eptacog alfa (activated)
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | NovoSeven | — | 1996-02-23 | europa.eu ↗ |
Trials 45 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 111 trials | ||||||
| Phase 1 | NCT04768699 | Dec 2020 → Dec 2021 | hemophilia A, hemophilia B | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT02470871 | Jul 2015 → Jul 2016 | congenital factor VII deficiency | CSL Behring | Completed | No outcome recorded |
| Phase 1 | NCT01708564 | Oct 2012 → Jun 2013 | hemophilia | rEVO Biologics | Completed | No outcome recorded |
| Phase 1 | NCT01561950 | May 2008 → Jan 2009 | vascular hemostatic disease | Novo Nordisk A/S | Terminated | No outcome recorded |
| Phase 1 | NCT00770718 | Apr 2008 → Apr 2010 | intracerebral hemorrhage | University of Utah | Terminated | No outcome recorded |
| Phase 1 | NCT01561937 | Jan 2007 → Jul 2008 | vascular hemostatic disease | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01561924 | Nov 2005 → May 2006 | hemophilia A, hemophilia B | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01562457 | Nov 2005 → Apr 2006 | hemophilia A, hemophilia B | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT00104455 | Jun → Nov 2004 | congenital hematological disorder | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01562587 | Sep 2002 → May 2003 | hemophilia A, hemophilia B | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01563471 | Oct 2001 → Jul 2002 | hemophilia A, hemophilia B | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 218 trials | ||||||
| Phase 2 | NCT00486278 | Jun 2007 → Jun 2010 | hemophilia A, hemophilia B | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 2 | NCT00266006 | Jan 2006 → Apr 2007 | acquired coagulation factor deficiency, intracerebral hemorrhage | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 2 | NCT00222625 | Sep 2005 → Sep 2006 | intracerebral hemorrhage | University Of Perugia | Unknown | No outcome recorded |
| Phase 2 | NCT00154427 | Aug 2004 → Nov 2007 | acquired coagulation factor deficiency | Novo Nordisk A/S | Terminated | No outcome recorded |
| Phase 2 | NCT00102037 | Jul 2004 → Feb 2006 | acquired coagulation factor deficiency | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 2 | NCT00154492 | Apr 2004 → Aug 2006 | cirrhosis of liver, hemorrhagic disease | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 2 | NCT00108758 | Mar 2004 → Nov 2005 | congenital hematological disorder, hemophilia A, hemophilia B | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 2 | NCT01601457 | Sep 2002 → Apr 2004 | hemorrhagic disease | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 2 | NCT00426803 | Aug 2002 → Jun 2004 | acquired coagulation factor deficiency, intracerebral hemorrhage | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 2 | NCT01564563 | Jun 2002 → Oct 2003 | acquired coagulation factor deficiency | Novo Nordisk A/S | Terminated | No outcome recorded |
| Phase 2 | NCT01563523 | Mar 2002 → Oct 2003 | hemorrhagic disease | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 2 | NCT01563445 | Nov 2001 → Mar 2003 | hemorrhagic disease, intracerebral hemorrhage | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 2 | NCT01561352 | Sep 2001 → Nov 2003 | hemorrhagic cystitis, hemorrhagic disease | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 2 | NCT01566786 | Aug 2001 → Oct 2002 | acquired coagulation factor deficiency, intracerebral hemorrhage | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 2 | NCT01563458 | Aug 2001 → Aug 2003 | hemorrhagic disease | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 2 | NCT01601613 | Jul 2001 → Nov 2002 | Dengue hemorrhagic fever, hemorrhagic disease | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 2 | NCT01562821 | Jul 2001 → Dec 2002 | cirrhosis of liver, hemorrhagic disease | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 2 | NCT01562158 | Apr 2001 → Oct 2003 | hemorrhagic disease | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 39 trials | ||||||
