human factor ix complex (prothrombin complex concentrate)
Trade name: Bebulin
BiologicalapprovedOrphan Drug FDA
Approved
Aug 21, 1970
Prothrombin is encoded in the human by the F2-gene. It is proteolytically cleaved during the clotting process by the prothrombinase enzyme complex to form thrombin. — Wikipedia
Clinical trial activity
43 trials · 43 clinical orgs · 4 marketing orgs
Phase 1
8
Phase 2
19
Phase 3
13
Phase 4
11
Earliest trial started Jul 1, 1978 (NCT00000582)
Timeline
1970s
1980s
- Jul 20, 1981
Grifols — NDA Secondary Org
2000s
- Jan 1, 2008
Earliest Phase 1 Sponsor(trial)
2010s
- Dec 27, 2012
Orphan Drug Designation
- Apr 29, 2013
CSL Behring — NDA Secondary Org
- Jan 1, 2015
Earliest Phase 2 Sponsor(trial)
Indications
Studied for
- Anticoagulants · Phase 4
- Bleeding Time · Phase 2
- Blood Coagulation · Phase 4
- Blood Coagulation Disorders · Phase 3
- Blood Loss, Surgical · Phase 4
- Blood Transfusion · Phase 2
- Bronchiectasis · Phase 4
- Cardiac Surgical Procedures · Phase 4
- Cardiovascular Surgical Procedures · Phase 4
- Deficiency Diseases · Phase 4
- Fibrin · Phase 2
- General Surgery · Phase 2
- Healthy Volunteers · Phase 1
- Heart Defects, Congenital · Phase 2
- Heart Diseases · Phase 3
- Heart Failure · Phase 3
- Heart Valve Diseases · Phase 4
- Hematologic Diseases · Phase 3
- Hemophilia A · Phase 3
- Hemorrhage · Phase 4
- Hemorrhagic Disorders · Phase 3
- Intracranial Hemorrhages · Phase 4
- Knee Injuries · Phase 4
- Liver Cirrhosis · Phase 4
- Liver Diseases · Phase 4
- Osteoarthritis, Hip · Phase 4
- Pharmacology · Phase 2
- Plasma · Phase 4
- Prostatic Neoplasms · Phase 4
- Shock, Hemorrhagic · Phase 3
- Spinal Dysraphism · Phase 4
- Thrombosis · Phase 4
- Transfusion Reaction · Phase 2
- Transfusion-Related Acute Lung Injury · Phase 2
- Traumatology · Phase 3
- Vitamin K · Phase 4
Mechanism of action
- ThrombinEXOGENOUS PROTEIN
Thrombin exogenous protein
- Coagulation factor VIIEXOGENOUS PROTEIN
Coagulation factor VII exogenous protein
- Coagulation factor IXEXOGENOUS PROTEIN
Coagulation factor IX exogenous protein
- Coagulation factor XEXOGENOUS PROTEIN
Coagulation factor X exogenous protein
- Vitamin K-dependent protein SEXOGENOUS PROTEIN
Vitamin K-dependent protein S exogenous protein
- Vitamin K-dependent protein CEXOGENOUS PROTEIN
Vitamin K-dependent protein C exogenous protein
- ThrombinACTIVATOR
F2 activator
Approval history
- approvedAug 21, 1970
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaThrombin ↗
- ChEMBLCHEMBL6068492 ↗
- ChEMBLCHEMBL2109098 ↗
- ChEMBLCHEMBL6068614 ↗
- WikipediaProthrombin complex concentrate ↗
- NCATSFW411QXD5M ↗
- NCATS8FB1K07F16 ↗
Also known as
- 4-factor prothrombin complex concentrate
- beriplex
- coagulation factor ii
- coagulation factor ii human
- coagulation factor ii (human)
- factor ii
- factor ii (prothrombin)
- factor ix complex
- factor ix complex
- factor ix complex (human)
- human coagulation factor ii
- kcentra
- kcentra
- pcc
- prothrombin
- prothrombin
- prothrombin
- prothrombin complex
- prothrombin complex concentrate
- prothrombin complex concentrate (human)
