Drugs / EFTRENONACOG ALFA
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Alprolix | — | 2016-05-12 | europa.eu ↗ |
Trials 6 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03272568 | Feb 2018 → Dec 2019 | hemophilia, menstrual disorder | Emory University | Completed | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT00716716 | Apr 2008 → Oct 2009 | hemophilia B | Bioverativ Therapeutics Inc. | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT02234310 | Nov 2014 → Aug 2019 | hemophilia B | Bioverativ, a Sanofi company | Completed | No outcome recorded |
| Phase 3 | NCT01440946 | Jun 2012 → Nov 2014 | hemophilia B | Bioverativ Therapeutics Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01425723 | Dec 2011 → Oct 2017 | severe hemophilia B | Bioverativ Therapeutics Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01027364 | Dec 2009 → Jul 2012 | severe hemophilia B | Bioverativ Therapeutics Inc. | Completed | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT03075670 Comparator | Mar → Dec 2017 | congenital hematological disorder, hemophilia B | Novo Nordisk A/S | Completed | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | EFTRENONACOG ALFA | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594598 ↗ |
| Known as | ALPROLIX | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03075670 ↗ |
| Known as | BIIB-029 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594598 ↗ |
| Known as | Recombinant factor IX-Fc fusion protein | “Recombinant factor IX-Fc fusion protein (rFIXFc) demonstrates safety and prolonged activity in a phase 1/2a study in hemophilia B patients.” PMID 22110246 ↗ Nov 2011 |
| Known as | rFIXFc | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01440946 ↗ |
| Action | Restore | “Subjects will get FIX activity corrected from the baseline level to 100-150% with Alprolix” NCT03272568 ↗ |
| Modality | Protein / enzyme biologic | “rFIXFc is a recombinant fusion protein composed of FIX and the Fc domain of human IgG(1), to extend circulating time.” PMID 22110246 ↗ Nov 2011 |
| Route | Intravenous | “A Phase I/IIa Safety and Pharmacokinetic Study of Intravenous FIXFc in Previously Treated Hemophilia B Patients” NCT00716716 ↗ |
| Target | F9 | “Coagulation factor IX exogenous protein” CHEMBL4594598 ↗ |