A Prospective, Controlled, Randomised, Cross-over Study Investigating the Pharmacokinetic Properties, Surrogate Efficacy and Safety of Octafibrin Compared to Haemocomplettan.Riastap in Subjects With Congenital Fibrinogen Deficiency
Phase of Trial: Phase II
Latest Information Update: 03 Jul 2019
Price : $35 *
At a glance
- Drugs Fibrinogen (Primary)
- Indications Afibrinogenaemia
- Focus Pharmacokinetics; Therapeutic Use
- Sponsors Octapharma
- 04 Dec 2018 Results assessing the efficacy and PK of Fibryga in Treating Acute Bleeding in Adolescent Patients with Congenital Fibrinogen Deficiency using data from FORMA-01 and FORMA-02 studies, presented at the 60th Annual Meeting and Exposition of the American Society of Hematology
- 08 Dec 2017 Primary endpoint of fibrinogen activity normalized area under the curve standardized (AUCnorm) has not been met according to results published in the Journal of Thrombosis and Haemostasis.
- 08 Dec 2017 Primary endpoint of maximum clot firmness at 1 hr Post Infusion has not been met, according to results published in the Journal of Thrombosis and Haemostasis.