Prothrombin complex concentrate
Highest phase reached
Phase 3
Drug type
Protein
- Listing at source
- Listed
- Highest phase reached
- Phase 3
- Drug type
- Protein
- Drug name
- Prothrombin complex concentrate
- a nonactivated complex of coagulation factors ii vii ix and x and proteins c and s for reversing the effects of vitamin k antagonist therapy
- A nonactivated complex of coagulation factors II, VII, IX, and X and proteins C and S for reversing the effects of vitamin K antagonist therapy
- BE1116 (Prothrombin Complex Concentrate)
- be1116 prothrombin complex concentrate
- kcentra
- Kcentra
- Kcentra®
- Octaplex
- Octaplex (human prothrombin complex concentrate)
- octaplex 500 iu
- Octaplex 500 iu
- Prothrombin complex
- prothrombin complex concentrate
- Prothrombin complex concentrate
- Prothrombin Complex Concentrate
- Prothrombin Complex Concentrate (PCC)
- Prothrombin Complex Concentrates
- CAS registry numbers
- 1715897-99-6
- ChEMBL ID
- CHEMBL6068614
- RxNorm IDs (RxCUI)
- 1670383
- FDA ingredient codes (UNII)
- RZ22DI43TP
- Patents
- 0
- Designations
- 1
- Earliest recorded loss of exclusivity
- 13 Dec 2020
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Mechanism
- Coagulation factor IX exogenous protein
- Action type
- EXOGENOUS_PROTEIN
- Target
- Coagulation factor IX
- Protein identifier
- P00740
- Mechanism
- Coagulation factor VII exogenous protein
- Action type
- EXOGENOUS_PROTEIN
- Target
- Coagulation factor VII
- Protein identifier
- P08709
- Mechanism
- Coagulation factor X exogenous protein
- Action type
- EXOGENOUS_PROTEIN
- Target
- Coagulation factor X
- Protein identifier
- P00742
- Mechanism
- Thrombin exogenous protein
- Action type
- EXOGENOUS_PROTEIN
- Target
- Prothrombin
- Protein identifier
- P00734
- Mechanism
- Vitamin K-dependent protein C exogenous protein
- Action type
- EXOGENOUS_PROTEIN
- Target
- Vitamin K-dependent protein C
- Protein identifier
- P04070
- Mechanism
- Vitamin K-dependent protein S exogenous protein
- Action type
- EXOGENOUS_PROTEIN
- Target
- Vitamin K-dependent protein S
- Protein identifier
- P07225
- Mechanism
- Coagulation factor IX exogenous protein
- Action type
- EXOGENOUS PROTEIN
- Target
- Coagulation factor IX
- Mechanism
- Coagulation factor VII exogenous protein
- Action type
- EXOGENOUS PROTEIN
- Target
- Coagulation factor VII
- Mechanism
- Coagulation factor X exogenous protein
- Action type
- EXOGENOUS PROTEIN
- Target
- Coagulation factor X
- Mechanism
- Thrombin exogenous protein
- Action type
- EXOGENOUS PROTEIN
- Target
- Prothrombin
- Mechanism
- Vitamin K-dependent protein C exogenous protein
- Action type
- EXOGENOUS PROTEIN
- Target
- Vitamin K-dependent protein C
- Mechanism
- Vitamin K-dependent protein S exogenous protein
- Action type
- EXOGENOUS PROTEIN
- Target
- Vitamin K-dependent protein S
Investigated indications
- Condition
- Thrombosis
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0000831
- Subject identifier
- D013927
- Condition identifier
- EFO_0000551
- Condition identifier
- EFO_0009579
- Condition identifier
- EFO_0010673
- Highest recorded phase
- 3
- Condition identifier
- EFO_1001373
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0000831
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0001531
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0002242
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0002244
- Condition identifier
- MONDO_0020599
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0021178
- Highest recorded phase
- 3
- Condition identifier
- MP_0001914
- Highest recorded phase
- 3
- Event
- acute myocardial infarction
- Reports
- 9
- Reporting signal score
- 9.55456
- Event
- altered state of consciousness
- Reports
- 9
- Reporting signal score
- 11.6822
- Event
- aphasia
- Reports
- 7
- Reporting signal score
- 6.79588
- Event
- cerebral artery embolism
- Reports
- 3
- Reporting signal score
- 8.81989
- Event
- cerebral haemorrhage
- Reports
- 10
- Reporting signal score
- 14.4368
- Event
- cerebral infarction
- Reports
