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Home › Conditions › Hepatitis B

Hepatitis B

Part of Hepatitis

Subtypes of Hepatitis B

Acute Hepatitis B Infection 1 HBeAg-positive chronic hepatitis B virus infection 1 Hepatitis B virus-related acute-on-chronic liver failure 1

32 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials for Hepatitis B

178 trials tracked for Hepatitis B: 105 in phase 3 or 4 and 19 with published results. The most-cited published study has 316 citations.

178Trials tracked
105Phase 3 & 4
0Recruiting
19With published results
Phase distribution
Phase 4 42 Phase 3 63 Phase 2 48 Phase 1 10 Other / NA 15
  1. Phase 4 Stopping TDF Treatment After Long Term Virologic Suppression in HBeAg-negative CHB Completed · 316 cited
  2. Phase 3 Study to Evaluate Efficacy and Safety of Switching From TDF to TAF in Adults With Chronic Hepatitis B Who Are Virologically Suppressed Completed · 142 cited
  3. Phase 4 Arresting Vertical Transmission of Hepatitis B Virus Completed · 55 cited
  4. Phase 3 B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B Completed · 42 cited
  5. Phase 3 Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis B Completed · 26 cited
  6. Phase 3 Non-inferiority of GSK Biologicals' DTPw-HBV/Hib Compared to Two Formulations of GSK Biologicals' DTPw-HBV/Hib Completed · 18 cited
Show 44 more trials
  1. Phase 4 Hepatitis B Booster Study in Adolescence Completed · 16 cited
  2. Phase 4 A Randomized,Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Adults Completed · 15 cited
  3. Phase 3 Immunogenicity and Safety Study of Proquad® and Infanrix® Hexa When Administered Concomitantly (V221-035) Completed · 13 cited
  4. Phase 4 A Study to Qualify an In-house Reference Standard Batch of Sci-B-Vac™ Completed · 12 cited
  5. Phase 4 Evaluation of Immunogenicity and Safety of a Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery Completed · 12 cited
  6. Phase 3 A Bridging Study: Comparing Two Lots of Sci-B-Vac™ and Engerix-B in Healthy Adults Completed · 12 cited
  7. Phase 4 Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants Completed · 10 cited
  8. Phase 3 Safety and Immunogenicity of Recombinant Hepatitis B Vaccine Sci-B-Vac® Compared to Engerix-B® Completed · 10 cited
  9. Phase 3 Long-term Persistence of Hepatitis B and Pertussis Antibody Responses in Healthy 4 to 5 Year Old Children Previously Vaccinated With Vaxelis® or INFANRIX® Hexa (V419-012) Completed · 9 cited
  10. Phase 3 A Study to Assess the Immunogenicity and Safety of GSK Biologicals' Infanrix-IPV/Hib Vaccine Administered as a Three-dose Vaccination Course at 3, 4.5 and 6 Months of Age and a Booster Dose at 18 Months of Age in Healthy Infants in Russia Completed · 6 cited
  11. Phase 4 Vaccination Adjuved Against Hepatitis B in SNS Workers Typed as no Responders to Conventional Vaccines Completed · 4 cited
  12. Phase 3 Hepatitis B Challenge Dose in Adults (V232-059-10) Completed · 4 cited
  13. Phase 3 A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013) Completed · 3 cited
  14. Phase 4 Study to Evaluate Antibody Persistence in Children Previously Vaccinated With Infanrix Hexa™ or Infanrix-IPV/Hib™ Completed
  15. Phase 4 Effect of Risk Factors Likely to Influence Immuno of Combined Hepatitis A & B Vacc vs Monovalent Hepatitis A & B Vacc Completed
  16. Phase 4 Telbivudine or Tenofovir Treatment in HBeAg-negative Chronic Hepatitis B Patients Based on the Roadmap Concept Completed
  17. Phase 4 A Study to Evaluate Persistence of Hepatitis B Antibodies, Immunogenicity and Safety of Engerix™-B Kinder Challenge Dose, in Adolescents Vaccinated With Four Doses of Infanrix™ Hexa During Infancy Completed
  18. Phase 4 B/F/TAF Switch Study for HIV-HBV Coinfection Completed
  19. Phase 4 Evaluation of Antibody Persistence and Immune Memory Against the Hepatitis B Antigen in Previously Vaccinated Children Completed
  20. Phase 4 Long-term Persistence Study in Healthy Adults Previously Vaccinated With Twinrix Adult Completed
