Overview
Anti-inhibitor coagulant complex, also known as FEIBA (factor eight inhibitor bypassing activity), contains several proteins involved in the prothrombinase complex. It is used to control bleeding in hemophilia A and B patients with inhibitors.
Background
Anti-inhibitor coagulant complex, also known as FEIBA (factor eight inhibitor bypassing activity), contains several proteins involved in the prothrombinase complex. It is used to control bleeding in hemophilia A and B patients with inhibitors.
Indication
For use in the control of bleeding episodes, perioperative management, and routine prophylaxis against bleeding episodes in hemophilia A and B patients with inhibitors. It is not indicated in the absence of factor VIII or IX inhibitors.
Associated Conditions
- Bleeding caused by Hemophilia A
- Bleeding caused by Hemophilia B
- Perioperative bleeding caused by Hemophilia A
- Perioperative bleeding caused by Hemophilia B
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/24 | Phase 2 | Not yet recruiting | |||
2025/03/19 | N/A | Recruiting | |||
2021/08/25 | Phase 2 | Withdrawn | |||
2020/09/24 | Phase 3 | Recruiting | |||
2019/12/19 | Phase 4 | Active, not recruiting | |||
2015/10/16 | Phase 1 | Completed | |||
2008/07/04 | N/A | Completed | |||
2005/09/14 | Not Applicable | Completed | |||
2005/04/19 | Phase 4 | Completed |
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 |
|---|---|---|---|---|---|
| FEIBA 1000 U | SIN10886P | INJECTION, POWDER, FOR SOLUTION | 50 u/ml | 4/20/1999 | |
| FEIBA 500 U | SIN10889P | INJECTION, POWDER, FOR SOLUTION | 25 u/ml | 4/20/1999 |
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
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| FEIBA-NF factor VIII inhibitor bypassing fraction 2500U powder for injection vial with diluent vial | 172236 | Medicine | A | 3/30/2012 | |
| FEIBA-NF factor eight inhibitor bypassing fraction 1000U powder for injection vial with diluent vial | 104911 | Medicine | A | 1/9/2007 | |
| FEIBA-NF factor eight inhibitor bypassing fraction 500U powder for injection vial with diluent vial | 104896 | Medicine | A | 1/9/2007 |