10 completed, 1 terminated. 3 Phase 3, 2 Phase 1, 1 Early Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 3 | Completed 3 |
| Phase 1 | 2 | Completed 2 |
| Early Phase 1 | 1 | Completed 1 |
Follow factor IX Fc fusion protein: new trials by email Literature Review of factor IX Fc fusion protein trials Research Report on factor IX Fc fusion protein
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| An International Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B Alprolix - Hemophilia B | Completed | Swedish Orphan Biovitrum | 151 | 2019-09-12 | 2025-09-29 | |
| A Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B in France Alprolix - Haemophilia B | Completed | Swedish Orphan Biovitrum | 91 | 2018-09-12 | 2024-09-19 | |
| Extended Half Life Factor (EHF) Products For Heavy Menstrual Bleeding in Hemophilia Carriers Recombinant FVIII Fc fusion product Eloctate, Recombinant FIX Fc fusion product Alprolix, Patient-operated diagnostic device for anemia AnemoCheck. - Hemophilia, Menstrual Flow Excessive | Early Phase 1 | Completed | Emory University | 3 | 2018-02-14 | 2020-05-18 |
| A Study to Evaluate the Real-world Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B ELOCTA, ALPROLIX - Haemophilia A, Haemophilia B | Completed | Swedish Orphan Biovitrum | 201 | 2017-05-09 | 2024-10-02 | |
| A Trial Comparing Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B N9-GP, ALPROLIX® - Congenital Bleeding Disorder, Haemophilia B | Phase 1 | Completed | Novo Nordisk A/S | 15 | 2017-03-07 | 2023-05-26 |
| ATHN 2: Factor Switching Study Factor VIII Replacement Products for Hemophilia which were FDA approved after January 1, 2013, Factor IX Replacement Products for Hemophilia which were FDA approved after January 1, 2013 - Hemophilia | Completed | American Thrombosis and Hemostasis Network | 310 | 2015-09-01 | 2021-12-09 | |
| Fc factOrs and Real-World hemophiliA Patient-ReporteD Outcomes rFVIIIFc, rFIXFc, non-Fc FVIII replacement products - Hemophilia A, Hemophilia B | Terminated | Bioverativ Therapeutics Inc. | 3 | 2015-07-01 | 2020-12-19 | |
| Study to Determine the Safety and Efficacy of rFIXFc in Previously Untreated Males With Severe Hemophilia B rFIXFc - Hemophilia B | Phase 3 | Completed | Bioverativ, a Sanofi company | 33 | 2014-11-13 | 2022-03-25 |
| Study of Recombinant Coagulation Factor IX Fc Fusion Protein, BIIB029, in Previously Treated Pediatric Participants With Hemophilia B rFIXFc, FIX - Hemophilia B | Phase 3 | Completed | Bioverativ Therapeutics Inc. | 30 | 2012-06-01 | 2020-12-19 |
| Long-Term Safety and Efficacy of rFIXFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia B rFIXFc - Severe Hemophilia B | Phase 3 | Completed | Bioverativ Therapeutics Inc. | 120 | 2011-12-08 | 2020-12-19 |
| Phase I/IIa Study of FIXFc in Hemophilia B Patients rFIXFc - Hemophilia B | Phase 1 | Completed | Bioverativ Therapeutics Inc. | 10 | 2008-04-01 | 2020-12-19 |
Hemophilia B (9) · Hemophilia A (4) · Blood Coagulation Disorders (3) · Coagulation Protein Disorders (3) · Genetic Diseases, Inborn (3) · Hematologic Diseases (3) · Hemorrhagic Disorders (3) · Hemorrhage (1) · Menorrhagia (1) · Thrombosis (1)
Bioverativ Therapeutics Inc. (4) · Swedish Orphan Biovitrum (3) · American Thrombosis and Hemostasis Network (1) · Bioverativ, a Sanofi company (1) · Emory University (1) · Novo Nordisk A/S (1)
United States (8) · Ireland (4) · United Kingdom (4) · Australia (3) · France (3) · Germany (3) · Italy (3) · Netherlands (3) · Sweden (3) · Poland (2) · South Africa (2) · Belgium (1) · Brazil (1) · Canada (1) · China (1)
Elena Santagostino, MD (2) · Ellis J Neufeld, MD, PhD (1) · Janna Journeycake, MD (1) · Robert Sidonio, MD, MSc (1)
PMID 36848635, PMID 22110246, PMID 28159192, PMID 30656283, PMID 31011711, PMID 34242387, PMID 37283819, PMID 38922990, PMID 39872008
2016 (1)