| Phase 3 | NCT05695391 | Jun 2024 → Jun 2025 | hemophilia | LFB | Terminated | No outcome recorded |
| Phase 3 | NCT02548143 | Aug 2016 → Aug 2017 | hemophilia | LFB | Completed | No outcome recorded |
| Phase 3 | NCT01392547 | Jul 2011 → Aug 2012 | congenital hematological disorder, hemophilia A, hemophilia B | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00323570 | May 2006 → Jun 2007 | hemorrhagic disease | Novo Nordisk A/S | Withdrawn | No outcome recorded |
| Phase 3 | NCT00184548 | Oct 2005 → Sep 2008 | hemorrhagic disease | Novo Nordisk A/S | Terminated | No outcome recorded |
| Phase 3 | NCT00214656 | Jun 2005 → Jun 2008 | blood coagulation disease, coronary artery disorder, heart valve disorder, myocardial ischemia | Austin Health | Unknown | No outcome recorded |
| Phase 3 | NCT00127283 | May 2005 → Jan 2007 | hemorrhagic disease, intracerebral hemorrhage | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01562574 | Jan 2002 → Aug 2004 | hemorrhagic disease | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00375323 | — | hemophilia A | Medical University of Vienna | Completed | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT07157423 | Aug 2025 → Mar 2027 expected | — | Novo Nordisk A/S | Recruiting | No outcome recorded |
| Phase 4 | NCT00370877 | Apr 2007 → Nov 2010 | — | Nîmes University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00284193 | Jan 2005 → Nov 2008 | hemophilia A | Sheba Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00571584 | Nov 2002 → Mar 2004 | congenital hematological disorder, hemophilia A, hemophilia B | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT00108797 | Sep 2001 → Feb 2006 | hemophilia A, hemophilia B | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT01561391 | Apr 1998 → May 2004 | congenital hematological disorder, hemophilia A, hemophilia B | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00166309 | Jul 2000 → Jun 2005 | severe hemophilia A | Skane University Hospital | Completed | No outcome recorded |
Also used as a comparator or background therapy in 14 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01949792 Comparator | Sep → Nov 2013 | congenital hematological disorder, hemophilia A, hemophilia B | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT03196284 Background | Aug 2017 → Sep 2018 | hemophilia A, hemophilia B | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 2 | NCT01359202 Comparator | May 2011 → Jun 2018 | stroke disorder | Dr. David Gladstone | Completed | No outcome recorded |
| Phase 2 | NCT01105546 Comparator | Dec 2010 → Feb 2014 | hemophilia A | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Unknown | No outcome recorded |
| Phase 2 | NCT00810888 Comparator | Nov 2010 → Apr 2016 | intracerebral hemorrhage | University of Cincinnati | Completed | No outcome recorded |
| Phase 2 | NCT00128050 Comparator | Jan 2005 → Dec 2008 | intracerebral hemorrhage | Fondazione IRCCS Policlinico San Matteo di Pavia | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT02484638 Comparator | Jul 2015 → Mar 2018 | hemophilia A, hemophilia B | CSL Behring | Terminated | No outcome recorded |
| Phase 2/3 | NCT01625390 Comparator | Jun 2012 → Mar 2014 | hemophilia A, hemophilia B | Bayer | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT04563520 Background | Jun 2026 → Mar 2027 expected | hemophilia A | Emory University | Recruiting | No outcome recorded |
| Phase 3 | NCT03496883 Comparator | Dec 2021 → Jan 2028 expected | intracerebral hemorrhage | Joseph Broderick, MD | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03935334 Comparator | Jul 2018 → Jan 2021 | hemophilia | AryoGen Pharmed Co. | Completed | No outcome recorded |
| Phase 3 | NCT03079063 Comparator | Mar 2017 → Nov 2020 | congenital factor VII deficiency | AryoGen Pharmed Co. | Completed | No outcome recorded |
| Phase 3 | NCT02622321 Background | Nov 2015 → Oct 2016 | hemophilia A | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT01800435 Comparator | Oct 2011 → Oct 2012 | hemophilia A | Oslo University Hospital | Completed | No outcome recorded |