  21. Phase 4 A Study in Korea of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection Completed
  22. Phase 4 Evaluation of Antibody Persistence & Immune Memory in Subjects Vaccinated During Adolescence With Twinrix™ Completed
  23. Phase 4 Antibody Persistence & Immune Memory in Healthy Adults Previously Vaccinated With Twinrix Adult Completed
  24. Phase 4 Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Engerix™-B in Adults With or Without Type 2 Diabetes Mellitus Completed
  25. Phase 4 Study to Assess if Quinvaxem Can be Interchanged With Other Pentavalent Vaccines During Standard Childhood Vaccination Completed
  26. Phase 4 LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B With/Without HBIg in Newborns to HBeAg+ Mothers Completed
  27. Phase 4 Efficacy & Safety of Tenofovir Disoproxil Fumarate (TDF) Plus Peginterferon α-2a (Peg-IFN) Versus TDF or Peg-IFN Monotherapy in Chronic Hepatitis B Completed
  28. Phase 4 Immune Response to Hepatitis B Vaccine Challenge Dose in Subjects Who Received a Primary Neonatal Hepatitis B Vaccine. Completed
  29. Phase 4 Safety and Immunogenicity of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine Completed
  30. Phase 4 Immune Response of Healthy Subjects Who Received Neonatal Vaccination Course With Engerix™-B Vaccine. Completed
  31. Phase 4 Comparison of Three Hepatitis B Vaccination Regimens in HIV-Positive Youth Completed
  32. Phase 4 Evaluation of the Long-term Persistence of Immunity to Hepatitis B, in Adolescents Vaccinated in Infancy With Engerix™-B Kinder Completed
  33. Phase 4 Persistence of Immunity Against Hepatitis B in 12-13 Year Old Adolescents After Infant Hepatitis B Vaccination Completed
  34. Phase 4 Hepatitis B Antibody Persistence and Immune Response to Hepatitis B Vaccine Challenge in Previously Vaccinated Children Completed
  35. Phase 4 This Study Aims to Determine the Long-term Persistence of Antibodies Against Hepatitis B and to Evaluate the Immunogenicity and Safety of Hepatitis B Vaccine in Adolescents Vaccinated in Infancy With Infanrix™ Hexa Completed
  36. Phase 4 Adefovir Dipivoxil For The Treatment Of Chinese Compensated Chronic Hepatitis B(CHB)Patients Completed
  37. Phase 4 A Study to Evaluate Tenofovir Disoproxil Fumarate (DF) in Asian-American Adults With Chronic Hepatitis B Infection Completed
  38. Phase 4 Evaluating Blood Glucose Levels During Infusion With HepaGam B (HBIG) in Post-liver Transplant Patients Completed
  39. Phase 4 Adefovir Dipivoxil Tablets (10mg) In Chinese Subjects With HBe Antigen Negative Chronic Hepatitis B Completed
  40. Phase 4 Long Term Follow-Up Study 16-20 Years After Hepatitis B Vaccination in Newborns of Mothers Who Were Seropositive for Hepatitis B Envelope Antigen (HBeAg) & Hepatitis B Surface Antigen (HBsAg) Completed
  41. Phase 4 Study of Adefovir Dipivoxil for Korean Patients With Chronic Hepatitis B(CHB) Who Have Completed ADF 103814 Completed
  42. Phase 4 Evaluation of Immune Memory to Twinrix or Comparator by Challenge Dose Administration 4 Years After Primary Vaccination Completed
  43. Phase 4 Adefovir Dipivoxil For The Treatment Of Patients With Chronic Hepatitis B Related Advanced Fibrosis Or Cirrhosis Completed
  44. Phase 4 Challenge Dose of Hepatitis B Vaccine in Subjects Who Previously Received Engerix™-B Vaccine Completed

Showing the 50 most-cited and recently-updated of 178 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found Updated — new results For clinicians

Hepatitis B: what the trials found

Treatment with Tenofovir Disoproxil Fumarate (TDF) has been evaluated for HBsAg loss. In a study comparing TDF plus Peg-IFN against Peg-IFN alone or TDF alone, the combination of TDF and Peg-IFN showed a significantly higher percentage of participants achieving HBsAg loss at week 72 compared to both monotherapies (p < 0.001) 20. In another trial, TDF was shown to result in lower rates of HBsAg loss compared to a control group (0.236 vs 0; p=0.022) 5.

