Drugs / EVICEL

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Evicel — 2008-10-05 europa.eu ↗

Trials 6

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2/31 trial
Phase 2/3 NCT01174992 Jul 2010 → Sep 2011 craniofacial and skeletal defects Ethicon, Inc. Completed No outcome recorded
Phase 33 trials · 1 met primary
Phase 3 NCT02309645 Oct 2014 → Aug 2021 cerebrospinal fluid leak Ethicon, Inc. Terminated No outcome recorded Stop: Enrollment
Phase 3 NCT02227706 Aug 2014 → Apr 2019 hemorrhagic disease Ethicon, Inc. Completed No outcome recorded
Phase 3 NCT00154141 Jun 2005 → Mar 2006 peripheral vascular disease Ethicon, Inc. Completed Met primary
Phase not applicable2 trials · 1 missed
— NCT01816282 Mar 2011 → Apr 2012 osteoarthritis, knee University of Milan Completed Missed primary
— NCT01226914 Jun 2010 → Jul 2014 goiter, thyroid tumor Medical University of South Carolina Completed No outcome recorded
Comparator or background therapy3 trials
Phase 3 NCT03461406 Comparator Jan 2019 → Apr 2022 — Grifols, S.A. Completed Met primary
Phase 3 NCT02553122 Comparator Oct 2015 → Oct 2016 osteoarthritis, knee Montefiore Medical Center Withdrawn No outcome recorded
Phase 4 NCT01235715 Comparator Sep 2010 → Mar 2012 osteoarthritis Hospital for Special Surgery, New York Completed No outcome recorded

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 9 sources stand behind the page.

FieldValueCited text
Known as EVICEL “This study evaluated the safety and haemostatic effectiveness of a fibrin sealant (EVICEL(™) Fibrin Sealant (Human)) during vascular surgery.” PMID 20730858 ↗ Aug 2010
8

NCT03461406 ↗

NCT01235715 ↗

NCT01174992 ↗

NCT01816282 ↗

NCT01226914 ↗

NCT02309645 ↗

NCT02553122 ↗

NCT02227706 ↗

Modality Protein / enzyme biologic “EVICEL is a human plasma derived fibrin sealant” NCT01174992 ↗
Route Other “aerosolized using a pedal-controlled inert gas supply” NCT01226914 ↗