Press releases naming this drug 11 releases
| Date | Issuer | Release |
|---|---|---|
| 2015-08-25 | CSL Behring | 20150825 rVIIa FP Phase II III Study Enrolls First Patient csl.com ↗ |
| 2013-07-03 | CSL Behring | CSL Behring Presents Phase I Results From Study of Recombinant Fusion Protein Linking Coagulation Factor VIIa with Albumin (rVIIa-FP) in Healthy Volunteers csl.com ↗ |
| 2012-03-29 | CSL Behring | CSL Behring Commences Phase I study with rVIIa-FP, a Novel Therapy to Treat People With Hemophilia A and Hemophilia B Who Have Inhibitors csl.com ↗ |
| 2012-02-16 | CSL Behring | CSL Behring Receives FDA Orphan Drug Designation for rVIIa-FP, a Novel Therapy in Development to Treat Hemophilia A and Hemophilia B Patients Who Have Inhibitors csl.com ↗ |
| 2011-05-31 | CSL Behring | CSL Behring Receives EU Orphan Drug Designations for rVIIa-FP for Hemophilia A and B Treatment csl.com ↗ |
| 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 22 cited values
Every value below carries the sentence it was read from. 82 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | eptacog alfa (activated) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00184548 ↗ |
| Known as | activated recombinant coagulation factor VII | “Activated recombinant coagulation factor VII (rFVIIa, NovoSeven®) in Patients With Major Fractures of Pelvis or Pelvis and Acetabulum Undergoing Repair Surgery” NCT01601457 ↗ |
| Known as | Activated Recombinant Factor VII | “Randomised, Double-Blind, Placebo-Controlled, Multicentre, Dose-Escalation Study to Evaluate the Safety and Preliminary Efficacy of Activated Recombinant Factor VII...” NCT01566786 ↗8“Randomised, Double-Blind, Placebo Controlled, Multi-Centre, Parallel Groups Confirmatory Efficacy and Safety Trial of Activated Recombinant Factor VII (NovoSeven®/Niastase®) in...” NCT00127283 ↗ “Pilot study to test the efficacy and safety of activated recombinant factor VII (NovoSeven) in the treatment of refractory hemorrhagic cystitis following high-dose chemotherapy.” PMID 17133240 ↗ Dec 2006 “A multicentred randomised, double blind, placebo-controlled trial evaluating the efficacy and safety of activated recombinant factor VII (rVIIa) in complex cardiac surgery.” NCT00214656 ↗ “We conducted a multicentre, randomized trial of the efficacy and safety of activated recombinant factor VII (rFVIIa, NovoSeven) in the treatment of bleeding following HSCT.” PMID 16102099 ↗ Sep 2005 “Activated Recombinant Factor VII (rFVIIa/NovoSeven®/ NiaStase®) in the Treatment of Refractory Bleeding in Severely Injured Trauma Patients” NCT00323570 ↗ “We studied the efficacy and safety of activated recombinant factor VII (rFVIIa) in reducing transfusion requirements in OLT.” PMID 16035095 ↗ Aug 2005 “activated recombinant factor VII (rFVIIa; NovoSeven)” PMID 16757825 ↗ 2006 “Activated Recombinant Factor VII (rFVIIa/NovoSeven®)” NCT01562821 ↗ |
| Known as | activated recombinant human factor VII | “activated recombinant human factor VII (rFVIIa)” NCT01601613 ↗20“activated recombinant human factor VII” NCT00102037 ↗ |
| Known as | AryoSeven | “A single dose of eptacog alfa biosimilar (AryoSeven) 90 μg/kg or 270 μg/kg.” NCT03935334 ↗ |
| Known as | Coagulation Factor VIIa (Recombinant) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05695391 ↗ |
| Known as | eptacog alfa | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03935334 ↗ |
| Known as | Factor VIIa | “The primary endpoint is the evaluation of efficacy of Factor VIIa (Eptacog alfa, NovoSeven, Novo Nordisk) on rebleeding after surgery for primary supratentorial ICH.” NCT00128050 ↗1“rFVIIa (recombinant activated factor VIIa; 80 μg/kg)” PMID 36756899 ↗ Feb 2023 |
| Known as | Niastase | “A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII...” NCT00184548 ↗3“A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®/...” NCT01563523 ↗ “Randomised, Double-Blind, Placebo Controlled, Multi-Centre, Parallel Groups Confirmatory Efficacy and Safety Trial of Activated Recombinant Factor VII (NovoSeven®/Niastase®) in...” NCT00127283 ↗ “Activated Recombinant Factor VII (rFVIIa/NovoSeven®/ NiaStase®) in the Treatment of Refractory Bleeding in Severely Injured Trauma Patients” NCT00323570 ↗ |
