Drugs / Prothrombin Complex Concentrate
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | esophageal varices with bleeding | 2012-05-29 | “FDA has accepted for standard review its Biologics License Application (BLA) for a human 4-factor prothrombin complex concentrate (PCC)” csl.com ↗ |
Trials 17
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02561923 | Aug 2015 → Jun 2016 | — | Janssen Scientific Affairs, LLC | Completed | No outcome recorded |
| Phase 1 | NCT00770718 | Apr 2008 → Apr 2010 | intracerebral hemorrhage | University of Utah | Terminated | No outcome recorded Stop: Enrollment |
| Phase 24 trials | ||||||
| Phase 2 | NCT04019015 | Mar 2021 → Dec 2024 | — | Oregon Health and Science University | Unknown | No outcome recorded |
| Phase 2 | NCT04434001 | Feb 2020 → May 2021 | acquired coagulation factor deficiency, acute lung injury, congenital heart disease, hemorrhagic disease | IRCCS Policlinico S. Donato | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03981484 | Jan 2020 → Oct 2022 | blood coagulation disease, hemorrhagic disease | Bellal A. Joseph, MD, FACS | Unknown | No outcome recorded |
| Phase 2 | NCT03715348 | Mar 2019 → Jan 2020 | hemorrhagic disease | Queen Mary University of London | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT03341156 | Jul 2018 → Sep 2020 | advanced heart failure, congestive heart failure | University of Maryland, Baltimore | Terminated | No outcome recorded Stop: Enrollment |
| Phase 49 trials · 1 missed | ||||||
| Phase 4 | NCT06144125 | Mar → Sep 2026 overdue | heart valve disorder | Konkuk University Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT07406139 | Mar → Dec 2026 expected | hemophilia | Institute of Hematology & Blood Diseases Hospital, China | Recruiting | No outcome recorded |
| Phase 4 | NCT06144112 | Sep 2025 → Mar 2026 overdue | liver disorder | Konkuk University Medical Center | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06144099 | Mar 2024 → Apr 2025 | osteoarthritis, hip, prostate cancer | Konkuk University Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT04244981 | Oct 2023 → Mar 2025 | cardiac valvular defect | SHI Jia | Terminated | No outcome recorded |
| Phase 4 | NCT02557672 | Aug 2016 → Jun 2021 | hemorrhagic disease | Mayo Clinic | Completed | Missed primary |
| Phase 4 | NCT02777424 | Jan 2016 → Mar 2019 | intracerebral hemorrhage | Fondation Ophtalmologique Adolphe de Rothschild | Completed | No outcome recorded |
| Phase 4 | NCT01159210 | Jul 2010 → Apr 2012 | coagulation protein disease | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 4 | NCT00928915 | Jul 2009 → Jan 2015 | intracerebral hemorrhage | Heidelberg University | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07857434 | Oct 2026 → Nov 2028 expected | liver disorder | Third Affiliated Hospital, Sun Yat-Sen University | Not yet recruiting | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 1 | NCT02270918 Comparator | Nov → Dec 2014 | thrombotic disease | Thomas Jefferson University | Completed | No outcome recorded |
| Phase 2 | NCT04114643 Comparator | Sep 2019 → Jul 2020 | — | University Health Network, Toronto | Unknown | No outcome recorded |
| Phase 3 | NCT01545635 Comparator | Mar 2012 → Feb 2016 | brain injury | Medical University Innsbruck | Terminated | No outcome recorded |
| Phase 4 | NCT05667805 Comparator | Jan 2023 → Jan 2027 expected | cirrhosis of liver | Medical University of Vienna | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 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) |
| 2015-09-08 | CSL Behring | Regulatory Centers for Medicare and Medicaid Services Extends New Technology Add-On Payment for CSL Behring’s Kcentra® for Third Year csl.com ↗
08 Sep 2015 CSL Behring today announced that the Centers for Medicare and Medicaid Services (CMS) again extended the new technology add-on payment (NTAP) for Kcentra® (Prothrombin Complex Concentrate [Human]). |