- 29
- Reporting signal score
- 65.1834
- Event
- deep vein thrombosis
- Reports
- 43
- Reporting signal score
- 72.3111
- Event
- device connection issue
- Reports
- 4
- Reporting signal score
- 13.7846
- Event
- device defective
- Reports
- 5
- Reporting signal score
- 12.2017
- Event
- diarrhoea
- Reports
- 1
- Reporting signal score
- 17.3517
- Event
- disseminated intravascular coagulation
- Reports
- 13
- Reporting signal score
- 30.6209
- Event
- dizziness
- Reports
- 3
- Reporting signal score
- 7.82209
- Event
- embolic cerebral infarction
- Reports
- 4
- Reporting signal score
- 14.56
- Event
- embolic stroke
- Reports
- 11
- Reporting signal score
- 33.0611
- Event
- embolism
- Reports
- 6
- Reporting signal score
- 11.2894
- Event
- embolism venous
- Reports
- 5
- Reporting signal score
- 12.5062
- Event
- haemorrhagic infarction
- Reports
- 3
- Reporting signal score
- 11.5183
- Event
- headache
- Reports
- 4
- Reporting signal score
- 8.63983
- Event
- hemiplegia
- Reports
- 9
- Reporting signal score
- 21.4379
- Event
- hepatic function abnormal
- Reports
- 10
- Reporting signal score
- 9.35486
- Event
- infusion site extravasation
- Reports
- 14
- Reporting signal score
- 40.2327
- Event
- international normalised ratio increased
- Reports
- 9
- Reporting signal score
- 7.56067
- Event
- intracardiac thrombus
- Reports
- 4
- Reporting signal score
- 9.87876
- Event
- monoplegia
- Reports
- 4
- Reporting signal score
- 9.23851
- Event
- nausea
- Reports
- 1
- Reporting signal score
- 21.9889
And 15 more, listed on the interactive page.
Trial references
- NCT02270918
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
Related records
Trials (53)
- A Study to Assess the Effects of 2 Different Prothrombin Complex Concentrates on the Pharmacodynamics of Rivaroxaban in Healthy Adult Volunteers
- A Study to Assess the Effects of 2 Prothrombin Complex Concentrates on the Pharmacodynamics of Apixaban in Healthy Adult Subjects
- A Study to Assess the Independent Effects of 4-Factor Prothrombin Complex Concentrate and Tranexamic Acid on Bleeding/Pharmacodynamics in Healthy Participants
- A Study to Assess the Reversal of the Anticoagulant Effects of Milvexian by 4-Factor Prothrombin Complex Concentrate (4F-PCC) (Part 1) and Recombinant Human Factor VIIa (rFVIIa) (Part 2) in Healthy Participants
- A Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Male Subjects
- A Two-part Study in Edoxaban-treated Healthy Subjects to Establish a Punch Biopsy Bleeding Model and to Evaluate the Effect of a 4-factor Prothrombin Complex Concentrate on Anticoagulation
- Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery
- Administration of Prothrombin Complex Concentrate vs. Standard Transfusion During/After Heart Transplantation
- An Observational Cohort Study to Investigate the Risk of Thromboembolic Events in Patients Receiving Kcentra® or Plasma to Reverse Vitamin K Antagonist (VKA) Therapy in the Setting of Acute Major Bleeding
- An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N (Kcentra) Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure
- Assessment of Coagulation Factor Levels in Left Ventricular Device (LVAD )Patients Following Temporary Warfarin Reversal With Four Factor Prothrombin Complex Concentrate (4F-PCC)
- Carboplatin + Paclitaxel + Cetuximab (PCC) After Failure of Pembrolizumab +/- First-line Chemotherapy in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
- Coagulation in Cirrhosis
- CPP Versus PFC to Correct Coagulation Disorders in Adult Neurosurgical Patients
- Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB)
- Efficacy and Safety of Early Use PCC in Severe Trauma
- Efficacy and Safety of Prothromplex Total (Prothrombin Complex Concentrate) in Oral Anticoagulant Reversal
- Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy
- Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery
- Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )
In development for (2)
- Acquired coagulation factor deficiency Phase 3
- Thrombotic disease Phase 1