Drugs / Antithrombin III
Antithrombin III
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04055389 | Jan 2021 → Feb 2022 | cirrhosis of liver, portal vein thrombosis | Jonathan Stine | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 24 trials · 1 met primary | ||||||
| Phase 2 | NCT04899232 | Jul 2021 → Mar 2022 | COVID-19, blood coagulation disease | Enrique Ginzburg | Terminated | No outcome recorded |
| Phase 2 | NCT02103114 | Jun 2014 → Jun 2016 | hereditary antithrombin deficiency | Duke University | Completed | No outcome recorded |
| Phase 2 | NCT01886248 | Jun 2013 → Aug 2021 | hepatic veno-occlusive disease | Seoul National University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT00823082 | Jun 2009 → Jun 2011 | acquired coagulation factor deficiency | Grifols | Completed | Met primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT01530737 | Nov 2011 → Oct 2014 | — | The Hospital for Sick Children | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT04219579 | Jan 2020 → Jun 2022 | — | Seoul National University Hospital | Completed | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 1 | NCT02631174 Comparator | Jun 2015 → Jun 2018 | — | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| Phase 1 | NCT01698567 Comparator | Jul 2012 → Mar 2016 | congenital heart disease | University of Rochester | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02251041 Comparator | Sep 2014 → Feb 2019 | — | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Phase 3 | NCT05662319 Background | Feb 2023 → Mar 2027 expected | hemophilia | Sanofi | Active not recruiting | No outcome recorded |
| Phase 4 | NCT01201070 Comparator | Sep 2009 → Nov 2011 | acute coronary syndrome, aortic valve insufficiency, aortic valve stenosis, mitral valve insufficiency +1 | University of Bari | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2025-11-18 | Grifols Therapeutics LLC | Regulatory Grifols receives expanded indication for THROMBATE III® (antithrombin III [human]) label in U.S., strengthening treatment options for pediatric patients grifols.com ↗
the United States Food and Drug Administration (FDA) has approved an expanded indication for THROMBATE III ® , the company’s antithrombin III [human concentrate], to include pediatric patients diagnosed with hereditary antithrombin deficiency (hATd). |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-11-18 | Grifols Therapeutics LLC | Grifols receives expanded indication for THROMBATE III® (antithrombin III [human]) label in U.S., strengthening treatment options for pediatric patients grifols.com ↗ |
| 2022-02-24 | Grifols Therapeutics LLC | Grifols signs global collaboration agreement with Endpoint Health to develop and commercialize Antithrombin III for Sepsis grifols.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Antithrombin Ⅲ | “Antithrombin III (ATC code: B01AB02)” NCT05662319 ↗ |
| Known as | antithrombin | “pharmacologic prophylaxis with intravenous antithrombin (AT-III)” NCT04055389 ↗ |
| Known as | AT-III | “administration of Antithrombin III (ATIII) on the activation of the coagulation system” NCT01201070 ↗1“pharmacologic prophylaxis with intravenous antithrombin (AT-III)” NCT04055389 ↗ |
| Known as | ATIIIC | “Antithrombin concentrate (ATIIIC)” NCT05662319 ↗ |
| Action | Restore | “The purpose of this research study is to see if participants who have SARS-CoV-2 and low levels of AT3 in the blood will benefit by being given AT3.” NCT04899232 ↗ |
| Modality | Protein / enzyme biologic | “Patients in the antithrombin group received a dose of purified antithrombin to reach an antithrombin activity value of 120%” PMID 23102903 ↗ Oct 2012 |
| Route | Intravenous | “intravenous antithrombin III” NCT02251041 ↗ |