| Known as | NovoSeven | “A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Dose Exploratory Trial Evaluating the Safety and Efficacy of Activated Recombinant Factor VII...” NCT01563458 ↗27“A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII...” NCT00184548 ↗ “A Multi-center, Randomized, Double-blind, Parallel Groups, Placebo-controlled Trial on Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the...” NCT01564563 ↗ “Evidence suggests greater doses of recombinant activated factor VII (rFVIIa; NovoSeven, Novo Nordisk A/S, Bagsvaerd, Denmark) than currently administered may result in enhanced...” PMID 18081834 ↗ Dec 2007 “A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®/...” NCT01563523 ↗ “Randomised, Double-Blind, Placebo-Controlled, Multicentre, Dose-Escalation Study to Evaluate the Safety and Preliminary Efficacy of Activated Recombinant Factor VII...” NCT01566786 ↗ “Randomised, Double-Blind, Placebo Controlled, Multi-Centre, Parallel Groups Confirmatory Efficacy and Safety Trial of Activated Recombinant Factor VII (NovoSeven®/Niastase®) in...” NCT00127283 ↗ “An Open Label Pilot Study to Test the Efficacy and Safety of Recombinant Factor VIIa (rFVIIa, NovoSeven®) in the Treatment of Refractory Hemorrhagic Cystitis Following High...” NCT01561352 ↗ “rFVIIa (NovoSeven®) for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With Inhibitors: A Double-blind Study of a Single High Dose Versus Standard Multiple...” NCT00571584 ↗ “the study will compare the effects of a drug called recombinant activated factor VII (NovoSeven®) or rFVIIa with a placebo to determine which is better for reducing ICH growth.” NCT00810888 ↗ “We conducted a multicentre, randomized trial of the efficacy and safety of activated recombinant factor VII (rFVIIa, NovoSeven) in the treatment of bleeding following HSCT.” PMID 16102099 ↗ Sep 2005 “The primary endpoint is the evaluation of efficacy of Factor VIIa (Eptacog alfa, NovoSeven, Novo Nordisk) on rebleeding after surgery for primary supratentorial ICH.” NCT00128050 ↗ “the aim of this trial is to determine the pharmacokinetics of activated recombinant human factor VII (NovoSeven®) in haemophiliac patients in a non-bleeding state.” NCT01562587 ↗ “following two intravenous administrations of the same dose of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Haemophilia Patients in a Non-bleeding State” NCT01562457 ↗ “Activated recombinant coagulation factor VII (rFVIIa, NovoSeven®) in Patients With Major Fractures of Pelvis or Pelvis and Acetabulum Undergoing Repair Surgery” NCT01601457 ↗ “Activated Recombinant Factor VII (rFVIIa/NovoSeven®/ NiaStase®) in the Treatment of Refractory Bleeding in Severely Injured Trauma Patients” NCT00323570 ↗ “Recombinant Activated Factor VII (rFVIIa/NovoSeven) Dose Response Trial” NCT00104455 ↗ “NovoSeven 90 µg/kg i.v NovoSeven 90 µg/kg i.v + Cyklokapron 20 mg/kg” NCT01800435 ↗ “A single dose of eptacog alfa (Novoseven) 90 μg/kg or 270 μg/kg.” NCT03935334 ↗ “Activated Recombinant Factor VIIa (rFVIIa/NovoSeven®)” NCT01563471 ↗ “activated recombinant factor VII (rFVIIa; NovoSeven)” PMID 16757825 ↗ 2006 “Activated Recombinant Factor VII (rFVIIa/NovoSeven®)” NCT01562821 ↗ “Use of NovoSeven® in Active Variceal Bleeding” NCT00154492 ↗ “Eptacog alfa (NovoSeven)” NCT07157423 ↗ |
| Known as | recombinant activated coagulation factor VII | “OBJECTIVE: To investigate whether recombinant activated coagulation factor VII (rFVIIa) reduces hemorrhage expansion among patients with spot sign-positive ICH.” PMID 31424491 ↗ Dec 2019 |
| Known as | recombinant activated factor VII | “Evidence suggests greater doses of recombinant activated factor VII (rFVIIa; NovoSeven, Novo Nordisk A/S, Bagsvaerd, Denmark) than currently administered may result in enhanced...” PMID 18081834 ↗ Dec 200714“In this randomized, placebo-controlled, double-blind, single-centre, dose escalation study, we report the first evaluation of the pharmacokinetics and safety of recombinant...” PMID 15870545 ↗ Jun 2005 “The purpose of this study was to assess the cost-effectiveness of recombinant activated factor VII (rFVIIa) as adjunctive therapy for the control of bleeding in patients with...” PMID 26814938 ↗ Jul 2007 “We performed this phase 3 trial to confirm a previous study in which recombinant activated factor VII (rFVIIa) reduced growth of the hematoma and improved survival and...” PMID 18480205 ↗ May 2008 “Safety and hemostatic effect of recombinant activated factor VII in cirrhotic patients undergoing partial hepatectomy: a multicenter, randomized, double-blind, placebo-controlled trial.” PMID 16442954 ↗ Feb 2006 “Control of bleeding in children with Dengue hemorrhagic fever using recombinant activated factor VII: a randomized, double-blind, placebo-controlled study.” PMID 16269927 ↗ Nov 2005 “Evidence suggests that recombinant activated factor VII (rFVIIa) can decrease intractable bleeding in patients after cardiac surgery.” PMID 19546387 ↗ Jun 2009 “We sought to determine whether recombinant activated factor VII (rFVIIa) can reduce hematoma growth after intracerebral hemorrhage.” PMID 15728810 ↗ Feb 2005 “Recombinant activated factor VII for acute intracerebral hemorrhage: US phase IIA trial.” PMID 16757825 ↗ 2006 “nine RCTs of recombinant activated factor VII (rFVIIa) versus placebo/open control” PMID 37870112 ↗ Oct 2023 |
| Known as | recombinant activated factor VIIa | “rFVIIa (recombinant activated factor VIIa; 80 μg/kg)” PMID 36756899 ↗ Feb 2023 |
| Known as | Recombinant Factor VIIa | “FEIBA (factor VIII inhibitor-bypassing activity), an activated prothrombin complex concentrate (aPCC), and NovoSeven, recombinant factor VIIa (rFVIIa), are used as hemostatic...” PMID 16990605 ↗ Sep 20069“Bolus infusion (BI) recombinant factor VIIa (rFVIIa) administration is safe and effective in the surgical management of haemophilia patients with inhibitors but has not been...” PMID 17938794 ↗ Oct 2007 “An Open Label Pilot Study to Test the Efficacy and Safety of Recombinant Factor VIIa (rFVIIa, NovoSeven®) in the Treatment of Refractory Hemorrhagic Cystitis Following High...” NCT01561352 ↗ “Recombinant factor VIIa as adjunctive therapy for bleeding control in severely injured trauma patients: two parallel randomized, placebo-controlled, double-blind clinical trials.” PMID 16096533 ↗ Jul 2005 “The purpose of this study is to evaluate the treatment of Recombinant Factor VIIa (eptacog alfa (activated)) in patients with acute intracerebral bleeding.” NCT00127283 ↗ “We evaluated the hemostatic effect and safety of recombinant factor VIIa (rFVIIa) in cirrhotic patients undergoing partial hepatectomy.” PMID 16442954 ↗ Feb 2006 “Evaluation of efficacy and safety of recombinant factor VIIa versus standard therapy in preventing early haematoma growth” NCT00222625 ↗ “"Salvage Use" of Recombinant Factor VIIa After Inadequate Haemostasis in Complex Cardiac Surgery” NCT00214656 ↗ “Activated Recombinant Factor VIIa (rFVIIa/NovoSeven®)” NCT01563471 ↗ “Recombinant Factor VIIa (NovoSeven)” NCT00375323 ↗ |
| Known as | recombinant FVIIa | “with one to three doses of recombinant FVIIa (rFVIIa) at 90 lg kg(-1) in the treatment of acute joint bleeds in hemophilia patients with inhibitors.” PMID 22470921 ↗ Jan 2012 |
| Known as | recombinant human factor VIIa | “Case reports on recombinant human factor VIIa (rhuFVIIa) use in women with severe postpartum hemorrhage (PPH) showed encouraging results” PMID 25594352 ↗ Mar 2015 |
