Trial Profile
A Phase III Open-label Pharmacokinetic, Efficacy and Safety Study of rVIII-SingleChain in a Pediatric Population with Severe Hemophilia A
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 30 Jan 2023
Price :
$35
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At a glance
- Drugs Lonoctocog alfa (Primary)
- Indications Haemophilia A
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms AFFINITY
- Sponsors CSL Behring
- 28 Sep 2017 According to a CSL Behring media release, Japan's Ministry of Health, Labor and Welfare (MHLW) has approved AFSTYLA (lonoctocog alfa) for the treatment of patients with haemophilia A (congenital factor VIII deficiency). The approval was based on results from the AFFINITY clinical development program.
- 19 Apr 2017 According to a CSL Behring media release, the Australian Therapeutic Goods Administration (TGA) has approved AFSTYLA [lonoctocog alfa] in patients with haemophilia A (congenital factor VIII deficiency) based on results from trials in the AFFINITY program.
- 06 Feb 2017 Results published in the Journal of Thrombosis and Haemostasis.