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

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

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 13 Jun 2017

At a glance

  • Drugs Fibrinogen (Primary)
  • Indications Afibrinogenaemia; Congenital disorders; Haemorrhage
  • Focus First in man; Pharmacokinetics
  • Sponsors Biotest AG
  • Most Recent Events

    • 12 Jun 2016 This trial is discontinued in Italy as per European Clinical Trials Database record.
    • 02 Jun 2016 Planned number of patients changed from 20 to 35.
    • 02 Jun 2016 Planned End Date changed from 1 Oct 2016 to 1 Oct 2018.
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