Coagulation factor VIIa Recombinant Human

Overview

Recombinant human coagulation Factor VIIa (rFVIIa), intended for promoting hemostasis by activating the extrinsic pathway of the coagulation cascade. NovoSeven is a vitamin K-dependent glycoprotein consisting of 406 amino acid residues. Cloned and expressed in hamster kidney cells, the protein is catalytically active in a two-chain form.

Background

Indication

For treatment of hemorrhagic complications in hemophilia A and B.

Associated Conditions

Bleeding
Bleeding caused by Hemophilia A
Bleeding caused by Hemophilia B
Severe Bleeding

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Retrospective Experience Assessing the Real-World Utilization and Effectiveness of SEVENFACT®	2023/06/15	NCT05904210	N/A	Completed	Laboratoire français de Fractionnement et de Biotechnologies
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	2023/01/25	NCT05695391	Phase 3	Recruiting	Laboratoire français de Fractionnement et de Biotechnologies
NovoSeven® in Severe Postpartum Haemorrhage - Experiences From UK, DK, FR, NL	2021/01/26	NCT04723979	N/A	Completed	Leiden University Medical Center
SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis	2020/09/24	NCT04563520	Phase 3	Recruiting	Emory University
Clinical Outcomes of NovoSeven® Treatment in Severe Postpartum Haemorrhage - a Study at the University Hospital of Bern	2020/06/24	NCT04444856	N/A	Completed	Novo Nordisk A/S
Injection of Recombinant Human Tissue-type Plasminogen Activator Derivative for Acute Pulmonary Embolism(rPA)	2019/10/01	NCT04110275	Phase 2	UNKNOWN	Angde Biotech Pharmaceutical Co., Ltd.
Recombinant Activated Factor VII in the Management of Massive Bleeding in Hospital Universiti Sains Malaysia	2017/08/16	NCT03251547	N/A	Completed	Universiti Sains Malaysia
A Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors	2017/06/22	NCT03196284	Phase 2	Completed	Novo Nordisk A/S
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants With Inhibitors	2015/12/04	NCT02622321	Phase 3	Completed	Hoffmann-La Roche
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	2015/06/29	NCT02484638	Phase 2	Terminated	CSL Behring

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
NovoSeven	Novo Nordisk A/S,Novo Allé,DK-2880 Bagsværd,Denmark	Authorised	2/23/1996

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
ACTILYSE TREATMENT-SET 50 mg/vial	BOEHRINGER INGELHEIM PHARMA GMBH & CO KG	SIN02340P	INJECTION, POWDER, FOR SOLUTION	50 mg/vial	10/3/1988

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
NOVOSEVEN RT eptacog alfa (activated) (bhk) 8mg powder for injection vial with pre-filled diluent syringe	206197	Novo Nordisk Pharmaceuticals Pty Ltd	Medicine	A	5/1/2013
NOVOSEVEN RT eptacog alfa (activated) (bhk) 1mg powder for injection vial with pre-filled diluent syringe	206194	Novo Nordisk Pharmaceuticals Pty Ltd	Medicine	A	5/1/2013
NOVOSEVEN RT eptacog alfa (activated) (bhk) 5mg powder for injection vial with pre-filled diluent syringe	206196	Novo Nordisk Pharmaceuticals Pty Ltd	Medicine	A	5/1/2013
NOVOSEVEN RT eptacog alfa (activated) (bhk) 2mg powder for injection vial with pre-filled diluent syringe	206195	Novo Nordisk Pharmaceuticals Pty Ltd	Medicine	A	5/1/2013

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