| 2015-03-17 | CSL Behring | Results The Lancet Publishes CSL Behring’s Kcentra® Phase III Data csl.com ↗
Results of the multicenter, open-label, phase IIIb randomized trial showed that in 168 evaluable patients, 90 percent of patients treated with Kcentra achieved effective hemostasis, compared to 75 percent of patients treated with plasma. |
| 2014-12-01 | CSL Behring | Regulatory CMS Extends New Technology Add-On Payment for CSL Behring’s Kcentra® csl.com ↗
CSL Behring today announced that the Centers for Medicare and Medicaid Services (CMS) has extended the new technology add-on payment (NTAP) for Kcentra ® (Prothrombin Complex Concentrate [Human]) through September 2015 for eligible Medicare beneficiaries treated in the inpatient hospital setting. |
| 2013-12-09 | CSL Behring | Results CSL Behring Study Shows Kcentra® Superior to Plasma for Warfarin Reversal in Patients Requiring an Urgent Surgical Procedure csl.com ↗
“The data demonstrated a strong benefit for Kcentra over plasma for patients on VKAs requiring an urgent surgery or invasive procedure,” said Majed Refaai, M.D., Associate Professor, Department of Pathology and Laboratory Medicine, University of Rochester Medical Center. |
| 2013-08-12 | CSL Behring | Regulatory CMS Approves New Technology Add-On Payment for CSL Behring’s Kcentra™ csl.com ↗
12 Aug 2013 CSL Behring today announced that the Centers for Medicare and Medicaid Services (CMS) has approved a new technology add-on payment (NTAP) for Kcentra™ (Prothrombin Complex Concentrate [Human]) for use in the inpatient hospital setting for the urgent reversal of warfarin therapy in adult patients with acute major bleeding. |
| 2013-04-29 | CSL Behring | Regulatory CSL Behring Receives FDA Approval of Kcentra™ for Urgent Warfarin Reversal in Patients with Acute Major Bleeding csl.com ↗
the U.S. Food and Drug Administration (FDA) approved Kcentra™ |
| 2012-05-29 | CSL Behring | Regulatory CSL Behring Announces FDA Filing of Biologics License Application for 4-Factor PCC for Urgent Reversal of Vitamin K Antagonist Anticoagulant Therapy csl.com ↗ |
All press releases naming this drug 10 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | prothrombin complex concentrate | “prothrombin complex concentrate (PCC) in the treatment of bleeding episodes” NCT07406139 ↗ |
| Known as | Kcentra | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02270918 ↗ |
| Known as | Octaplex 500 iu | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068614 ↗ |
| Known as | PCC | “according to the Thromboelastography (TEG) test, CK r-time prolongation,prothrombin complex concentrate (PCC) administration” NCT06144099 ↗4“Prothrombin Complex Concentrate (PCC) is thought to be a promising treatment option.” NCT03981484 ↗ “Prothrombin Complex Concentrate (PCC)” NCT00770718 ↗ “Prothrombin complex concentrate (PCC)” NCT00928915 ↗ |
| Known as | Prothrombin complex concentrate (Human) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02557672 ↗ |
| Action | Restore | “dosage and duration of replacement therapy depend on the severity of the disorder” NCT01159210 ↗ |
| Modality | Protein / enzyme biologic | “PCC (Profilnine®SD) is a mixture of the following vitamin K-dependent clotting factors” NCT00770718 ↗ |
| Route | Intravenous | “intravenously, 30 IU/kg” NCT00928915 ↗ |
| Target | F10 | “Coagulation factor X exogenous protein” CHEMBL6068614 ↗ |
| Target | F2 | “Thrombin exogenous protein” CHEMBL6068614 ↗ |
| Target | F7 | “Coagulation factor VII exogenous protein” CHEMBL6068614 ↗ |
| Target | F9 | “Coagulation factor IX exogenous protein” CHEMBL6068614 ↗ |
| Target | PROC | “Vitamin K-dependent protein C exogenous protein” CHEMBL6068614 ↗ |
| Target | PROS1 | “Vitamin K-dependent protein S exogenous protein” CHEMBL6068614 ↗ |