- prothrombin complex concentrate (human)
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07094087 | Phase 3 | Sep 10, 2025 | CSL Behring |
| NCT06144125 | Phase 4 | Mar 1, 2024 | Konkuk University |
| NCT06144112 | Phase 4 | Mar 1, 2024 | Konkuk University |
| NCT06144099 | Phase 4 | Mar 1, 2024 | Konkuk University |
| NCT05738642 | N/A | Mar 1, 2023 | Zhejiang University |
| NCT05568888 | Phase 3 | Feb 28, 2023 | CSL Behring |
| NCT05667805 | Phase 4 | Jan 1, 2023 | Medical University of Vienna |
| NCT06627218 | N/A | Jan 1, 2021 | Zhejiang University |
| NCT04543383 | Phase 1 | Jul 27, 2020 | Janssen Pharmaceutica NV |
| NCT04244981 | Phase 4 | Mar 1, 2020 | Chinese Academy of Medical Sciences |
| NCT04434001 | Phase 2 | Feb 27, 2020 | University of Milan |
| NCT03981484 | Phase 2 | Jan 31, 2020 | University of Arizona |
| NCT04114643 | Phase 2 | Sep 24, 2019 | University of Toronto |
| NCT04019015 | Phase 2 | Sep 1, 2019 | Oregon Health and Science University |
| NCT03715348 | Phase 2 | Mar 1, 2019 | British Heart Foundation, University of London |
| NCT03784794 | N/A | Nov 1, 2018 | Grupo Mexicano para el Estudio de la Medicina Intensiva |
| NCT03341156 | Phase 3 | Jun 20, 2018 | CSL Behring, University of Maryland, University of Pittsburgh |
| NCT03218722 | Phase 3 | Dec 29, 2017 | Grenoble Alps University, University of Grenoble |
| NCT03320603 | N/A | Oct 13, 2017 | Octapharma |
| NCT02740335 | Phase 3 | May 1, 2017 | Octapharma |
Showing 20 of 43 trials
Page 1 / 3
Organizations
Research & Development (43)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| CSL Behring | For profit | 11 | 6 | 4 | 2005 |
| Janssen Pharmaceutica NV | For profit | 3 | 1 | 1 | 2012 |
| Johnson and Johnson | For profit | 3 | 3 | 1 | 2012 |
| Konkuk University | Academic/Hospital | 3 | 3 | 1 | 2024 |
| Octapharma | For profit | 3 | 3 | 2 | 2008 |
| Bayer | For profit | 2 | 0 | 1 | 2012 |
| Bristol-Myers Squibb | For profit | 2 | 1 | 1 | 2014 |
| Thomas Jefferson University | Academic/Hospital | 2 | 1 | 2 | 1978 |
| University of Milan | Academic/Hospital | 2 | 2 | 2 | 2011 |
| University of Utah | Academic/Hospital | 2 | 2 | 2 | 2008 |
| Zhejiang University | Academic/Hospital | 2 | 2 | 1 | 2021 |
| Adolphe Rothschild Ophtalmologic Foundation | Academic/Hospital | 1 | 1 | 1 | 2016 |
| Baxalta | For profit | 1 | 1 | 1 | 2010 |
| Boehringer Ingelheim | For profit | 1 | 0 | 1 | 2015 |
| British Heart Foundation | Academic/Hospital | 1 | 0 | 1 | 2019 |
| Chinese Academy of Medical Sciences | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Daiichi Sankyo | For profit | 1 | 1 | 1 | 2013 |
| Grenoble Alps University | Academic/Hospital | 1 | 0 | 1 | 2017 |
| Grupo Mexicano para el Estudio de la Medicina Intensiva | Academic/Hospital | 1 | 1 | 1 | 2018 |
| HealthPartners Institute | Academic/Hospital | 1 | 1 | 1 | 2017 |
43 organizations
Page 1 / 3
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Armour & Company | For profit | NDA | — |
| Baxalta | For profit | NDA2 | Aug 21, 1970 |
| CSL Behring | For profit | NDA2 | Apr 29, 2013 |
| Grifols | For profit | NDA2 | Jul 20, 1981 |