Eptacog Alfa (Activated)

Summary

Eptacog Alfa (Activated) (CHEMBL2108334) is an approved protein; indicated across 10 conditions including factor vii deficiency and hemophilia a.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Protein
• Indications: 10 conditions
• Clinical trials: 71

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL2108334
Name	Eptacog Alfa (Activated)
Type	Protein
Max phase	4

Also known as: Activated recombinant human factor vii, Coagulation factor viia (recombinant), Eptacog alfa, Eptacog alfa (activado), Eptacog alfa (activated), Eptacog alfa (active), Novoseven, Recombinant activated factor vii, EPTACOG ALFA (ACTIVATED)

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

10 indications (5 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
factor VII deficiency	4	MONDO:0002244	MONDO:0002244
hemophilia A	4	MONDO:0010602	MONDO:0010602
hemophilia B	4	MONDO:0010604	MONDO:0010604
Glanzmann thrombasthenia 1	4	MONDO:0031332	MONDO:0100326
intracerebral hemorrhage	3	MONDO:0013792	EFO:0005669
hemorrhagic disease	3	MONDO:0002243	MONDO:0002243
cystitis	2	MONDO:0006032	EFO:1000025

3 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 71.

Phase distribution

Phase	Trials
Not specified	23
PHASE2	21
PHASE3	12
PHASE1	10
PHASE4	3
PHASE2/PHASE3	1
EARLY_PHASE1	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT00108797	PHASE4	COMPLETED	Trial of NovoSeven® in Haemophilia - Joint Bleeds
NCT00571584	PHASE4	COMPLETED	High Dose of Activated Recombinant Human Factor VII for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With Inhibitors
NCT01561391	PHASE4	COMPLETED	Safety and Efficacy of Activated Recombinant Human Factor VII in Haemophilia Patients With Inhibitors During and After Major Surgery
NCT00127283	PHASE3	COMPLETED	Recombinant Factor VIIa in Acute Intracerebral Haemorrhage
NCT00184548	PHASE3	TERMINATED	Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding
NCT00214656	PHASE3	UNKNOWN	Salvage Use of Recombinant Factor VIIa After Inadequate Haemostasis in Complex Cardiac Surgery
NCT00323570	PHASE3	WITHDRAWN	Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding Due to Trauma
NCT00375323	PHASE3	COMPLETED	Recombinant Factor VIIa (NovoSeven) on Restoring Coagulation Activation
NCT01392547	PHASE3	COMPLETED	Efficacy and Safety of NNC 0078-0000-0007 in Patients With Congenital Haemophilia and Inhibitors
NCT01562574	PHASE3	COMPLETED	Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease
NCT02020369	PHASE3	COMPLETED	Phase III Study of Coagulation FVIIa (Recombinant) in Congenital Hemophilia A or B Patients With Inhibitors
NCT02484638	PHASE2/PHASE3	TERMINATED	Study of Recombinant Factor VIIa Fusion Protein (rVIIa-FP, CSL689) for On-demand Treatment of Bleeding Episodes in Patients With Hemophilia A or B With Inhibitors
NCT02548143	PHASE3	COMPLETED	LR769 in Congenital Hemophilia Patients With Inhibitors Undergoing Elective Surgery or Invasive Procedures
NCT03079063	PHASE3	COMPLETED	Study Comparing the Pharmacokinetic of Biosimilar Eptacog Alfa With Novoseven®, in Patients With Congenital Factor VII Deficiency
NCT03935334	PHASE3	COMPLETED	Clinical Trial Comparing a Biosimilar Eptacog Alfa With Novoseven, in Patients With Hemophilia With Inhibitors
NCT05695391	PHASE3	TERMINATED	A Phase 3 Study of the Safety and Efficacy of Coagulation Factor VIIa (Recombinant) for the Prevention of Excessive Bleeding in Patients With Congenital Hemophilia A or B With Inhibitors to Factor VIII or IX Undergoing Elective Major Surgical Procedures SCOPE HIM
NCT00102037	PHASE2	COMPLETED	Use of Activated Recombinant FVII in Spinal Surgery
NCT00108758	PHASE2	COMPLETED	Efficacy of NovoSeven® in Bleeding Prophylaxis in Hemophilia
NCT00123591	PHASE2	COMPLETED	Safety and Preliminary Efficacy of Recombinant Activated Factor VII in Subjects With Traumatic Brain Injury
NCT00154427	PHASE2	TERMINATED	Use of Activated Recombinant Human Factor VII in Cardiac Surgery
NCT00154492	PHASE2	COMPLETED	Use of NovoSeven® in Active Variceal Bleeding
NCT00266006	PHASE2	COMPLETED	Factor VIIa in Acute Intracerebral Haemorrhage
NCT00426803	PHASE2	COMPLETED	Recombinant Factor VIIa in Acute Intracerebral Haemorrhage
NCT00486278	PHASE2	COMPLETED	Haemophilia Patients With Inhibitors Being Treated for Acute Joint Bleeds
NCT00810888	PHASE2	COMPLETED	The Spot Sign for Predicting and Treating ICH Growth Study
NCT01105546	PHASE2	UNKNOWN	rFVIIa Prophylaxis in Children With Hemophilia A and Inhibitors
NCT01561352	PHASE2	COMPLETED	Efficacy and Safety of Activated Recombinant Human Factor VII in Refractory Haemorrhagic Cystitis
NCT01562158	PHASE2	COMPLETED	Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Allogeneic Stem Cell Transplantation
NCT01562821	PHASE2	COMPLETED	Safety and Efficacy of Activated Recombinant Human Factor VII in Cirrhotic Patients Undergoing Partial Hepatectomy
NCT01563445	PHASE2	COMPLETED	Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII for Preventing Early Hematoma Growth in Acute Intracerebral Haemorrhage
NCT01563458	PHASE2	COMPLETED	Safety and Efficacy of Activated Recombinant Human Factor VII in Patients Undergoing Orthotopic Liver Transplantation
NCT01563523	PHASE2	COMPLETED	Efficacy and Safety of Activated Recombinant Human Factor VII in Severely Injured Trauma Patients
NCT01564563	PHASE2	TERMINATED	Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Hematopoietic Stem Cell Transplantation
NCT01566786	PHASE2	COMPLETED	Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII in Acute Intracerebral Haemorrhage
NCT01601457	PHASE2	COMPLETED	Activated Recombinant Human Factor VII in Pelvic-acetabular Fracture Reconstruction
NCT01601613	PHASE2	COMPLETED	Activated Recombinant Human Factor VII in Patients With Dengue Haemorrhagic Fever
NCT03196284	PHASE2	COMPLETED	A Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors
NCT00104455	PHASE1	COMPLETED	Dose Response to Recombinant Factor VIIa When Administered for Bleed
NCT01561417	PHASE1	COMPLETED	Bioequivalence of NovoSeven® and a NovoSeven® Formulation Stable at Room Temperature in Healthy Male Subjects
NCT01561924	PHASE1	COMPLETED	Prediction of the Efficacy of Activated Recombinant Human Factor VII in Adult Congenital Haemophilia A or B Patients With Inhibitors by Use of Thromboelastography

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).