Drugs / Octaplas LG
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial · 1 met primary | ||||||
| Phase 1 | NCT01063595 | Dec 2009 → Jul 2010 | — | Octapharma | Completed | Met primary |
| Phase 21 trial | ||||||
| Phase 2 | NCT06381661 | May 2026 → Jun 2028 expected | infectious disease with sepsis | Assistance Publique - Hôpitaux de Paris | Not yet recruiting | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07035509 | Jul 2025 → Jul 2026 overdue | infectious disease with sepsis | Fundación Cardioinfantil Instituto de Cardiología | Not yet recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT04580563 | Oct 2020 → Dec 2022 | disseminated intravascular coagulation, infectious disease with sepsis | University Hospital, Strasbourg, France | Completed | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT03092245 Comparator | Apr 2017 → Apr 2019 | infectious disease with sepsis | Rigshospitalet, Denmark | Completed | No outcome recorded |
| Phase 4 | NCT02875236 Comparator | Sep → Nov 2016 | infectious disease with sepsis | Rigshospitalet, Denmark | Terminated | No outcome recorded |
| Phase 4 | NCT02253082 Comparator | Nov 2014 → Sep 2016 | thoracic aortic aneurysm | Rigshospitalet, Denmark | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2024-08-22 | Octapharma | Regulatory Octapharma USA Receives FDA Emergency Use Authorization for octaplasLG Powder, Allows U.S. Military Medical Providers Emergent Use in Treatment of Hemorrhage or Coagulopathy octapharma.com ↗
Octapharma USA has received U.S. Food and Drug Administration Emergency Use Authorization (EUA) for its proprietary octaplasLG Powder (blood group types A and AB). |
| 2021-03-30 | Octapharma | Regulatory FDA approvals strengthen Octapharma USA pediatric critical care product portfolio octapharma.com ↗
The supplement approvals resulted in new product labeling for Octaplas ™, Pooled Plasma (Human), Solvent/Detergent (S/D) Treated Solution for Intravenous Infusion, and fibryga® , Fibrinogen (Human) Lyophilized Powder for Reconstitution. |
All press releases naming this drug 2 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | OctaplasLG | “Octaplas LG is a medication approved for use in Colombia.” NCT07035509 ↗ |
| Known as | Pharmaceutical fresh frozen plasma | “Pharmaceutical fresh frozen plasma (OCTAPLAS LG®), bolus dose of 10 mL/kg (max. 500 mL) administered over \<15 minutes” NCT07035509 ↗ |
| Action | Restore | “Supplementing the intense deficit of coagulation factors with plasma containing non-activated coagulation factors is therefore a rational therapy in DIC patients.” NCT04580563 ↗ |
| Modality | Other / unclassified | “Octaplas LG was composed of human coagulation-active plasma” NCT01063595 ↗ |
| Route | Intravenous | “Participants received 1200 mL of Octaplas LG intravenously once.” NCT01063595 ↗ |