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: 20 Jun 2019
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At a glance
- Drugs Turoctocog alfa pegol (Primary)
- Indications Haemophilia A
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms PATHFINDER 2
- Sponsors Novo Nordisk
- 20 Jun 2019 According to a Novo Nordisk media release, the European Commission has granted marketing authorisation for Esperoct for the treatment of adolescents (=12 years of age) and adults with haemophilia A.
- 16 May 2019 This trial has been completed in Netherland as per European Clinical Trials Database record.
- 26 Apr 2019 The Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency (EMA), adopted a positive opinion for the use of Esperoct (turoctocog alfa pegol, N8-GP) recommending marketing authorisation for the treatment of adolescents and adults with haemophilia A, based on the results from this study.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History