Trial Profile
A prospective, open-label, phase I/II study investigating pharmacokinetic properties of BT524 and efficacy and safety of BT524 in the treatment and prophylaxis of bleeding in patients with congenital fibrinogen deficiency
Status:
Completed
Phase of Trial:
Phase I/II
Latest Information Update: 01 Aug 2022
Price :
$35
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At a glance
- Drugs Fibrinogen (Primary)
- Indications Afibrinogenaemia; Congenital disorders; Haemorrhage
- Focus First in man; Pharmacokinetics; Registrational
- Sponsors Biotest AG
- 01 Aug 2022 Protocol amended to Terminal Elimination Half-life (t1/2) for Fibrinogen Antigen, Time to Maximum Concentration (Tmax) for Fibrinogen Antigen, Maximum Concentration (Cmax) for Fibrinogen Antigen, Area Under the Curve (AUC) Calculated to the Last Measured Concentration (AUC0-tz) for Fibrinogen Antigen, Extent of Area Under the Curve (AUC) Extrapolation Beyond Last Concentration (AUCextr) for Fibrinogen Antigen, Area Under the Curve (AUC) From Time 0 to Infinity (AUC0) for Fibrinogen Antigen
- 25 Jul 2022 Status changed from recruiting to completed.
- 12 Aug 2020 This trial has been completed in Bulgaria, according to European Clinical Trials Database record.