Drugs / HyperRAB
HyperRAB
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07399951 | Oct 2023 → Jun 2025 | — | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT02912845 | Aug 2016 → Nov 2019 | rabies | Kamada, Ltd. | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2/3 | NCT03264157 Comparator | Dec 2017 → Mar 2018 | — | Bio Products Laboratory | Completed | Met primary |
| Phase 3 | NCT03965962 Background | Jul 2019 → Dec 2020 | — | Sanofi Pasteur, a Sanofi Company | Completed | Met primary |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2020-08-19 | Kamada, Ltd. | Results Kamada and Kedrion Biopharma Announce Results of First and Only U.S. Post-Marketing Pediatric Trial of a Human Rabies Immune Globulin (HRIG); The Study Met Its Primary Objective kamada.com ↗
The Study Met its Primary Objective, Which Was to Confirm the Safety of KEDRAB in the Pediatric Population. |
| 2019-10-29 | Kamada, Ltd. | Results Kamada and Kedrion Biopharma Announce Publication of Results from the Registration Study of KEDRAB® (Rabies Immune Globulin [Human]) in Human Vaccines & Immunotherapeutics Medical Journal kamada.com ↗
KEDRAB was found to be well-tolerated with a safety profile similar to that of the comparator HRIG product. |
| 2017-08-25 | Kamada, Ltd. | Regulatory Kedrion Biopharma and Kamada Receive FDA Approval of KEDRAB™ for Post-Exposure Prophylaxis Against Rabies Infection kamada.com ↗
Kedrion Biopharmaand Kamada Ltd. (NASDAQ:KMDA) (TASE:KMDA), two leading human-derived protein therapeutics companies, today announced that KEDRAB™ [rabies immune globulin (Human)] has received U.S. Food and Drug Administration (FDA) approval for passive, transient post-exposure prophylaxis of rabies infection, when given immediately after contact with a rabid or possibly rabid animal. |
| 2016-11-07 | Kamada, Ltd. | Regulatory Kedrion Biopharma and Kamada Announce FDA Acceptance of BLA Submission for Human Rabies Immunoglobulin as a Post-Exposure Treatment kamada.com ↗
Kedrion Biopharma, and Kamada Ltd. (NASDAQ and TASE: KMDA), two leading human-derived protein therapeutics companies, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for a human anti-rabies immunoglobulin (IgG) therapy. |
| 2016-09-01 | Kamada, Ltd. | Regulatory Kamada and Kedrion Seek FDA Approval of Human Rabies Immunoglobulin as a Post-Exposure Treatment kamada.com ↗
today announced the submission of a Biological License Application (BLA) has been filed with the U.S. Food and Drug Administration (FDA) for a post-exposure treatment for rabies, a life-threatening condition. |
| 2015-12-23 | Kamada, Ltd. | Results Kamada’s Human Rabies Immune Globulin Successfully Meets Primary Endpoint in U.S. Pivotal Phase 2/3 Clinical Trial as a Post-Exposure Treatment kamada.com ↗
Top-line results showed that the primary endpoint of non-inferiority was met with a difference of -1.8% between |
All press releases naming this drug 9 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HyperRAB | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03264157 ↗ |
| Known as | HRIG | “human rabies immunoglobulin (HRIG)” NCT03965962 ↗1“KamRAB - HRIG” NCT02912845 ↗ |
| Known as | Human Rabies Immunoglobulin | “The primary purpose of this study is to confirm the safety of KamRAB (Human Rabies Immunoglobulin) in children ages 0 months to \<17 years, when administered as part of...” NCT02912845 ↗ |
| Known as | KamRAB | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02912845 ↗ |
| Known as | Rabies immune globulin (human) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03965962 ↗ |
| Modality | Protein / enzyme biologic | “Human Rabies Immunoglobulin” NCT02912845 ↗ |
| Route | Intramuscular | “wound infiltration or IM injection” NCT02912845 ↗ |