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Kcentra
Kcentra is a Small molecule drug developed by University of Maryland, Baltimore. It is currently FDA-approved. Also known as: prothrombin complex concentrate, Prothrombin Complex Concentrate (Human), Beriplex, 4 factor prothrombin complex concentrate.
Kcentra is a 4-factor prothrombin complex concentrate used to treat and prevent bleeding in certain conditions, including hemorrhagic shock and trauma injury. It contains coagulation factors II, IX, X, and VII, and is classified as an exogenous protein.
At a glance
| Generic name | Kcentra |
|---|---|
| Also known as | prothrombin complex concentrate, Prothrombin Complex Concentrate (Human), Beriplex, 4 factor prothrombin complex concentrate |
| Sponsor | University of Maryland, Baltimore |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study ) (PHASE3)
- Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery (PHASE4)
- Post Marketing Observational Study on Safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure
- Administration of Prothrombin Complex Concentrate vs. Standard Transfusion During/After Heart Transplantation (PHASE3)
- A Study to Assess the Independent Effects of 4-Factor Prothrombin Complex Concentrate and Tranexamic Acid on Bleeding/Pharmacodynamics in Healthy Participants (PHASE1)
- Prehospital Kcentra for Hemorrhagic Shock (PHASE2)
- Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcentra) for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk. (PHASE3)
- PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Kcentra CI brief — competitive landscape report
- Kcentra updates RSS · CI watch RSS
- University of Maryland, Baltimore portfolio CI
Frequently asked questions about Kcentra
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Related
- Manufacturer: University of Maryland, Baltimore — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: prothrombin complex concentrate, Prothrombin Complex Concentrate (Human), Beriplex, 4 factor prothrombin complex concentrate
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing