Drugs / Recombinant Factor VIIa
Recombinant Factor VIIa
Trials 4 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT00123591 | Jan 2005 → May 2006 | hemorrhagic disease, traumatic brain injury | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT07227246 | May 2025 → Jan 2029 expected | intracerebral hemorrhage | Joseph Broderick, MD | Recruiting | No outcome recorded |
| Phase 3 | NCT00243243 | Jan 2006 → Jun 2011 | — | United States Army Institute of Surgical Research | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT01538160 | Feb 2012 → Jul 2015 | coagulation protein disease | Sheba Medical Center | Unknown | No outcome recorded |
Press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2008-06-11 | Novo Nordisk A/S | Novo Nordisk discontinues phase 3 clinical trial with NovoSeven® in trauma novonordisk.com ↗ |
| 2008-06-11 | Novo Nordisk A/S | Novo Nordisk indstiller klinisk fase 3-forsøg med NovoSeven® til traumebehandling novonordisk.com ↗ |
| 2007-02-26 | Novo Nordisk A/S | Phase 3 stroke trial shows that NovoSeven® reduces bleeding in the brain, but does not improve long-term clinical outcomes novonordisk.com ↗ |
| 2007-02-26 | Novo Nordisk A/S | Fase 3-forsøg inden for hjerneblødning viser, at NovoSeven® reducerer blødning, men forbedrer ikke det langsigtede behandlingsresultat novonordisk.com ↗ |
| 2005-01-04 | Novo Nordisk A/S | Novo Nordisk continues to make progress towards label expansion for NovoSeven® in Europe novonordisk.com ↗ |
| 2005-01-03 | Novo Nordisk A/S | Indikationsudvidelsen for NovoSeven® i Europa skrider fortsat fremad novonordisk.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | recombinant factor VIIa | “Recombinant factor VIIa (rFVIIa) is a hemostatic agent that has been shown to limit hemorrhage expansion and which, therefore, could potentially reduce morbidity and mortality in tICH.” PMID 18496183 ↗ Apr 2008 |
| Known as | NiaStase | “A Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Dose Escalation Study to Evaluate the Safety and Preliminary Efficacy of Recombinant Factor VIIa...” NCT00123591 ↗ |
| Known as | NovoSeven | “The purpose of the study is to see if a medication (Recombinant Coagulation Factor VIIa or NovoSeven), normally used to stop bleeding in persons with a bleeding disorder, will...” NCT00243243 ↗1“A Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Dose Escalation Study to Evaluate the Safety and Preliminary Efficacy of Recombinant Factor VIIa...” NCT00123591 ↗ |
| Known as | Recombinant Coagulation Factor VIIa | “The purpose of the study is to see if a medication (Recombinant Coagulation Factor VIIa or NovoSeven), normally used to stop bleeding in persons with a bleeding disorder, will...” NCT00243243 ↗ |
| Known as | rFVIIa | “Recombinant factor VIIa (rFVIIa) is a hemostatic agent that has been shown to limit hemorrhage expansion and which, therefore, could potentially reduce morbidity and mortality in tICH.” PMID 18496183 ↗ Apr 20081“intravenous administration of rFVIIa (Novoseven; 90 micrograms/kg, IV push, given at start of first surgical incision and again at 1 hr after start of surgery)” NCT00243243 ↗ |
| Modality | Protein / enzyme biologic | “Recombinant Coagulation Factor VIIa” NCT00243243 ↗ |
| Route | Intravenous | “intravenous administration of rFVIIa (Novoseven; 90 micrograms/kg, IV push, given at start of first surgical incision and again at 1 hr after start of surgery)” NCT00243243 ↗ |