Trial Profile
A Phase III Open, Multicentre Study to Investigate the Pharmacokinetics, Safety and Efficacy of BPL's High Purity Factor X in the Treatment of Severe and Moderate Factor X Deficiency.
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 07 Nov 2021
Price :
$35
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At a glance
- Drugs Factor X (Primary)
- Indications Factor X deficiency
- Focus Pharmacokinetics; Registrational
- Sponsors Bio Products Laboratory
- 30 Mar 2016 Results published in Bio Products media release.
- 30 Mar 2016 According to Bio Products media release, European Medicines Agency has granted marketing authorisation for Coagadex.
- 21 Oct 2015 According to a Bio Products Laboratory media release, the US FDA had approved Coagadex for the treatment of adults and children (aged 12 years and over) with hereditary factor X deficiency.