A Phase I/III Open-label, Multicenter, Crossover Safety, Efficacy and Pharmacokinetic Study of Recombinant Coagulation Factor VIII (rFVIII) Compared to Recombinant Human Antihaemophilic Factor VIII (rFVIII; INN: Octocog Alfa) in Subjects With Hemophilia A, and a Repeat PK, Safety and Efficacy Study
Phase of Trial: Phase III
Latest Information Update: 01 Jul 2019
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At a glance
- Drugs Lonoctocog alfa (Primary) ; Octocog alfa
- Indications Haemophilia A
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms AFFINITY
- Sponsors CSL Behring
- 01 Jul 2019 According to a CSL Behring media release, data from this study will be presented at this year's International Society on Thrombosis and Haemostasis (ISTH) Congress (Melbourne, Australia, 6th-10th, July, 2019).
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History