Telbivudine demonstrated high rates of viral suppression, with approximately 91% to 99% of participants achieving HBV DNA < 300 Copies/mL at week 52 15.

Various vaccines have been evaluated for efficacy and safety. Engerix-B and its variants (Engerix-B Kinder) were shown to elicit anti-HBs titers above 12 IU/L following boosters 7 and demonstrated manageable local and general symptoms in clinical settings 18. Other established vaccines include TWINRIX, Fendrix, and Infanrix hexa [11, 12, 16]. Sci-B-Vac™ showed a high percentage of subjects achieving HBs antibody titers ≥100 mIU/ml across multiple timepoints 9.

Hepatitis B Immune Globulin (HBIG) administration did not show statistically significant differences in blood glucose levels 19.

Recent results — preliminary, needs further review

  • AB-729 is currently under investigation in a Phase 2 trial 1.
  • VIR-2218 was evaluated in a Phase 2 trial regarding sustained serum HBsAg loss; however, the reported proportions were low or zero across study arms 2.
  • GS-2829 was assessed in a Phase 1 trial; results showed high rates of treatment-emergent adverse events and laboratory abnormalities, with varying levels of T-cell response increases 3.
  • A candidate vaccine adjuvanted with the AS03 system was evaluated for safety; reported administration site and systemic adverse events were generally short-lived (1-4 days) 4.

For the clinician treating this condition

  • TDF in combination with Peg-IFN is significantly more effective at inducing HBsAg loss compared to either monotherapy 20.
  • Telbivudine shows high efficacy for achieving viral suppression (HBV DNA < 300 Copies/mL) by week 52 15.
  • Multiple vaccine formulations, including Engerix-B and Infanrix hexa, are established for inducing anti-HBs antibodies and providing protection [7, 11, 22].

