A Prospective, Multicenter, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Human Plasma-derived Fibrinogen Concentrate (FIB Grifols) in Subjects With Congenital Afibrinogenaemia and Severe Hypofibrinogenemia Requiring Either On-demand Treatment for Acute Bleeding or Surgical Prophylaxis
Latest Information Update: 26 Oct 2023
At a glance
- Drugs Fibrinogen (Primary)
- Indications Afibrinogenaemia
- Focus Registrational; Therapeutic Use
- Sponsors Grifols
Most Recent Events
- 18 Oct 2023 Status changed from suspended to withdrawn prior to enrolment.
- 03 Jul 2023 The trial has been completed in Bulgaria (End Date: 12 Jan 2023), according to European Clinical Trials Database record.
- 21 Sep 2022 Planned End Date changed from 31 Dec 2023 to 1 Mar 2025.