Acquired Bleeding Disorder

23
Pipeline Programs
1
Companies
25
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
3
0
16
0
4
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

1 companies ranked by most advanced pipeline stage

Novo Nordisk
Novo NordiskBAGSVAERD DENMARK, Denmark
25 programs
3
16
4
activated recombinant human factor VIIPhase 31 trial
activated recombinant human factor VIIPhase 31 trial
eptacog alfaPhase 31 trial
eptacog alfaPhase 31 trial
activated recombinant human factor VIIPhase 21 trial
+20 more programs
Active Trials
NCT00124293Completed63Est. Nov 2005
NCT01285089Completed21Est. Oct 2013
NCT01561417Completed28Est. Sep 2006
+22 more trials

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Novo Nordiskactivated recombinant human factor VII
Novo Nordiskeptacog alfa
Novo Nordiskeptacog alfa
Novo Nordiskactivated recombinant human factor VII
Novo Nordiskcatridecacog
Novo Nordiskeptacog alfa
Novo Nordiskactivated recombinant human factor VII
Novo Nordiskactivated recombinant human factor VII
Novo Nordiskeptacog alfa
Novo Nordiskactivated recombinant human factor VII
Novo Nordiskactivated recombinant human factor VII
Novo Nordiskactivated recombinant human factor VII
Novo Nordiskstandard therapy
Novo Nordiskactivated recombinant human factor VII
Novo Nordiskactivated recombinant human factor VII

Showing 15 of 25 trials with date data

Clinical Trials (25)

Total enrollment: 4,197 patients across 25 trials

NCT00323570Novo Nordiskactivated recombinant human factor VII

Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding Due to Trauma

Start: May 2006Est. completion: Jun 20070
Phase 3Withdrawn

Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding

Start: Oct 2005Est. completion: Sep 2008554 patients
Phase 3Terminated

Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

Start: May 2005Est. completion: Jan 2007829 patients
Phase 3Completed
NCT01562574Novo Nordiskactivated recombinant human factor VII

Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease

Start: Jan 2002Est. completion: Aug 200482 patients
Phase 3Completed

Multi-national Study Investigating the Effect and Safety of rFXIII on Transfusion Needs in Patients Undergoing Heart Surgery

Start: Jul 2009Est. completion: Feb 2011479 patients
Phase 2Completed

Factor VIIa in Acute Intracerebral Haemorrhage

Start: Jan 2006Est. completion: Apr 200790 patients
Phase 2Completed
NCT00123591Novo Nordiskactivated recombinant human factor VII

Safety and Preliminary Efficacy of Recombinant Activated Factor VII in Subjects With Traumatic Brain Injury

Start: Jan 2005Est. completion: May 200696 patients
Phase 2Completed
NCT00154427Novo Nordiskactivated recombinant human factor VII

Use of Activated Recombinant Human Factor VII in Cardiac Surgery

Start: Aug 2004Est. completion: Nov 2007172 patients
Phase 2Terminated

Use of Activated Recombinant FVII in Spinal Surgery

Start: Jul 2004Est. completion: Feb 200650 patients
Phase 2Completed
NCT00154492Novo Nordiskactivated recombinant human factor VII

Use of NovoSeven® in Active Variceal Bleeding

Start: Apr 2004Est. completion: Aug 2006265 patients
Phase 2Completed
NCT01601457Novo Nordiskactivated recombinant human factor VII

Activated Recombinant Human Factor VII in Pelvic-acetabular Fracture Reconstruction

Start: Sep 2002Est. completion: Apr 200448 patients
Phase 2Completed
NCT00426803Novo Nordiskactivated recombinant human factor VII

Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

Start: Aug 2002Est. completion: Jun 2004400 patients
Phase 2Completed
NCT01564563Novo Nordiskstandard therapy

Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Hematopoietic Stem Cell Transplantation

Start: Jun 2002Est. completion: Oct 200311 patients
Phase 2Terminated
NCT01563523Novo Nordiskactivated recombinant human factor VII

Efficacy and Safety of Activated Recombinant Human Factor VII in Severely Injured Trauma Patients

Start: Mar 2002Est. completion: Oct 2003283 patients
Phase 2Completed
NCT01563445Novo Nordiskactivated recombinant human factor VII

Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII for Preventing Early Hematoma Growth in Acute Intracerebral Haemorrhage

Start: Nov 2001Est. completion: Mar 200340 patients
Phase 2Completed
NCT01566786Novo Nordiskactivated recombinant human factor VII

Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII in Acute Intracerebral Haemorrhage

Start: Aug 2001Est. completion: Oct 200248 patients
Phase 2Completed
NCT01563458Novo Nordiskactivated recombinant human factor VII

Safety and Efficacy of Activated Recombinant Human Factor VII in Patients Undergoing Orthotopic Liver Transplantation

Start: Aug 2001Est. completion: Aug 2003208 patients
Phase 2Completed
NCT01601613Novo Nordiskactivated recombinant human factor VII

Activated Recombinant Human Factor VII in Patients With Dengue Haemorrhagic Fever

Start: Jul 2001Est. completion: Nov 200228 patients
Phase 2Completed
NCT01562821Novo Nordiskactivated recombinant human factor VII

Safety and Efficacy of Activated Recombinant Human Factor VII in Cirrhotic Patients Undergoing Partial Hepatectomy

Start: Jul 2001Est. completion: Dec 2002235 patients
Phase 2Completed
NCT01562158Novo Nordiskstandard therapy

Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Allogeneic Stem Cell Transplantation

Start: Apr 2001Est. completion: Oct 2003100 patients
Phase 2Completed

Safety of Recombinant Factor XIII (rFXIII) in Healthy Japanese Volunteers

Start: Jun 2010Est. completion: Aug 201024 patients
Phase 1Completed
NCT01561417Novo Nordiskactivated recombinant human factor VII

Bioequivalence of NovoSeven® and a NovoSeven® Formulation Stable at Room Temperature in Healthy Male Subjects

Start: Apr 2006Est. completion: Sep 200628 patients
Phase 1Completed

Safety of rFXIII in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass

Start: Oct 2005Est. completion: Jan 200843 patients
Phase 1Completed
NCT01285089Novo Nordiskactivated recombinant human factor VII

Observational Study on the Use of NovoSeven® for Haemostatic Treatment of Bleeding Episodes in Patients With Acquired Haemophilia

Start: Dec 2010Est. completion: Oct 201321 patients
N/ACompleted
NCT00124293Novo Nordiskactivated recombinant human factor VII

Incidence/Magnitude-Haemorrhagic Progression-Cerebral Contusions and Identification (ID) of Safety Issues After Traumatic Brain Injury

Start: Oct 2004Est. completion: Nov 200563 patients
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

4 late-stage (Phase 3) programs — potential near-term approvals
1 companies competing in this space