Diseases / Hepatitis B
Hepatitis B
DiseaseHepatitis B is a viral liver infection caused by the hepatitis B virus that can present as acute or chronic disease. Chronic infection can lead to cirrhosis, liver failure, and hepatocellular carcinoma. Transmission occurs through blood and body fluids, including perinatal, sexual, and parenteral routes.
- Trials
- 998
- Recruiting
- 60
- Completed
- 601
- With results
- 206
Last revised
Pipeline
Phase by status
| Phase | Recruiting | Not yet | By invitation | Active | Completed | Terminated | Withdrawn | Suspended | Unknown | No longer available | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Early Phase 1 | — | 1 | — | — | — | — | — | — | 1 | — | 2 |
| Phase 1 | 10 | 2 | — | 1 | 61 | 6 | — | — | 4 | — | 84 |
| Phase 1/2 | — | — | — | — | 14 | 2 | 1 | — | 2 | — | 19 |
| Phase 2 | 5 | 6 | — | 4 | 79 | 20 | 3 | — | 12 | — | 129 |
| Phase 2/3 | — | — | — | 1 | 9 | 1 | 1 | — | 1 | — | 13 |
| Phase 3 | 1 | 6 | — | 3 | 149 | 14 | 1 | — | 7 | — | 181 |
| Phase 4 | 5 | 6 | 2 | 1 | 98 | 2 | 4 | — | 55 | — | 173 |
| Not applicable | 8 | 9 | — | 2 | 75 | 5 | 7 | — | 38 | — | 144 |
| Unknown | 31 | 9 | 2 | 8 | 116 | 6 | 4 | 1 | 74 | 2 | 253 |
Trials started per year
Conditions studied, by phase
| Condition | Early Phase 1 | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | Phase 4 | Not applicable | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Hepatitis B | 2 | 84 | 19 | 129 | 13 | 181 | 173 | 144 | 253 | 998 |
| Hepatitis B, Chronic | 1 | 24 | 7 | 38 | 1 | 18 | 29 | 16 | 28 | 162 |
| Tetanus | — | 2 | — | 21 | 2 | 54 | 12 | 8 | 6 | 105 |
| Hepatitis C | — | 3 | 2 | 6 | 1 | 3 | 3 | 29 | 57 | 104 |
| Diphtheria | — | 2 | — | 20 | 2 | 55 | 12 | 5 | 5 | 101 |
| Haemophilus Infections | — | 2 | — | 17 | 2 | 45 | 10 | 5 | 1 | 82 |
| Whooping Cough | — | 2 | — | 10 | 2 | 41 | 7 | 6 | 4 | 72 |
| Poliomyelitis | — | 2 | — | 16 | 2 | 35 | 5 | 3 | 5 | 68 |
| HIV Infections | — | — | 2 | 7 | 1 | 8 | 7 | 14 | 23 | 62 |
| Carcinoma, Hepatocellular | 1 | 3 | 1 | 7 | 2 | 1 | 6 | 11 | 27 | 59 |
Most active sponsors
| # | Sponsor | Trials | Phase 3 |
|---|---|---|---|
| 1 | GlaxoSmithKline | 140 | 56 |
| 2 | Sanofi Pasteur, a Sanofi Company | 28 | 23 |
| 3 | Gilead Sciences | 22 | 5 |
| 4 | National Taiwan University Hospital | 19 | 1 |
| 5 | Merck Sharp & Dohme LLC | 17 | 15 |
| 6 | Third Affiliated Hospital, Sun Yat-Sen University | 17 | 0 |
| 7 | National Institute of Allergy and Infectious Diseases (NIAID) | 15 | 2 |
| 8 | Dynavax Technologies Corporation | 13 | 5 |
| 9 | Bristol-Myers Squibb | 12 | 3 |
| 10 | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | 12 | 3 |
Most studied interventions
| # | Intervention | Trials |
|---|---|---|
| 1 | entecavir | 82 |
| 2 | Tenofovir | 80 |
| 3 | Hepatitis B Vaccines | 72 |
| 4 | Engerix-B | 46 |
| 5 | peginterferon alfa-2a | 31 |
| 6 | diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine | 25 |
| 7 | Lamivudine | 25 |
| 8 | tenofovir alafenamide | 23 |
| 9 | adefovir dipivoxil | 22 |
| 10 | Blood Specimen Collection | 15 |
Evidence
- Results reported
- 34.3%206 of 601 completed
- Published
- 12.5%75 of 601 completed
- Primary endpoint met
- 69%78 of 113 analyses
- Median months to report
- 17
Documents disclosed
Trial profile
- Median enrollment
- 178
- Median duration
- 26.8months
- Countries
- 97
- Study sites
- 4534
Who is enrolled
Median enrollment by phase
- Early Phase 1
- 140
- Phase 1
- 36
- Phase 1/2
- 33
- Phase 2
- 96
- Phase 2/3
- 120
- Phase 3
- 267
- Phase 4
- 183
- Not applicable
- 204
- Unknown
- 334
Where trials run
Busiest cities
| # | City | Country | Trials |
|---|---|---|---|
| 1 | Guangzhou | China | 63 |
| 2 | Seoul | South Korea | 61 |
| 3 | Beijing | China | 60 |
| 4 | Toronto | Canada | 59 |
| 5 | San Francisco | United States | 50 |
| 6 | New York | United States | 47 |
| 7 | Taipei | Taiwan | 46 |
| 8 | Bangkok | Thailand | 44 |
| 9 | Los Angeles | United States | 43 |
| 10 | London | United Kingdom | 42 |
Terminations
- Terminated
- 56
- Withdrawn
- 21
- Suspended
- 1
- Stopped for recruitment
- 0.6%6 of 998 trials
Stated reasons
Reasons are grouped from the sponsor's own wording with a rule-based classifier; the original text is shown below.
Recently stopped
| Trial | Status | Stated reason | Stopped |
|---|---|---|---|
| NCT06097312 Withdrawn | Withdrawn | Company out of business | 2032-03-31 |
| NCT04046107 Withdrawn | Withdrawn | Temporarily closed to enrollment | 2027-09-30 |
| NCT05482282 Withdrawn | Withdrawn | The products will be replace with others. | 2026-12-31 |
| NCT05330455 Terminated | Terminated | The study was terminated as a strategic decision | 2026-04-08 |
| NCT06082336 Terminated | Terminated | Liquidation of MagIA Diagnostics | 2026-03-24 |
| NCT02605538 Withdrawn | Withdrawn | Time and resource deficiency at the Stockholm CF Center. | 2025-12-31 |
| NCT05272735 Terminated | Terminated | The yield of cells recovered from the lymph node fine needle aspirations was low limiting the ability to perform the planned immunologic assessments following HBV vaccination. | 2025-09-29 |
| NCT03692897 Terminated | Terminated | Study Closure | 2025-09-10 |
| NCT05404919 Withdrawn | Withdrawn | Insufficient enrollment; departure of primary investigator from institution | 2024-08-01 |
| NCT03534141 Terminated | Terminated | Terminated 9/24/23 at 85% target enrollment due to slow accrual of subjects. The decline in enrollment was attributed to changing surgical demographics (higher MELD, more DCD grafts, and increasing use of Normothermic Perfusion technology). | 2023-09-14 |
Trial records
Individual study records live on ClinicalTrials.gov. A sample of the trials counted above: