activated recombinant human factor VII
Trials 19
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| 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 211 trials · 5 missed | ||||||
| Phase 2 | NCT00154427 | Aug 2004 → Nov 2007 | acquired coagulation factor deficiency | Novo Nordisk A/S | Terminated | Missed primary Stop: Enrollment |
| 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 | Missed primary |
| Phase 2 | NCT01564563 | Jun 2002 → Oct 2003 | acquired coagulation factor deficiency | Novo Nordisk A/S | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01563523 | Mar 2002 → Oct 2003 | hemorrhagic disease | Novo Nordisk A/S | Completed | Mixed |
| 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 | Missed primary |
| Phase 2 | NCT01562821 | Jul 2001 → Dec 2002 | cirrhosis of liver, hemorrhagic disease | Novo Nordisk A/S | Completed | Missed primary |
| Phase 2 | NCT01562158 | Apr 2001 → Oct 2003 | hemorrhagic disease | Novo Nordisk A/S | Completed | Missed primary |
| Phase 32 trials · 1 missed | ||||||
| Phase 3 | NCT00323570 | May 2006 → Jun 2007 | hemorrhagic disease | Novo Nordisk A/S | Withdrawn | No outcome recorded |
| Phase 3 | NCT01562574 | Jan 2002 → Aug 2004 | hemorrhagic disease | Novo Nordisk A/S | Completed | Missed primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT00571584 | Nov 2002 → Mar 2004 | congenital hematological disorder, 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 |
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 11 cited values
Every value below carries the sentence it was read from. 32 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | activated recombinant human factor VII | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01562821 ↗ |
| 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 ↗6“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 “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®)” NCT01562821 ↗ “activated recombinant factor VII (rFVIIa; NovoSeven)” PMID 16757825 ↗ 2006 |
| 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 (rFVIIa/NovoSeven®/...” NCT01563523 ↗1“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 ↗14“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 ↗ “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 ↗ “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 ↗ “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 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 ↗ |
| Known as | recombinant activated factor VII | “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 20054“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 “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 “Evidence suggests that recombinant activated factor VII (rFVIIa) can decrease intractable bleeding in patients after cardiac surgery.” PMID 19546387 ↗ Jun 2009 “Recombinant activated factor VII for acute intracerebral hemorrhage: US phase IIA trial.” PMID 16757825 ↗ 2006 |
| Known as | recombinant factor VIIa | “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 20074“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 “We evaluated the hemostatic effect and safety of recombinant factor VIIa (rFVIIa) in cirrhotic patients undergoing partial hepatectomy.” PMID 16442954 ↗ Feb 2006 “Activated Recombinant Factor VIIa (rFVIIa/NovoSeven®)” NCT01563471 ↗ |
| Known as | rFVIIa | “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 ↗15“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 “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 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 ↗ “Activated Recombinant Factor VII (rFVIIa/NovoSeven®/ NiaStase®) in the Treatment of Refractory Bleeding in Severely Injured Trauma Patients” NCT00323570 ↗ “Activated recombinant factor VII (rFVIIa) promotes hemostasis at sites of vascular injury and may minimize hematoma growth after ICH.” PMID 15569871 ↗ Nov 2004 “Evidence suggests that recombinant activated factor VII (rFVIIa) can decrease intractable bleeding in patients after cardiac surgery.” PMID 19546387 ↗ Jun 2009 “We studied the efficacy and safety of activated recombinant factor VII (rFVIIa) in reducing transfusion requirements in OLT.” PMID 16035095 ↗ Aug 2005 |
| 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 | “activated recombinant factor VII (rFVIIa/NovoSeven®)” NCT00108758 ↗ |
| Route | Intravenous | “80 mcg/kg is administered i.v.” NCT01561352 ↗ |