factor xiii concentrate (human)
Trade name: Corifact
BiologicalapprovedOrphan Drug FDA
Approved
Feb 17, 2011
Factor XIII, or fibrin stabilizing factor, is a plasma protein and zymogen. It is activated by thrombin to factor XIIIa which crosslinks fibrin in coagulation. Deficiency of XIII worsens clot stability and increases bleeding tendency. — Wikipedia
Clinical trial activity
7 trials · 12 clinical orgs · 1 marketing orgs
Phase 1
0
Phase 2
5
Phase 3
3
Phase 4
1
Earliest trial started Jan 1, 2000 (NCT00640289)
Timeline
1980s
- Jan 16, 1985
Orphan Drug Designation
2000s
- Jan 1, 2009
CSL Behring — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2009
CSL Behring — Earliest Phase 3 Sponsor(trial)
2010s
- Feb 15, 2011
CSL Behring — First NDA Organization
- Feb 15, 2011
CSL Behring — NDA Organization
- Feb 17, 2011
Earliest FDA Approval
Indications
Approved for
Mechanism of action
- Coagulation factor XIIIAGONIST
F13A1 agonist
Approval history
- approvedAcceleratedFeb 17, 2011
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaFactor XIII ↗
- NCATSF7R0FBC1XD ↗
Also known as
- coagulation factor xiii
- coagulation factor xiii
- corifact
- corifact
- factor xiii
- factor xiii
- factor xiii concentrate (human)
- factor xiii concentrate (human)
- factor xiii concentrate (human)
- factor xiii (fibrin stabilising factor)
- factor xiii (human)
- factor xiii, human
- fibrinoligase
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06481995 | Phase 4 | Jul 9, 2024 | Cantonal Hospital of St. Gallen, Cantonal Hospital Winterthur, Kantonsspital Baden, Spital Zollikerberg, University of Basel, University of Geneva, University of Lausanne, University of Zurich |
| NCT02551042 | Phase 2 | Sep 1, 2015 | CSL Behring, University of London |
| NCT01545635 | Phase 3 | Mar 1, 2012 | Medical University Innsbruck |
| NCT00945906 | Phase 3 | Sep 1, 2009 | CSL Behring |
| NCT00885742 | Phase 3 | Aug 1, 2009 | CSL Behring |
| NCT00883090 | Phase 2 | May 1, 2009 | CSL Behring |
| NCT00640289 | N/A | Jan 1, 2000 | CSL Behring, University of California, Irvine |
Showing 7 of 7 trials
Page 1 / 1
Organizations
Research & Development (12)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| CSL Behring | For profit | 5 | 3 | 3 | 2000 |
| Cantonal Hospital of St. Gallen | Academic/Hospital | 1 | 0 | 1 | 2024 |
| Cantonal Hospital Winterthur | Academic/Hospital | 1 | 0 | 1 | 2024 |
| Kantonsspital Baden | Academic/Hospital | 1 | 0 | 1 | 2024 |
| Medical University Innsbruck | Academic/Hospital | 1 | 1 | 1 | 2012 |
| Spital Zollikerberg | Academic/Hospital | 1 | 0 | 1 | 2024 |
| University of Basel | Academic/Hospital | 1 | 0 | 1 | 2024 |
| University of California, Irvine | Academic/Hospital | 1 | 1 | 1 | 2000 |
| University of Geneva | Academic/Hospital | 1 | 0 | 1 | 2024 |
| University of Lausanne | Academic/Hospital | 1 | 0 | 1 | 2024 |
| University of London | Academic/Hospital | 1 | 1 | 1 | 2015 |
| University of Zurich | Academic/Hospital | 1 | 1 | 1 | 2024 |
12 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| CSL Behring | For profit | NDA | Feb 15, 2011 |