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Antihemophilic factor, human recombinant

Generic Name
Antihemophilic factor, human recombinant
Brand Names
Advate, Adynovate, Helixate, Kogenate, Kovaltry, Novoeight, Recombinate
Drug Type
Biotech
CAS Number
139076-62-3
Unique Ingredient Identifier
P89DR4NY54

Overview

Human recombinant antihemophilic factor (AHF) or Factor VIII, 2332 residues, glycosylated, produced by CHO cells

Background

Human recombinant antihemophilic factor (AHF) or Factor VIII, 2332 residues, glycosylated, produced by CHO cells

Indication

The human recombinant antihemophilic factor is indicated for use in adults and children with hemophilia A for the control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

Associated Conditions

  • Bleeding
  • Joint Damage
  • Perioperative Blood Loss

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
Pharmacokinetic Assessment of Standard Half-Life (SHL) FVIII, Extended Half-Life (EHL) FVIII, and Efanesoctocog Alfa (BIVV001) in Severe Hemophilia A
2021/09/13
NCT05042440
Phase 1
Completed
Sanofi
Pharmacokinetic Characterization of the Hemophilia A Population in Spain Using myPKFiT®
2016/12/30
NCT03006965
N/A
Completed
Spanish Society of Thrombosis and Haemostasis
A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD)
2016/10/13
NCT02932618
Phase 3
Recruiting
Baxalta now part of Shire
Safety/Efficacy Study to Assess Whether FVIII/VWF Concentrate Can Induce Immune Tolerance in Haemophilia A Patients
2015/06/23
NCT02479087
Phase 4
UNKNOWN
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Efficacy and Safety of Fanhdi®, a High-purity Von Willebrand Containing FVIII Concentrate, in Pediatric Patients With Von Willebrand Disease
2015/06/16
NCT02472665
Phase 4
Recruiting
Grifols Therapeutics LLC
International PMS Study - KOGENATE Bayer
2009/03/18
NCT00864552
N/A
Completed
Bayer
Once-A-Day Prophylaxis for Youth and Young Adults With Severe Hemophilia A
2008/07/17
NCT00717626
Phase 2
Completed
The Hospital for Sick Children
Assessment of the Risk of Inhibitor Formation in Previously Treated Patients With Severe Hemophilia A
2008/02/22
NCT00621673
Phase 4
Terminated
Bayer
BAY14-2222 Continuous Infusion in Surgeries
2008/02/01
NCT00606060
Phase 3
Completed
Bayer
BAY14-2222 Prophylaxis and Joint Function Improvement (Adults)
2008/01/04
NCT00586521
Phase 4
Completed
Bayer

FDA Drug Approvals

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

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

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.
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