Factor VIII-Fc fusion protein clinical trials
Also written Eloctate, Elocta, efmoroctocog alfa and BIIB031.
How each study uses factor VIII-Fc fusion protein is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study
Approvals
The first approval found in each region, with its record
- United States
- 6 Jun 2014 · Eloctate · BLA 125487 (FDA, Purple Book)
- European Union
- 18 Nov 2015 · Elocta · EMEA/H/C/003964 (EMA)
From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out
How studies write it
Studies that test it under each name
Name
Development codes
- BIIB031
- 2
Studies by the year they started
12 studies that test it; most in 2017 (3)
| Year | Studies |
|---|---|
| 2009 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| 2015 | 2 |
| 2017 | 3 |
| 2018 | 1 |
| 2021 | 2 |
By phase
A phase 1/2 study counts in both.
What it is tested for
Each study’s main condition, where its own words name it, so a study counts once.
Who runs them
Industry 9 · Other 3
Bioverativ Therapeutics Inc. (5) · Bioverativ, a Sanofi company (2) · Swedish Orphan Biovitrum (1) · The League of Clinical Research, Russia (1) · Emory University (1) · Bayer (1) · University of Texas Southwestern Medical Center (1)
Often tested with
Tested in the same studies.
Factor IX Fc fusion protein (1) · BAX 855 (1) · Emicizumab (1)
Studies
Open first, then newest update. How each study uses factor VIII-Fc fusion protein is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.
Testing it · 12
- POCUS: Hemostatic Potential and Joint Health in Patients With Severe Hemophilia A on Novel Replacement TherapiesWithdrawnPhase 4University of Texas Southwestern Medical CenterNCT04690322Written as Eloctate
- Study of rFVIIIFc for Immune Tolerance Induction (ITI) in Haemophilia A Patients With Inhibitors Who Have Failed Previous ITI TherapiesCompletedPhase 4Swedish Orphan BiovitrumNCT03103542Written as Recombinant coagulation factor (rFVIIIFc)
- Health Related Quality of Life of Youth and Young Adults With Haemophilia ACompletedPhase 4The League of Clinical Research, RussiaNCT04728217Written as Efmoroctocog Alfa Injection [Eloctate]
- An Open Label Study to Determine the Safety and Efficacy of Replacement Factor VIII Protein (Known as rFVIIIFc) in Previously Untreated Males With Severe Hemophilia ACompletedPhase 3Bioverativ, a Sanofi companyNCT02234323Written as rFVIIIFc
- A Study to Evaluate Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Participants With Inhibitors Undergoing the First ITI Treatment (verITI-8 Study)CompletedPhase 4Bioverativ, a Sanofi companyNCT03093480Written as rFVIIIFc
- Pharmacokinetics of rFVIIIFc at Two Vial StrengthsCompletedPhase 1Bioverativ Therapeutics Inc.NCT02083965Written as rFVIIIFc
- Long-Term Safety and Efficacy of rFVIIIFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia ACompletedPhase 3Bioverativ Therapeutics Inc.NCT01454739Written as rFVIIIFc
- Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Pediatric Subjects With Hemophilia ACompletedPhase 3Bioverativ Therapeutics Inc.NCT01458106Written as BIIB031 (rFVIIIFc)
- Pharmacokinetics and Safety of rFVIIIFc Manufactured at 15,000 L (15K) ScaleCompletedPhase 3Bioverativ Therapeutics Inc.NCT02502149Written as rFVIIIFc
- Study of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Subjects With Severe Hemophilia ACompletedPhase 1Bioverativ Therapeutics Inc.NCT01027377Written as rFVIIIFc
- Extended Half Life Factor (EHF) Products For Heavy Menstrual Bleeding in Hemophilia CarriersCompletedEarly Phase 1Emory UniversityNCT03272568Written as Recombinant FVIII Fc fusion product Eloctate
- BAY94-9027 PK Study Comparing to Another Long Acting ProductCompletedPhase 1BayerNCT03364998Written as Elocta
Given beside what is tested · 1 — factor VIII-Fc fusion protein is usual care or a partner of the new treatment
As the comparator · 1 — what is tested is compared with factor VIII-Fc fusion protein
Codes
What other systems call factor VIII-Fc fusion protein · ClinicalTrials.gg INT006454
- RxNorm 1543095One source FDA
| System | Code | Name there | Checked by |
|---|---|---|---|
| RxNorm | 1543095 | — | One source FDA |
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.