A Multi-national Trial Evaluating Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Patients With Haemophilia A
Phase of Trial: Phase III
Latest Information Update: 27 Feb 2018
At a glance
- Drugs Turoctocog alfa pegol (Primary)
- Indications Haemophilia A
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms PATHFINDER 2
- Sponsors Novo Nordisk
- 27 Feb 2018 According to a Novo Nordisk media release, the Company has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for N8-GP. The submission was based on results from the pathfinder clinical trial programme.
- 01 Dec 2016 Primary endpoint (the incidence rate of FVIII-inhibitors greater than or equal to 0.6 BU (Bethesda Unit)) has been met, according to results of pivotal analysis published in the Thrombosis and Haemostasis journal.
- 01 Dec 2016 Primary endpoint (annualised bleeding rate in the prophylaxis arm) has been met, according to results of pivotal analysis published in the Thrombosis and Haemostasis journal.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History