Drugs / hepatitis B immune globulin
hepatitis B immune globulin
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Zutectra | — | 2009-11-30 | europa.eu ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 23 trials | ||||||
| Phase 2 | NCT05345990 | Aug 2022 → Jul 2025 | chronic hepatitis B virus infection | Hannover Medical School | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03575208 | Feb 2019 → Mar 2022 | chronic hepatitis B virus infection | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00228592 | ? → Aug 2005 | hepatitis B virus infection | Merck & Co., Inc. | Terminated | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT01856413 | Dec 2012 → Sep 2014 | hepatitis B virus infection | Biotest | Completed | No outcome recorded |
| Phase 3 | NCT01513850 | Oct 2010 → Mar 2014 | hepatitis B virus infection | SK Chemicals Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT01131065 | Jul 2010 → Jun 2014 | hepatitis B virus infection | Grifols | Completed | No outcome recorded |
| Phase 3 | NCT00000580 | Nov 1975 → Jun 1986 | hepatitis B virus infection | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07189377 | Sep 2025 → Aug 2027 expected | hepatitis B virus infection | University Health Network, Toronto | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT04998838 | Jul 2018 → Dec 2021 | hepatitis B virus infection | Myanmar Liver Foundation | Unknown | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 2 | NCT05404919 Background | Sep 2022 → Aug 2024 | hepatitis B virus infection | University of Pennsylvania | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2/3 | NCT03519113 Comparator | Mar 2018 → Mar 2022 | hepatitis B virus infection | Green Cross Corporation | Unknown | No outcome recorded |
| Phase 3 | NCT01183611 Comparator | Apr 2007 → Jun 2010 | Hepadnaviridae infectious disease | Jiangsu Province Centers for Disease Control and Prevention | Completed | No outcome recorded |
| Phase 4 | NCT02417207 Comparator | Apr 2015 → Apr 2018 | hepatitis B virus infection | Third Affiliated Hospital, Sun Yat-Sen University | Unknown | No outcome recorded |
| — | NCT01139203 Comparator | Aug 2009 → Dec 2012 | hepatitis B virus infection | Shanghai Jiao Tong University School of Medicine | Unknown | No outcome recorded |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | hepatitis B immune globulin | “A total of 205 neonates were assigned to treatment with high-titer hepatitis B immune globulin, standard immune globulin, or albumin placebo within 72 hours of delivery.” NCT00000580 ↗6“hepatitis B immune globulin (HBIG)” NCT02417207 ↗ |
| Known as | HBIG | “The purpose of this study is to Evaluate the efficacy and safety of Hepabulin IV (HBIG, a study drug) after liver transplantation.” NCT01513850 ↗9“hepatitis B immune globulin (HBIG)” NCT04998838 ↗ “hepatitis B immune globulin (HBIg)” NCT03575208 ↗ “Hepatitis B Immune Globulin (HBIG)” NCT05404919 ↗ “Hepatitis B Immune Globulin (HBIg)” NCT00228592 ↗ |
| Known as | Hepabulin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01513850 ↗ |
| Known as | HepatectCP | “Human hepatitis B Immunoglobulin (Hepatect®CP/Zutectra®)” NCT05345990 ↗ |
| Known as | Human hepatitis B Immunoglobulin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05345990 ↗ |
| Known as | Zutectra | “Human hepatitis B Immunoglobulin (Hepatect®CP/Zutectra®)” NCT05345990 ↗ |
| Modality | Protein / enzyme biologic | “hepatitis B immune globulin with a high level of antibody against the hepatitis B antigen” NCT00000580 ↗ |
| Route | Intravenous | “immunoglobulins, intravenous” NCT00000580 ↗ |