Drugs / ARTISS
ARTISS
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT01684020 | Nov 2012 → Apr 2016 | — | DeNova Research | Completed | No outcome recorded |
| Phase 2 | NCT00708071 | Jun → Sep 2008 | — | Baxter Healthcare Corporation | Completed | Missed primary |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT00157131 | Jun 2004 → Feb 2007 | — | Baxter Healthcare Corporation | Completed | Met primary |
| Phase 41 trial · 1 met primary | ||||||
| Phase 4 | NCT03305757 | Jun 2014 → Aug 2019 | breast cancer | Zuyderland Medical Center | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT04931615 Comparator | Feb 2022 → Feb 2023 | breast neoplasm | Mid and South Essex NHS Foundation Trust | Completed | No outcome recorded |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ARTISS | “Exploratory, randomized, controlled, phase 2 study to evaluate the safety and efficacy of adjuvant fibrin sealant VH S/D 4 S-Apr (ARTISS) in patients undergoing rhytidectomy.” PMID 23515377 ↗ Mar 2013 |
| Known as | FS 4IU VH S/D | “FS 4IU VH S/D [FS 4IU VH S/D will be marketed under the trade name ARTISS upon licensure in the United States]” PMID 18354285 ↗ Mar 2008 |
| Known as | FS VH S/D 4 S-Apr | “The authors evaluate the safety and preliminary efficacy of the fibrin sealant (FS) VH S/D 4 s-apr (ARTISS; Baxter Healthcare Corp, Deerfield, Illinois), added to...” PMID 23515377 ↗ Mar 2013 |
| Modality | Protein / enzyme biologic | “a two-component fibrin sealant with 4 IU/mL human thrombin” NCT00157131 ↗ |
| Route | Topical | “Administration by a topical spray application using the TISSOMAT device and Spray Set.” NCT00157131 ↗ |