Octafibrin

BIOLOGICAL4 trials

Sponsors

Octapharma, University Health Network, Toronto

Conditions

AfibrinogenemiaCongenital Fibrinogen DeficiencyDeficiency; Fibrinogen, Acquired

Phase 2

Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap

CompletedNCT01575756

OctapharmaAfibrinogenemia, Congenital Fibrinogen Deficiency

Start: 2013-06-30End: 2015-01-31Updated: 2018-03-09

Phase 3

Efficacy and Safety Study of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery

CompletedNCT02267226

OctapharmaCongenital Fibrinogen Deficiency

Start: 2014-09-30End: 2018-02-14Updated: 2021-01-15

Study to Assess the Efficacy, Safety and Pharmacokinetic of Octafibrin in Paediatric Subjects With Fibrinogen Deficiency

CompletedNCT02408484

OctapharmaCongenital Fibrinogen Deficiency

Start: 2015-12-31End: 2019-06-11Updated: 2021-01-15

FIBrinogen REplenishment in Surgery

CompletedNCT03037424

University Health Network, TorontoDeficiency; Fibrinogen, Acquired

Start: 2017-02-22End: 2019-03-27Updated: 2019-05-14

Related Papers

Fibrinogen concentrate versus cryoprecipitate for bleeding in cardiac surgery patients stratified by surgery risk in the phase 3 fibres Study

Blood2025-11-03

Impact of cardiopulmonary bypass duration on efficacy of fibrinogen replacement with cryoprecipitate compared with fibrinogen concentrate: a post hoc analysis of the Fibrinogen Replenishment in Surgery (FIBRES) randomised controlled trial

British Journal of Anaesthesia2022-06-2813 citations

Weight-adjusted dosing of fibrinogen concentrate and cryoprecipitate in the treatment of hypofibrinogenaemic bleeding adult cardiac surgical patients: a <i>post hoc</i> analysis of the Fibrinogen Replenishment in cardiac surgery randomised controlled trial.

2022-06-09

Effect of Fibrinogen Concentrate vs Cryoprecipitate on Blood Component Transfusion After Cardiac Surgery

JAMA2019-10-21158 citations

Fibrinogen Concentrate Vs. Cryoprecipitate for Acquired Hypofibrinogenemia in Cardiac Surgery — the FIBRES Study

Blood2018-11-29

Protocol for a phase III, non-inferiority, randomised comparison of a new fibrinogen concentrate versus cryoprecipitate for treating acquired hypofibrinogenaemia in bleeding cardiac surgical patients: the FIBRES trial

BMJ Open2018-04-0123 citations

Efficacy and safety of a new human fibrinogen concentrate in patients with congenital fibrinogen deficiency: an interim analysis of a Phase III trial.

2017-11-3013 citations