Drugs / Fibrinogen

Trials 11

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT02281500 Jul 2016 → Nov 2019 congenital afibrinogenemia Grifols Therapeutics LLC Completed No outcome recorded
Phase 21 trial
Phase 2 NCT00968045 Apr 2009 → Feb 2012 coronary artery disorder, hemorrhagic disease Sahlgrenska University Hospital Completed No outcome recorded
Phase 2/31 trial · 1 missed
Phase 2/3 NCT01359878 May 2011 → May 2013 — Copenhagen University Hospital at Herlev Completed Missed primary
Phase 33 trials · 1 missed
Phase 3 NCT05300672 Feb 2022 → Dec 2024 intracerebral hemorrhage, ischemic stroke Azienda Usl di Bologna Completed No outcome recorded
Phase 3 NCT01662856 Aug 2012 → Dec 2015 vascular hemostatic disease Grifols, S.A. Completed No outcome recorded
Phase 3 NCT01539057 Jul 2012 → Sep 2013 esophageal varices with bleeding Hospital Universitari de Bellvitge Unknown Missed primary
Phase 44 trials
Phase 4 NCT05391412 Jun 2022 → Jul 2023 disseminated intravascular coagulation, hemorrhagic disease, scoliosis Brno University Hospital Unknown No outcome recorded
Phase 4 NCT04376762 Oct 2021 → Mar 2023 hemorrhagic disease, juvenile Huntington disease University of Virginia Completed No outcome recorded
Phase 4 NCT04405518 Jun 2019 → Nov 2021 fibrinolytic defect Antoni Sabaté Pes Unknown No outcome recorded
Phase 4 NCT02299947 Aug 2014 → Apr 2018 hemorrhagic disease, thoracic aortic aneurysm St. Antonius Hospital Terminated No outcome recorded
Phase not applicable1 trial
— NCT00713596 Jul 2008 → Jan 2010 — Mayo Clinic Terminated No outcome recorded
Comparator or background therapy5 trials
Phase 1/2 NCT02203968 Comparator Oct 2014 → Dec 2015 blood coagulation disease, hemorrhagic disease Sunnybrook Health Sciences Centre Completed No outcome recorded
Phase 1/2 NCT00493272 Comparator Jun 2007 → Apr 2008 blood coagulation disease Christian Fenger-Eriksen Completed No outcome recorded
Phase 2 NCT02344069 Comparator Feb 2015 → Mar 2017 hemorrhagic disease Rigshospitalet, Denmark Completed No outcome recorded
Phase 3 NCT01623531 Comparator Feb 2014 → Mar 2019 cardiac valvular defect Nova Scotia Health Authority Completed No outcome recorded
Phase 3 NCT01471730 Comparator Nov 2011 → Dec 2014 heart disorder IRCCS Policlinico S. Donato Completed No outcome recorded

Press releases naming this drug 12 releases

DateIssuerRelease
2026-06-15 Grifols Therapeutics LLC Grifols launches FESILTY™ (fibrinogen, human-chmt) in the U.S. grifols.com ↗
2025-12-19 Grifols Therapeutics LLC Grifols receives US FDA approval for new fibrinogen concentrate, FESILTYTM (fibrinogen, human-chmt) grifols.com ↗
2025-01-09 Grifols Therapeutics LLC Grifols submits Biologics License Application for its new fibrinogen solution to U.S. FDA grifols.com ↗
2024-08-09 Octapharma FDA approves fibryga® for acquired fibrinogen deficiency, potentially ushering in a new standard of care octapharma.com ↗
2024-02-14 Grifols Therapeutics LLC Grifols announces positive topline phase 3 fibrinogen clinical trial results grifols.com ↗
2020-08-14 Octapharma Octapharma’s Fibryga® receives Health Canada approval to treat acquired fibrinogen deficiency (AFD) in surgical settings octapharma.com ↗
2020-01-21 Octapharma Positive results for fibryga® in the treatment of bleeding and surgical prophylaxis in patients with congenital fibrinogen deficiency (FORMA-02) published in the Journal of Thrombosis and Haemostasis octapharma.com ↗
2019-11-05 Octapharma Octapharma’s fibryga® receives European label extension to treat acquired fibrinogen deficiency (AFD) octapharma.com ↗
2019-10-31 Octapharma Octapharma announces publication of data on fibryga® for the treatment of acquired fibrinogen deficiency in patients undergoing cardiac surgery octapharma.com ↗
2012-12-19 CSL Behring Phase II Study Indicates that Fibrinogen Concentrate Given as a First-Line Therapy Safely Reduces Need for Transfusion after Aortic Surgery csl.com ↗
2009-03-11 CSL Behring CSL Behring Receives Orphan-Drug Exclusivity for RiaSTAP csl.com ↗
2009-01-16 CSL Behring CSL Behring Receives FDA Approval of RiaSTAP, First and Only Approved Treatment of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency csl.com ↗

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 17 sources stand behind the page.

FieldValueCited text
Known as fibrinogen “Combination of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).” NCT01662856 ↗
15

“single dose fibrinogen concentrate immediately after CTC leads to a decrease in the number of allogenic blood transfusions” NCT02299947 ↗

NCT02281500 ↗

NCT01359878 ↗

NCT00968045 ↗

NCT04405518 ↗

NCT02344069 ↗

NCT01539057 ↗

NCT04376762 ↗

NCT00493272 ↗

NCT02203968 ↗

Show 5 more sources

Known as Riastap “The drug used in this study is Riastap, 1g (Fibrinogen).” NCT04405518 ↗
Action Restore “Use of fibrinogen concentrate allows high-dose substitution without the need for blood type crossmatch.” PMID 22805300 ↗ Jul 2012
Modality Protein / enzyme biologic “fibrinogen concentrate” NCT00493272 ↗
Route Intravenous “2 g of fibrinogen concentrate (Haemocomplettan, CSL Behring) i.v.” NCT01359878 ↗