Drugs / Prothrombin Complex Concentrate
Prothrombin Complex Concentrate
also known as
PCC · 4F-PCC · Kcentra · Prothrombin complex concentrate (Human) · 4-Factor Prothrombin Complex Concentrate · Beriplex · four factor prothrombin complex concentrate · Confidex · +1 more
Protein / enzyme biologic targets F10, F2, F7, F9, PROC, PROS1
Trials 22 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT04543383 | Jul 2020 → Jun 2023 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| 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 |
| Phase 25 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 |
| 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 2 | NCT02463591 | Jan 2015 → Jul 2016 | — | University Medical Center Groningen | Unknown | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT03341156 | Jul 2018 → Sep 2020 | advanced heart failure, congestive heart failure | University of Maryland, Baltimore | Terminated | No outcome recorded |
| Phase 3 | NCT00803101 | Feb 2009 → Nov 2012 | — | CSL Behring | Completed | No outcome recorded |
| Phase 411 trials | ||||||
| Phase 4 | NCT06144125 | Mar → Sep 2026 expected | 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 | NCT03473132 | Mar 2018 → Dec 2021 | — | Brigham and Women's Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT03064035 | Apr 2017 → Apr 2019 | hemorrhagic disease | HealthPartners Institute | Completed | No outcome recorded |
| Phase 4 | NCT02557672 | Aug 2016 → Jun 2021 | hemorrhagic disease | Mayo Clinic | Completed | No outcome recorded |
| 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 | ||||||
| — | NCT02429453 | Apr 2015 → Mar 2016 | brain injury, intracerebral hemorrhage | University of Utah | Withdrawn | No outcome recorded |
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02270918 Comparator | Nov → Dec 2014 | thrombotic disease | Thomas Jefferson University | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT04114643 Comparator | Sep 2019 → Jul 2020 | — | University Health Network, Toronto | Unknown | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT01545635 Comparator | Mar 2012 → Feb 2016 | brain injury | Medical University Innsbruck | Terminated | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT05667805 Comparator | Jan 2023 → Jan 2027 expected | cirrhosis of liver | Medical University of Vienna | Recruiting | No outcome recorded |
Press releases naming this drug 7 releases
| Date | Issuer | Release |
|---|---|---|
| 2015-09-08 | CSL Behring | Centers for Medicare and Medicaid Services Extends New Technology Add-On Payment for CSL Behring’s Kcentra® for Third Year csl.com ↗ |
| 2015-03-17 | CSL Behring | The Lancet Publishes CSL Behring’s Kcentra® Phase III Data csl.com ↗ |
| 2014-12-01 | CSL Behring | CMS Extends New Technology Add-On Payment for CSL Behring’s Kcentra® csl.com ↗ |
| 2013-12-09 | CSL Behring | CSL Behring Study Shows Kcentra® Superior to Plasma for Warfarin Reversal in Patients Requiring an Urgent Surgical Procedure csl.com ↗ |
| 2013-08-12 | CSL Behring | CMS Approves New Technology Add-On Payment for CSL Behring’s Kcentra™ csl.com ↗ |
| 2013-04-29 | CSL Behring | CSL Behring Receives FDA Approval of Kcentra™ for Urgent Warfarin Reversal in Patients with Acute Major Bleeding csl.com ↗ |
| 2012-07-06 | CSL Behring | CSL Behring Launches New Beriplex® P/N Dosing Calculator App for Healthcare Professionals on the Move csl.com ↗ |
Evidence & citations 19 cited values
Every value below carries the sentence it was read from. 30 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 | 4-Factor Prothrombin Complex Concentrate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04543383 ↗ |
| Known as | 4F-PCC | “Four-factor prothrombin complex concentrate (4F-PCC) can temporarily restore hemostasis in patients undergoing anticoagulation with warfarin.” PMID 38521486 ↗ Mar 20242“4-Factor Prothrombin Complex Concentrate (4F-PCC)” NCT04543383 ↗ “4-factor prothrombin complex concentrate (4FPCC)” NCT03064035 ↗ |
| Known as | Beriplex | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02463591 ↗ |
| Known as | Confidex | “vitamin K concomitant with a single dose of either 4F-PCC (Beriplex/Kcentra/Confidex; CSL Behring, Marburg, Germany) or plasma” PMID 25728933 ↗ Feb 2015 |
| Known as | four factor prothrombin complex concentrate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03473132 ↗ |
| 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 | “restoration of vitamin K-dependent factors” PMID 41910938 ↗ Mar 2026 |
| Modality | Protein / enzyme biologic | “PCC (Profilnine®SD) is a mixture of the following vitamin K-dependent clotting factors” NCT00770718 ↗ |
| Route | Intravenous | “Intravenous infusion” NCT00803101 ↗ |
| 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 ↗ |