Prospective, Open-label, Uncontrolled, Phase III Study to Assess the Efficacy, Safety and Pharmacokinetic of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery in Paediatric Subjects With Congenital Fibrinogen Deficiency
Phase of Trial: Phase III
Latest Information Update: 24 Nov 2017
At a glance
- Drugs Fibrinogen (Primary)
- Indications Afibrinogenaemia
- Focus Therapeutic Use
- Sponsors Octapharma
- 04 May 2016 Status changed from not yet recruiting to recruiting.
- 14 Oct 2015 Planned initiation date changed from 1 Aug 2015 to 1 Dec 2015, as reported by ClinicalTrials.gov.
- 08 Apr 2015 New trial record