A Phase III Open Label, Multicenter, Extension Study to Assess the Safety and Efficacy of Recombinant Coagulation Factor VIII (rVIII-SingleChain, CSL627) in Subjects With Severe Hemophilia A
Phase of Trial: Phase III
Latest Information Update: 16 Apr 2018
At a glance
- Drugs Lonoctocog alfa (Primary)
- Indications Haemophilia A
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms AFFINITY
- Sponsors CSL Behring
- 13 Mar 2018 This trial has been completed in Czech Republic.
- 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