Overview
Prothrombin Complex Concentrate (Human), is indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding.
Indication
For use in the emergency reversal of coagulation factor deficiency in patients receiving vitamin K antagonist therapy. Prothrombin is administered as part of a cocktail containing several coagulation factors.
Associated Conditions
- Bleeding
- Vitamin K antagonist induced major bleeding
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/11/26 | N/A | Not yet recruiting | University Hospital, Strasbourg, France | ||
2024/05/28 | N/A | Recruiting | |||
2022/10/06 | Phase 3 | Terminated | |||
2022/08/31 | Phase 3 | Completed | |||
2021/04/30 | Phase 3 | Recruiting | |||
2020/01/28 | Phase 4 | Recruiting | Chinese Academy of Medical Sciences, Fuwai Hospital | ||
2019/07/15 | Phase 2 | Active, not recruiting | |||
2018/12/24 | Not Applicable | Completed | Angel Augusto Perez Calatayud | ||
2018/10/23 | Phase 2 | Completed | |||
2018/03/22 | Phase 4 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| OCTAPLEX POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 500 IU | SIN14933P | INJECTION, POWDER, FOR SOLUTION | 280 - 760 IU/vial | 1/28/2016 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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