10 completed, 4 unknown, 3 withdrawn, 2 recruiting. 6 Phase 2, 5 Phase 4, 4 Phase 3, 2 Not applicable, 1 Early Phase 1.
Follow hepatitis B hyperimmune globulin: new trials by email Literature Review of hepatitis B hyperimmune globulin trials Research Report on hepatitis B hyperimmune globulin
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Immunomodulatory Therapy and Predictors of Clinical Cure in Chronic Hepatitis B Hepatitis B Immunoglobulin (HBIg) - Chronic Hepaititis B | Early Phase 1 | Recruiting | Peking University People's Hospital | 132 | 2026-01-01 | 2026-01-09 |
| Combined Light, ExVivo, and Antivirals for Recipients of Lungs From HBV Donors Entecavir, HBIG, EVLP UV Light Treatment - Hepatitis B Virus (HBV), Lung Transplant Recipient | Phase 4 | Recruiting | University Health Network, Toronto | 20 | 2025-09-24 | 2025-11-17 |
| Utilization of Hepatitis B Virus NAT+ Donors for Hepatitis B Vaccinated Lung Transplant Candidates Hepatitis B Immune Globulin and entecavir, tenofovir disoproxil, or tenofovir alafenamide - Lung Transplant, Hepatitis B | Phase 2 | Withdrawn | University of Pennsylvania | 2022-09-06 | 2024-08-06 | |
| Treatment of Patients With Chronic Hepatitis B With Hepatitis B Immunoglobulins Human hepatitis B Immunoglobulin (Hepatect®CP/Zutectra®) - Chronic Hepatitis B | Phase 2 | Terminated | Hannover Medical School | 13 | 2022-08-15 | 2025-09-04 |
| Maternal Therapy With TAF Versus TDF to Prevent Vertical Transmission of Hepatitis B Tenofovir Alafenamide 25 MG for arm (A), Tenofovir Disoproxil Fumarate 300mg for arm (B) - Hepatitis B, Chronic, Pregnancy Related | Unknown | New Discovery LLC | 450 | 2020-01-27 | 2020-12-29 | |
| Hepatitis B Immune Globulin (HBIg) to Restore Immune Control in People With Chronic Hepatitis B hepatitis B immune globulin (HBIg), Pegylated interferon alfa (pegIFN) - Chronic Hepatitis B | Phase 2 | Withdrawn | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | 2019-02-13 | 2022-04-06 | |
| Stop Hep B @ Birth Tenofovir Disoproxil Fumarate 300 mg daily; HBV birth dose vaccine; hepatitis B immune globulin (HBIG), Regular Myanmar treatment - Hepatitis B | Not applicable | Unknown | Myanmar Liver Foundation | 110 | 2018-07-01 | 2021-08-10 |
| Tenofovir Disoproxil Fumarate in Combination of Hepatitis B Vaccine for Preventing Hepatitis B Vertical Transmission Tenofovir Disoproxil Fumarate (TDF) 300 mg oral daily. - Hepatitis B Infection, Congenital Malformation | Phase 4 | Unknown | New Discovery LLC | 280 | 2018-06-10 | 2019-12-12 |
| A Study of the Interruption on the Mother-to-child Transmission of Hepatitis B Virus （HBV MTCT）in Newborns at High Risk 200 IU HBIG - Chronic Hepatitis B | Unknown | Beijing Ditan Hospital | 406 | 2015-07-01 | 2016-09-20 | |
| A Clinical Trial of Zutectra in Patients Who Recently Received a Liver Transplant Zutectra - Hepatitis B | Phase 3 | Completed | Biotest | 49 | 2012-12-01 | 2015-03-25 |
| Prevention for Mother-to-infant Transmission of HBV Hepatitis B immunoglobulin - HBV | Not applicable | Completed | Xi'an Jiaotong University | 28 | 2012-05-01 | 2014-12-09 |
| Efficacy and Safety of Niuliva® for the Prevention of Hepatitis B Virus Recurrence in Newly Orthotopic Liver Transplant Recipients Hepatitis B immune globulin - Hepatitis B, Liver Transplantation | Phase 3 | Completed | Instituto Grifols, S.A. | 15 | 2010-07-01 | 2016-02-25 |
| Nabi-HB Administered Subcutaneously in Patients With Hepatitis B Virus Post Liver Transplantation Nabi-HB - Hepatitis B, Chronic | Phase 3 | Withdrawn | Biotest Pharmaceuticals Corporation | 2010-04-01 | 2016-01-18 | |
| Evaluating Blood Glucose Levels During Infusion With HepaGam B (HBIG) in Post-liver Transplant Patients glucose monitoring before and after HepaGam B administration, HepaGam B (Hepatitis B Immune Globulin (HBIG)) - Hepatitis B | Phase 4 | Completed | Georgetown University | 5 | 2009-10-01 | 2015-09-28 |
| Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients HepaGam B - Hepatitis B, Liver Transplantation | Phase 4 | Completed | Cangene Corporation | 9 | 2008-02-01 | 2013-11-01 |
| Truvada Versus Truvada Plus Hepatitis B Immunoglobulin (HBIg) in Prevention of Chronic Hepatitis B Recurrence Post Liver Transplant FTC/TDF, Hepatitis B Immunoglobulin (HBIg) - Chronic Hepatitis B | Phase 2 | Completed | Gilead Sciences | 40 | 2007-09-01 | 2014-03-14 |
| The Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Health Neonates Experimental recombinant hepatitis B vaccine, HBIG, Active Comparator hepatitis B vaccine, Experimental recombinant hepatitis B vaccine - Virus Disease, DNA Virus Infections | Phase 3 | Completed | Jiangsu Province Centers for Disease Control and Prevention | 1740 | 2007-04-01 | 2010-09-17 |
| LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B With/Without HBIg in Newborns to HBeAg+ Mothers Engerix™ -B, Hepatitis B immunoglobulin (HBIg) - Hepatitis B | Phase 4 | Completed | GlaxoSmithKline | 79 | 2003-10-01 | 2016-12-07 |
| Prevention of Recurrent Hepatitis B After Liver Transplantation HBIG, Epivir, Hepsera - Hepatitis B, Cirrhosis | Completed | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | 317 | 2001-03-01 | 2024-11-15 | |
| Pilot Study to Assess the Pharmacokinetics of Intravenous Nabi 5% Hepatitis B Immune Globulin (Boca HBVIg) Used in Combination With Lamivudine for Patients With Hepatitis B Virus (HBV) Associated Liver Disease Undergoing Liver Transplantation Hepatitis B Immune Globulin (Boca HBVIg) - Hepatitis B Virus Associated Liver Disease | Phase 1 / Phase 2 | Completed | Biotest Pharmaceuticals Corporation | 30 | 1999-11-01 | 2019-01-22 |
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Hepatitis B (12) · Hepatitis B, Chronic (6) · Carcinoma, Hepatocellular (1) · Congenital Abnormalities (1) · DNA Virus Infections (1) · Fibrosis (1) · Hepadnaviridae Infections (1) · Liver Diseases (1) · Liver Failure, Acute (1) · Persistent Infection (1) · Recurrence (1) · Reinfection (1) · Viremia (1) · Virus Diseases (1)
Biotest Pharmaceuticals Corporation (2) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (2) · New Discovery LLC (2) · Beijing Ditan Hospital (1) · Biotest (1) · Cangene Corporation (1) · Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) (1) · Georgetown University (1) · Gilead Sciences (1) · GlaxoSmithKline (1) · Hannover Medical School (1) · Instituto Grifols, S.A. (1) · Jiangsu Province Centers for Disease Control and Prevention (1) · Myanmar Liver Foundation (1) · Peking University People's Hospital (1)
United States (8) · China (5) · Canada (2) · France (2) · Germany (2) · Italy (2) · Spain (2) · United Kingdom (2) · Burma (1) · Israel (1) · New Zealand (1) · Thailand (1)
Adam K Richards, MD (1) · Andrew M Courtwright, MD, PhD (1) · Anna Lok, M.D. (1) · Anna S Lok, MD (1) · Calvin Pan, MD (1) · Calvin Q Pan, MD (1) · Consuelo Soldevila-Pico, M.D. (1) · Didier Samuel, Professeur (1) · Donald Jensen, M.D. (1) · Erhei Dai, MD (1) · Heiner Wedemeyer, Prof. (1) · Khin Phone Kyi, MD (1) · Kirti Shetty, MD (1) · Lewis Teperman, MD (1)
PMID 20346062, PMID 22662137, PMID 22777097, PMID 39540799
U01DK057577 (1)