AI synthesis of 11 cited trials, updated Jun 26, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
Elevated serum M2BPGi is associated with a 4.61 hazard ratio for hepatocellular carcinoma development
Rheumatology Meta-analysis
Elevated serum M2BPGi is associated with a 4.61 hazard ratio for hepatocellular carcinoma development Elevated M2BPGi Levels Linked to Higher Risk of Liver Cancer
This systematic review and meta-analysis of 12,161 participants found that elevated serum M2BPGi is significantly associated with an increas…
A large review of over 12,000 patients found that high levels of a specific protein may signal an increased risk for liver cancer.
Frontiers Jul 19, 2026
Dolutegravir and lamivudine achieved 78% HIV-1 RNA suppression in patients with isolated reactive anti-HBc
Infectious Disease RCT
Dolutegravir and lamivudine achieved 78% HIV-1 RNA suppression in patients with isolated reactive anti-HBc Trial shows dolutegravir and lamivudine are safe for patients with HIV
This pooled analysis of Phase 3/3b trials evaluated dolutegravir/lamivudine (DTG/3TC) in adults with HIV-1 and isolated reactive hepatitis B…
A review of multiple trials shows that a common two-drug regimen effectively manages HIV while remaining safe for those with hepatitis B ant…
Jul 18, 2026
JAK inhibitors are associated with higher hepatitis B virus reactivation rates than IL-12/23 or IL-17 inhibitors
Gastroenterology Meta-analysis
JAK inhibitors are associated with higher hepatitis B virus reactivation rates than IL-12/23 or IL-17 inhibitors Specific Immune Inhibitors Show Varying Risks for Hepatitis B Reactivation
This meta-analysis of 29 studies evaluated the risk of hepatitis B virus reactivation (HBVr) in patients receiving various immunomodulators.…
New analysis shows that certain immune inhibitors like JAK inhibitors may carry a higher risk of hepatitis B reactivation than other drug cl…
Jul 1, 2026
HBeAg seroclearance in HBeAg-positive chronic hepatitis B correlates with disease remission and reduced hepatocellular carcinoma risk
Infectious Disease Sys. Review
HBeAg seroclearance in HBeAg-positive chronic hepatitis B correlates with disease remission and reduced hepatocellular carcinoma risk Clearing HBeAg helps manage chronic hepatitis B and liver risk
This systematic review examines the clinical significance and optimization strategies of HBeAg seroclearance in patients with HBeAg-positive…
Achieving HBeAg seroclearance in patients with chronic hepatitis B can lead to disease remission and a lower risk of developing liver cancer…
Frontiers Jun 29, 2026
Evaluating the Impact of Digital Health Interventions on Chronic Disease Self-Care Outcomes
Physical Medicine & Rehab Meta-analysis
Evaluating the Impact of Digital Health Interventions on Chronic Disease Self-Care Outcomes Digital health tools show mixed results for managing chronic diseases
Digital tools show promise for heart failure monitoring but lack consistent evidence for improving medication adherence or general diabetes …
New data shows that while digital tools like apps can help heart failure patients monitor their health, they may not improve medication habi…
Jun 13, 2026
Epigallocatechin-3-gallate shows positive therapeutic effects on various digestive system diseases in animal models
Oncology Meta-analysis
Epigallocatechin-3-gallate shows positive therapeutic effects on various digestive system diseases in animal models Green tea compound shows potential for several digestive diseases
This meta-analysis of 63 preclinical studies involving 738 animals indicates that Epigallocatechin-3-gallate (EGCG) has a positive therapeut…
A review of animal studies suggests a green tea compound could help treat various cancers and digestive conditions.
Frontiers Jun 11, 2026
HLA-B*57:01-guided abacavir prescribing is the clearest preventive paradigm from HLA associations
Drug Pipeline Sys. Review
HLA-B*57:01-guided abacavir prescribing is the clearest preventive paradigm from HLA associations HLA genes shape HIV and hepatitis vaccine responses and drug reactions
This narrative review examines HLA polymorphisms in HIV, hepatitis C, and hepatitis B. The clearest preventive paradigm is HLA-B*57:01-guide…
A review finds that HLA genes strongly influence how people respond to HIV and hepatitis vaccines and how they react to certain medications.
Frontiers Jun 6, 2026
PEG-IFN plus novel agents may boost functional cure in chronic hepatitis B
Infectious Disease Sys. Review
PEG-IFN plus novel agents may boost functional cure in chronic hepatitis B Combination therapies may improve functional cure rates for chronic hepatitis B
This narrative review examines combining pegylated interferon-α with novel immunotherapies (antigen-reduction strategies, therapeutic vaccin…
A review suggests combining pegylated interferon with new immunotherapies could help achieve functional cure in chronic hepatitis B patients…
Frontiers Jun 6, 2026
One in six blood donors in Cameroon carries Plasmodium infection, meta-analysis finds
Infectious Disease Meta-analysis
One in six blood donors in Cameroon carries Plasmodium infection, meta-analysis finds 1 in 6 blood donors in Cameroon carries malaria parasite
A systematic review and meta-analysis of 18 studies (~12,500 donations) found a 16.6% pooled prevalence of Plasmodium spp. in Cameroonian bl…
A review of 18 studies finds 16.6% of blood donations in Cameroon contain Plasmodium, the malaria parasite.
May 30, 2026
Review of antiviral and immunotherapeutic strategies for chronic hepatitis B
Allergy & Immunology Sys. Review
Review of antiviral and immunotherapeutic strategies for chronic hepatitis B New antiviral strategies show promise for chronic hepatitis B infection
This narrative review synthesizes evidence on antiviral and immunotherapeutic strategies for chronic hepatitis B. The authors highlight func…
A review of new treatments suggests combination therapies may offer future value for managing chronic hepatitis B, cirrhosis, and liver canc…
Frontiers May 18, 2026
Meta-analysis identifies genetic variants linked to HBV susceptibility and HCC risk
Oncology Meta-analysis
Meta-analysis identifies genetic variants linked to HBV susceptibility and HCC risk Genetic Keys Unlock Why Some Get Liver Cancer From Hepatitis B
This meta-analysis of East Asian cohorts examined genetic variants associated with hepatitis B virus infection and hepatocellular carcinoma …
New research shows specific gene changes help explain why some people get Hepatitis B while others stay healthy.
May 2, 2026
Pegylated interferon alpha associated with HBsAg clearance in postpartum women with chronic HBV infection
Infectious Disease Cohort
Pegylated interferon alpha associated with HBsAg clearance in postpartum women with chronic HBV infection New treatment clears hepatitis B in 3 out of 10 women after childbirth
This prospective cohort study evaluated 263 postpartum women with chronic hepatitis B virus infection and baseline HBsAg levels ≤3000 IU/mL.
A new treatment clears hepatitis B markers in nearly 30% of women after childbirth, offering fresh hope for a functional cure during a uniqu…
Frontiers Apr 29, 2026

Research across Hepatitis

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Susceptibility-guided combination therapy improves neurological status and reduces abscess size in a patient with nocardiosis
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Susceptibility-guided combination therapy improves neurological status and reduces abscess size in a patient with nocardiosis Case report: Brain infection in autoimmune hepatitis patient
This case report describes the management of disseminated nocardiosis in a 55-year-old man with autoimmune hepatitis. The patient showed gra…
A man with autoimmune hepatitis developed a rare brain infection after immunosuppression. Doctors treated it successfully with targeted anti…
Frontiers Jul 17, 2026
Direct-acting antivirals achieve 89% sustained virologic response in patients with hepatocellular carcinoma and HCV
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This meta-analysis of 8,839 patients with hepatocellular carcinoma (HCC) and Hepatitis C virus infection found that direct-acting antivirals…
New data suggests that direct-acting antiviral drugs may improve survival and reduce cancer recurrence for people with Hepatitis C and liver…
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Autoimmune hepatitis pathogenesis shifts from single molecule to immune-metabolic network analysis
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Autoimmune hepatitis pathogenesis shifts from single molecule to immune-metabolic network analysis New Research Maps Complex Networks in Autoimmune Hepatitis
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Chronic HCV infection drives T cell dysfunction, regulatory T cell accumulation, and metabolic defects that persist after viral clearance
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Hepatic steatosis prevalence and impact in autoimmune hepatitis, primary biliary cholangitis, and primary sclerosing cholangitis
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Narrative review on ICIs in patients with viral infections and solid tumors
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Integrative review of Epimedium flavonoids in hepatitis and cirrhosis shows preclinical promise but lacks clinical validation
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Meta-analysis of 55 studies assesses HCV prevalence trends across Eastern Mediterranean Region populations
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Randomized trial shows ribavirin increases mutational load and specific transition signatures in HCV
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Narrative review synthesizes evidence on NAFLD, NASH, and viral hepatitis management without reported trial data Your Liver Has an Immune Army — and It Can Turn Against You
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Questions about Hepatitis B

Can hepatic steatosis make fibrosis staging less accurate in chronic hepatitis B?

Yes, hepatic steatosis can significantly reduce the accuracy of noninvasive fibrosis staging tools like APRI and FIB-4 in chronic hepatitis B patients.

Full answer →
What are the side effects of pegylated interferon-alpha for chronic hepatitis B?

Pegylated interferon-alpha for chronic hepatitis B commonly causes flu-like symptoms, bone marrow suppression, depression, and autoimmune reactions, often leading to dose adjustments.

Full answer →
Can receiving a liver transplant from a donor with Hepatitis B Virus cause infection?

Yes, a liver transplant from a donor with HBV can transmit the virus, but the risk is low (about 4%) and can be reduced with antiviral drugs and vaccination.

Full answer →
Does having Hepatitis B Virus Infection make my liver surgery more likely to fail?

Yes, active HBV infection can increase the risk of liver surgery failure, mainly due to higher chances of viral reactivation and liver damage, but antiviral therapy significantly lowers this risk.

Full answer →
Are immune checkpoint inhibitors safe for patients with Hepatitis B Virus Infection and solid tumors?

Immune checkpoint inhibitors appear safe for HBV patients with solid tumors when viral load is suppressed, but reactivation risk exists, especially during immunosuppression for immune-related adverse events.

Full answer →
How does Hepatitis B infection prevalence differ among US adults based on their race and origin?

NHANES data show that among US adults, past or present Hepatitis B infection is more common in Black adults and those born outside the US compared to White adults or those born in the US.

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See all 6 questions about Hepatitis B →

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