Trial Profile
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
Status:
Completed
Phase of Trial:
Phase II
Latest Information Update: 20 Jan 2022
Price :
$35
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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.