| Known as | rFVIIa | “A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII...” NCT00184548 ↗31“A Multi-center, Randomized, Double-blind, Parallel Groups, Placebo-controlled Trial on Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the...” NCT01564563 ↗ “Evidence suggests greater doses of recombinant activated factor VII (rFVIIa; NovoSeven, Novo Nordisk A/S, Bagsvaerd, Denmark) than currently administered may result in enhanced...” PMID 18081834 ↗ Dec 2007 “In this randomized, placebo-controlled, double-blind, single-centre, dose escalation study, we report the first evaluation of the pharmacokinetics and safety of recombinant...” PMID 15870545 ↗ Jun 2005 “FEIBA (factor VIII inhibitor-bypassing activity), an activated prothrombin complex concentrate (aPCC), and NovoSeven, recombinant factor VIIa (rFVIIa), are used as hemostatic...” PMID 16990605 ↗ Sep 2006 “Bolus infusion (BI) recombinant factor VIIa (rFVIIa) administration is safe and effective in the surgical management of haemophilia patients with inhibitors but has not been...” PMID 17938794 ↗ Oct 2007 “The purpose of this study was to assess the cost-effectiveness of recombinant activated factor VII (rFVIIa) as adjunctive therapy for the control of bleeding in patients with...” PMID 26814938 ↗ Jul 2007 “An Open Label Pilot Study to Test the Efficacy and Safety of Recombinant Factor VIIa (rFVIIa, NovoSeven®) in the Treatment of Refractory Hemorrhagic Cystitis Following High...” NCT01561352 ↗ “We performed this phase 3 trial to confirm a previous study in which recombinant activated factor VII (rFVIIa) reduced growth of the hematoma and improved survival and...” PMID 18480205 ↗ May 2008 “the study will compare the effects of a drug called recombinant activated factor VII (NovoSeven®) or rFVIIa with a placebo to determine which is better for reducing ICH growth.” NCT00810888 ↗ “We conducted a multicentre, randomized trial of the efficacy and safety of activated recombinant factor VII (rFVIIa, NovoSeven) in the treatment of bleeding following HSCT.” PMID 16102099 ↗ Sep 2005 “following two intravenous administrations of the same dose of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Haemophilia Patients in a Non-bleeding State” NCT01562457 ↗ “To investigate whether recombinant activated coagulation factor VII (rFVIIa) reduces hemorrhage expansion among patients with spot sign-positive ICH.” PMID 31424491 ↗ Dec 2019 “with one to three doses of recombinant FVIIa (rFVIIa) at 90 lg kg(-1) in the treatment of acute joint bleeds in hemophilia patients with inhibitors.” PMID 22470921 ↗ Jan 2012 “Activated Recombinant Factor VII (rFVIIa/NovoSeven®/ NiaStase®) in the Treatment of Refractory Bleeding in Severely Injured Trauma Patients” NCT00323570 ↗ “Evidence suggests that recombinant activated factor VII (rFVIIa) can decrease intractable bleeding in patients after cardiac surgery.” PMID 19546387 ↗ Jun 2009 “Activated recombinant factor VII (rFVIIa) promotes hemostasis at sites of vascular injury and may minimize hematoma growth after ICH.” PMID 15569871 ↗ Nov 2004 “We sought to determine whether recombinant activated factor VII (rFVIIa) can reduce hematoma growth after intracerebral hemorrhage.” PMID 15728810 ↗ Feb 2005 “We studied the efficacy and safety of activated recombinant factor VII (rFVIIa) in reducing transfusion requirements in OLT.” PMID 16035095 ↗ Aug 2005 “activated recombinant coagulation factor VII (rFVIIa; NovoSeven in children with haemophilia A” PMID 15230949 ↗ Jul 2004 “two recombinant factor VIIa (rFVIIa) dose regimens for treating haemarthroses” PMID 16601828 ↗ Apr 2006 “Recombinant Activated Factor VII (rFVIIa/NovoSeven) Dose Response Trial” NCT00104455 ↗ “activated recombinant factor VII (rFVIIa; NovoSeven)” PMID 16757825 ↗ 2006 “Activated Recombinant Factor VII (rFVIIa/NovoSeven®)” NCT01562821 ↗ “activated recombinant human factor VII (rFVIIa)” NCT01601613 ↗ “Recombinant Activated Factor VII (rFVIIa)” NCT00770718 ↗ |
| Known as | rhFVIIa | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01708564 ↗ |
| Known as | rVIIa | “This randomised placebo controlled study will test the hypothesis that Recombinant Activated Factor VII (rVIIa) will improve haemostasis after an inadequate response to...” NCT00214656 ↗ |
| Action | Restore | “Administration of rFVIIa but not placebo restored the preoperative prolonged prothrombin time to normal value during surgery.” PMID 16035095 ↗ Aug 2005 |
| Modality | Protein / enzyme biologic | “Recombinant activated factor VII” PMID 17906567 ↗ Oct 2007 |
| Route | Intravenous | “to be administered bolus i.v. (intravenous) over approx. three hours.” NCT00184548 ↗ |