Drugs / Factor VIII Inhibitor Bypassing Activity
Factor VIII Inhibitor Bypassing Activity
also known as
FEIBA · activated prothrombin complex concentrate · aPCC · Factor Eight Inhibitor Bypassing Activity
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 32 trials | ||||||
| Phase 3 | NCT04563520 | Jun 2026 → Mar 2027 expected | hemophilia A | Emory University | Recruiting | No outcome recorded |
| Phase 3 | NCT02764489 | Feb 2019 → Dec 2021 | hemophilia | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT04205175 | Jul 2020 → Oct 2022 overdue | hemophilia A | Children's Hospital Los Angeles | Active not recruiting | No outcome recorded |
| Phase 4 | NCT00284193 | Jan 2005 → Nov 2008 | hemophilia A | Sheba Medical Center | Completed | No outcome recorded |
| Phase not applicable1 trial · 1 missed | ||||||
| — | NCT00166309 | Jul 2000 → Jun 2005 | severe hemophilia A | Skane University Hospital | Completed | Missed primary |
| Comparator or background therapy3 trials | ||||||
| Phase 3 | NCT05662319 Background | Feb 2023 → Mar 2027 expected | hemophilia | Sanofi | Active not recruiting | No outcome recorded |
| Phase 3 | NCT00851721 Comparator | Mar 2009 → Oct 2012 | hemophilia A, hemophilia B | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 4 | NCT01800435 Comparator | Oct 2011 → Oct 2012 | hemophilia A | Oslo University Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2017-02-01 | Takeda | Results New data from Shire aim to help close the diagnosis and treatment gap for people with Hemophilia takeda.com ↗
Results found a multi-fold increase in thrombin generation, indicating a potential thrombotic risk, for patients who receive the investigational agent combined with FEIBA or rFVIIa. |
| 2016-12-02 | Takeda | Results Shire reports on four decades of real-world safety experience with FEIBA® [Anti-Inhibitor Coagulant Complex] takeda.com ↗
The global review of safety databases for AE reports of FEIBA received from 1975 through July 2016 showing the reporting rate of TEEs associated with FEIBA is comparable with previously reported data. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2017-02-01 | Takeda | New data from Shire aim to help close the diagnosis and treatment gap for people with Hemophilia takeda.com ↗ |
| 2016-12-02 | Takeda | Shire reports on four decades of real-world safety experience with FEIBA® [Anti-Inhibitor Coagulant Complex] takeda.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | factor VIII inhibitor-bypassing activity | “FEIBA (factor VIII inhibitor-bypassing activity), an activated prothrombin complex concentrate (aPCC), and NovoSeven, recombinant factor VIIa (rFVIIa), are used as hemostatic...” PMID 16990605 ↗ Sep 2006 |
| Known as | activated prothrombin complex concentrate | “bypassing agents such as activated prothrombin complex concentrate (aPCC/Feiba)” NCT04205175 ↗ |
| Known as | aPCC | “bypassing agents such as activated prothrombin complex concentrate (aPCC/Feiba)” NCT04205175 ↗ |
| Known as | Factor Eight Inhibitor Bypassing Activity | “Treatment with the nanofiltered anti-inhibitor coagulant complex, Factor Eight Inhibitor Bypassing Activity (FEIBA NF), is a key therapeutic option for controlling acute...” PMID 23910578 ↗ Aug 2013 |
| Known as | FEIBA | “A Study to Evaluate the Safest Dose Range for FEIBA in Hemophilia A Patients With Inhibitors on Emicizumab” NCT04205175 ↗6“Feiba 75 IU/kg i.v Feiba 75 IU/kg i.v +Cyklokapron 20 mg/kg p.o” NCT01800435 ↗ |
| Modality | Protein / enzyme biologic | “Activated Prothrombin Complex Concentrates (APCC, eg. FEIBA)” NCT00284193 ↗ |
| Route | Intravenous | “Feiba 75 IU/kg i.v” NCT01800435 ↗ |