11 completed, 3 active not recruiting, 1 not yet recruiting, 1 terminated. 17 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 17 | Completed 11, Active not recruiting 3, Not yet recruiting 1, Terminated 1, Withdrawn 1 |
Follow Severe Hemophilia A: new trials by email Literature Review of Severe Hemophilia A trials Research Report on Severe Hemophilia A
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 |
|---|---|---|---|---|---|---|
| Study of Efficacy and Safety of FRSW107 in Pediatric Patients With Severe Hemophilia A FRSW107 - Severe Hemophilia A | Phase 3 | Not yet recruiting | Hangzhou Gensciences Biopharmaceutical Co., Ltd. | 76 | 2026-12-25 | 2024-06-20 |
| Study of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein (FRSW107) as Prophylactic Treatment. FRSW107 - Severe Hemophilia A | Phase 3 | Active not recruiting | Hangzhou Gensciences Biopharmaceutical Co., Ltd. | 60 | 2026-06-12 | 2026-09-04 |
| Study of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein (FRSW107) On-Demand Treatment FRSW107 - Severe Hemophilia A | Phase 3 | Active not recruiting | Hangzhou Gensciences Biopharmaceutical Co., Ltd. | 60 | 2026-04-14 | 2026-09-08 |
| Phase 3 Clinical Project of Pegylated Recombinant Human Coagulation Factor VIII-Fc Fusion Protein FRSW117 - Severe Hemophilia A | Phase 3 | Completed | Hangzhou Gensciences Biopharmaceutical Co., Ltd. | 124 | 2023-12-27 | 2026-09-09 |
| rFVIII-Fc (Produced by AryoGen Pharmed Co.) Pharmacokinetic Study Factor VIII, recombinant human with Fc fusion (rFVIII-Fc) - Severe Hemophilia A | Phase 3 | Completed | AryoGen Pharmed Co. | 50 | 2023-07-22 | 2023-11-18 |
| A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Emicizumab in Participants From Birth to 12 Months of Age With Hemophilia A Without Inhibitors Emicizumab - Severe Hemophilia A | Phase 3 | Active not recruiting | Hoffmann-La Roche | 55 | 2021-02-04 | 2026-10-01 |
| Hemophilia Inhibitor Clinical Trials (INHIBIT) Platform Eloctate Prophylaxis, Emicizumab Prophylaxis, Eloctate ITI plus Emicizumab - Severe Hemophilia A | Phase 3 | Withdrawn | Margaret Ragni | 2020-08-01 | 2019-08-20 | |
| Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Wilate in Previously Treated Paediatric Patients With Severe Haemophilia A Wilate - Severe Hemophilia A | Phase 3 | Completed | Octapharma | 11 | 2017-11-22 | 2021-01-19 |
| Clinical Study to Investigate the PK, Efficacy, and Safety of Wilate in Patients With Severe Hemophilia A Wilate - Severe Hemophilia A | Phase 3 | Completed | Octapharma | 57 | 2016-12-01 | 2021-01-19 |
| Pharmacokinetics and Safety of rFVIIIFc Manufactured at 15,000 L (15K) Scale rFVIIIFc - Severe Hemophilia A | Phase 3 | Completed | Bioverativ Therapeutics Inc. | 24 | 2015-08-01 | 2020-12-19 |
| An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A rVIII-SingleChain - Hemophilia A, Severe Hemophilia A | Phase 3 | Completed | CSL Behring | 246 | 2014-10-13 | 2021-10-27 |
| Study to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII Human-cl rhFVIII - Severe Hemophilia A | Phase 3 | Completed | Octapharma | 48 | 2014-04-01 | 2021-01-19 |
| Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients Human cl rhFVIII - Severe Hemophilia A | Phase 3 | Completed | Octapharma | 110 | 2013-02-01 | 2021-01-19 |
| Hemophilia Adult Prophylaxis Study: Factor VIII in Severe Hemophilia A rF.VIII - Severe Hemophilia A | Phase 3 | Terminated | University of Pittsburgh | 4 | 2012-07-01 | 2016-10-07 |
| Study to Investigate the Long-term Efficacy and Safety of Human-cl rhFVIII in Previously Treated Patients (PTPs) Human-cl rhFVIII - Severe Hemophilia A | Phase 3 | Completed | Octapharma | 3 | 2011-06-01 | 2020-03-17 |
| Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Subjects With Severe Hemophilia A Factor VIII (rFVIIIFc), Advate® - Severe Hemophilia A | Phase 3 | Completed | Bioverativ Therapeutics Inc. | 165 | 2010-11-01 | 2021-01-08 |
| Efficacy and Safety Study of Human-cl rhFVIII in PTPs With Severe Hemophilia A recombinant Factor VIII - Severe Hemophilia A | Phase 3 | Completed | Octapharma | 32 | 2010-06-01 | 2017-09-11 |
Hemophilia A (17)
Blood Coagulation Disorders (17) · Blood Coagulation Disorders, Inherited (17) · Coagulation Protein Disorders (17) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (17) · Genetic Diseases, Inborn (17) · Hematologic Diseases (17) · Hemic and Lymphatic Diseases (17) · Hemorrhagic Disorders (17)
Factor VIII (6) · Injections (2) · emicizumab (2) · von Willebrand Factor (2) · F8 protein, human (1) · factor VIII-Fc fusion protein (1)
Octapharma (6) · Hangzhou Gensciences Biopharmaceutical Co., Ltd. (4) · Bioverativ Therapeutics Inc. (2) · AryoGen Pharmed Co. (1) · CSL Behring (1) · Hoffmann-La Roche (1) · Margaret Ragni (1) · University of Pittsburgh (1)
United States (9) · United Kingdom (6) · Canada (5) · France (5) · Germany (5) · Australia (4) · Austria (4) · China (4) · Italy (4) · Poland (4) · Spain (4) · Ukraine (4) · Bulgaria (3) · Georgia (3) · India (3)
Cristina Solomon, MD (2) · Renchi Yang, PhD (2) · Aziz Eghbali, Assoc. Prof. (1) · Johannes Oldenburg, Prof. (1) · Margaret V Ragni, MD, MPH (1) · Margaret V. Ragni, MD, MPH (1) · Renchi Yang (1) · Sigurd Knaub (1) · Sigurd Knaub, PhD (1)
PMID 24227821, PMID 25196897, PMID 31003964, PMID 33719084, PMID 34435432, PMID 36636993, PMID 38127586, PMID 39091324, PMID 39934428
2014 (1), 2023 (1), R34HL105870 (1)