Comparative Trial of Entecavir Versus Adefovir in the Treatment of Chronic Hepatitis B Infection

Bristol-Myers Squibb

NCT00096785

COMPLETED Phase 1 49 participants

A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis B

Gilead Sciences

NCT01590641

COMPLETED Phase 1 32 participants

Simvastatin for the Treatment of Chronic Hepatitis B

Bader, Ted, M.D.

NCT00994773

COMPLETED Phase 4 19 participants

Hepsera Versus Hepsera Plus Lamivudine for Treatment of Chronic Hepatitis B in Patients With Normal ALT

University of Washington

NCT00230477

COMPLETED 17 participants

Non-invasive Biomarkers of Fibrosis in Pediatric Liver Diseases

Baylor College of Medicine

NCT01988753

COMPLETED Phase 1 10 participants

Safety and Efficacy of a Hepatitis B Vaccine in Immunosuppressed Patients

Baylor Research Institute

NCT04199715

COMPLETED Phase 2 5 participants

Pentavalent DTaP-Hep B-IPV

National Institute of Allergy and Infectious Diseases (NIAID)

NCT00133445

COMPLETED Phase 2

Study of Adding Entecavir to Current Lamivudine Therapy in HIV and HBV Co-Infected Patients

Bristol-Myers Squibb

NCT00051038

Phase Distribution

PhaseTrial count
Phase 1 6
Phase 2 7
Phase 3 4
Phase 4 4

Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.

Reading the Hepatitis B Trial Landscape

ClinicalTrials.gov lists 34 US studies indexed under Hepatitis B, and 11 of those are currently open to recruitment — roughly 32% of the total volume on the registry. That ratio is a useful proxy for activity level: a high share of recruiting studies often signals that research interest is current and that new enrollment opportunities are appearing, while a low share typically means the field is dominated by completed or follow-up work where most participant spots have already been filled. These counts reflect the public registry only and include studies at every stage of design, so they should be read as an index of research attention rather than as a measure of treatment availability.

The phase distribution for Hepatitis B shows 8 late-stage studies (Phase 3 and Phase 4 combined) alongside 13 earlier-phase entries (Phase 1 through Phase 2). Phase 1 and Phase 2 studies focus on early safety signals, dosing, and preliminary effect, while Phase 3 studies are typically the larger efficacy and safety trials submitted toward regulatory review, and Phase 4 studies follow approved interventions in real-world use. A condition weighted toward later phases often reflects a mature research pipeline with several interventions already close to or past approval, whereas a heavier early-phase tilt suggests the field is still exploring new mechanisms and candidate approaches.

Top sponsor activity for Hepatitis B is led by National Institute of Allergy and Infectious Diseases (NIAID) with 4 indexed trials, alongside 9 other organizations in the top contributor list. The list on this page surfaces up to 34 of the most relevant recent and active entries, ordered with recruiting studies first so practical options are visible. All figures are derived from the public ClinicalTrials.gov dataset maintained by the National Library of Medicine and are reproduced here for reference. Inclusion of a trial, sponsor, or intervention on this page is neither an endorsement nor a recommendation — eligibility, protocol changes, and site-level status can shift frequently, so always verify current details on ClinicalTrials.gov and consult a qualified healthcare provider before acting on anything you see here.

Frequently Asked Questions

How many clinical trials are there for Hepatitis B?

PlainTrial tracks 34 US clinical trials for Hepatitis B, of which 11 are currently recruiting participants. Data sourced from ClinicalTrials.gov.

How do I find a recruiting trial for Hepatitis B?

Use the trial list above filtered by "Recruiting" status, or visit our trial finder at /recruiting to search by condition and state. Always discuss trial participation with your healthcare provider before enrolling.

Is this data current?

Data is sourced from ClinicalTrials.gov and reflects our most recent data pull. Trial status may have changed since then. Always verify current information at ClinicalTrials.gov before making decisions about participation.

Related

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from ClinicalTrials.gov (National Library of Medicine). Consult a qualified professional before making decisions based on this data.

Source: ClinicalTrials.gov (NIH/NLM) ClinicalTrials.gov AACT registry · 2026 Trial counts and statuses sourced from ClinicalTrials.gov. Sponsor counts include both industry and federal/academic sponsors.

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