Drugs / Octaplex
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 34 trials · 2 met primary | ||||||
| Phase 3 | NCT05523297 | Nov 2022 → Jun 2024 | — | Octapharma | Completed | Met primary |
| Phase 3 | NCT04867837 | Sep 2021 → Jan 2026 | — | Octapharma | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT02740335 | Jun 2017 → Feb 2022 | — | Octapharma | Completed | Met primary |
| Phase 3 | NCT00618098 | May 2008 → Mar 2012 | — | Octapharma | Completed | No outcome recorded |
| Phase 42 trials · 1 missed | ||||||
| Phase 4 | NCT04534751 | Apr 2021 → Dec 2023 | blood coagulation disease | University Health Network, Toronto | Unknown | Missed primary |
| Phase 4 | NCT01910675 | Jul 2013 → Oct 2018 | — | Helsinki University Central Hospital | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2025-03-31 | Octapharma | Results Octapharma Announces Superior Haemostatic Efficacy of Four-Factor Prothrombin Complex Concentrate over Frozen Plasma in Cardiac Surgical Bleeding octapharma.com ↗
Conducted across 12 leading hospitals in Canada and the United States, the study found that octaplex®/ Balfaxar® (4F-PCC) improved haemostatic outcomes by 17.6% over FP, without increasing thromboembolic risk—presenting a more effective alternative for managing coagulation factor deficiencies in cardiac surgical patients. |
| 2024-08-15 | Octapharma | Results Octapharma USA: JAMA Network Open Publishes Study Results Demonstrating Efficacy & Safety of Balfaxar® For Warfarin Reversal in Urgent Surgery & Invasive Procedures octapharma.com ↗ |
| 2023-07-27 | Octapharma | Regulatory Octapharma's prothrombin complex concentrate, Balfaxar®, receives FDA approval for warfarin reversal in urgent surgery & invasive procedures octapharma.com ↗
Octapharma USA today announced that Balfaxar ® (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as octaplex ® ) has received U.S. Food and Drug Administration (FDA) approval for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for urgent surgery or invasive procedures. |
| 2021-04-07 | Octapharma | Results Study suggests that 4F-PCC can be used as a substitute for frozen plasma for the treatment of bleeding during cardiac surgery octapharma.com ↗
Patients in the 4F-PCC group (N = 54) had a 44% (P < 0.001) lower exposure to allogeneic blood components than the FP group (N = 47), primarily due to a significantly lower requirement of additional FP transfusions (94% lower, P < 0.001) |
All press releases naming this drug 5 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Octaplex | “Intervention group: 4 g Fibryga and 2000 IU Octaplex will be released as part of the first and second MHP packs.” NCT04534751 ↗ |
| Known as | Balfaxar | “The primary objective is to determine whether 4F-PCC (Octaplex/Balfaxar, Octapharma) is clinically non-inferior to FP for haemostatic effectiveness.” PMID 39174056 ↗ Aug 2024 |
| Modality | Protein / enzyme biologic | “Octaplex (human prothrombin complex concentrate)” NCT00618098 ↗ |
| Route | Intravenous | “Octaplex infusions intravenously” NCT00618098 ↗ |