Drugs / Factor XIII Concentrate
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT00945906 | Sep 2009 → Aug 2011 | congenital factor XIII deficiency | CSL Behring | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2014-02-28 | CSL Behring | Regulatory CSL Behring Receives FDA Approval to Expand the Indication for Corifact® csl.com ↗ |
| 2011-02-18 | CSL Behring | Regulatory CSL Behring Receives FDA Approval of Corifact™ for Treatment of Congenital Factor XIII Deficiency csl.com ↗
18 Feb 2011 CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Corifact™, Factor XIII Concentrate (Human), for the routine prophylactic treatment of congenital factor XIII (FXIII) deficiency. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2014-02-28 | CSL Behring | CSL Behring Receives FDA Approval to Expand the Indication for Corifact® csl.com ↗ |
| 2011-02-18 | CSL Behring | CSL Behring Receives FDA Approval of Corifact™ for Treatment of Congenital Factor XIII Deficiency csl.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Factor XIII Concentrate | “Factor XIII Concentrate is given to patients whose blood is lacking factor XIII.” NCT00945906 ↗ |
| Known as | FXIII Concentrate (Human) | “In this study, patients will be treated with FXIII Concentrate (Human) and followed closely to determine that they receive the dose of FXIII Concentrate (Human) that will best...” NCT00945906 ↗ |
| Action | Restore | “Factor XIII Concentrate is given to patients whose blood is lacking factor XIII.” NCT00945906 ↗ |
| Modality | Protein / enzyme biologic | “Human Plasma-Derived Factor XIII Concentrate” NCT00945906 ↗ |
| Route | Intravenous | “by intravenous (IV) infusion” NCT00945906 ↗ |