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: 15 Mar 2018

At a glance

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

    • 15 Mar 2018 According to a Biotest AG media release, the results of this and another study (700288385) will serve as a basis for the marketing authorisation of fibrinogen concentrate BT524 for treatment of patients with congenital and acquired fibrinogen deficiency.
    • 15 Mar 2018 According to a Biotest AG media release, based on the first preliminary results, the EMA has agreed on the paediatric investigation plan for treatment of children below 6 years in this study.
    • 12 Jun 2016 This trial is discontinued in Italy as per European Clinical Trials Database record.
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