18 completed, 5 active not recruiting, 3 recruiting, 3 terminated. 17 Phase 3, 6 Phase 1, 4 Not applicable, 4 Phase 4, 3 Phase 2.
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 |
|---|---|---|---|---|---|---|
| Post Approval Phase 4 Study to Learn More About How Safe Octocog Alfa is, and How Well it Works in Patients With Severe Hemophilia A in India Octocog alfa - Severe Hemophilia A | Not yet recruiting | Bayer | 30 | 2027-04-05 | 2026-10-21 | |
| 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 |
| Palliative Care Needs of Children With Rare Diseases and Their Families Family Centered pediatric palliative care for family caregivers of children with rare diseases. - Trisomy 13 Syndrome, Arthrogryposis Congenita Multiplex With Intestinal Atresia | Not applicable | Enrolling by invitation | Children's National Research Institute | 480 | 2025-10-02 | 2026-01-28 |
| A Study to Learn About How Changing Therapy From Emicizumab to Marstacimab Affects People With the Severe Hemophilia A. MARSTACIMAB - Severe Hemophilia A | Phase 1 | Recruiting | Pfizer | 15 | 2025-05-13 | 2026-10-15 |
| 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 |
| Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study Nuwiq - Severe Hemophilia A | Phase 4 | Recruiting | Octapharma | 28 | 2023-11-28 | 2026-05-12 |
| Bone Microarchitecture in Men With Hemophilia HR-pQCT, Blood sample, Dual energy X-ray absorptiometry - Severe Hemophilia A, Osteoporosis | Not applicable | Terminated | Hospices Civils de Lyon | 10 | 2023-08-01 | 2024-04-18 |
| 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 |
| To Evaluate the Safety and Efficacy of GS1191-0445 Injection in the Treatment of Severe Hemophilia A GS1191-0445 injection - Severe Hemophilia A | Phase 1 / Phase 2 | Active not recruiting | Gritgen Therapeutics Co., Ltd. | 7 | 2023-07-10 | 2026-05-06 |
| Dynamics of the Anti-factor VIII Antibody Signature During Treatment With Emicizumab no interventions - Severe Hemophilia A, Severe Hemophilia A With Inhibitor | Recruiting | Christoph Königs | 100 | 2023-04-26 | 2023-07-10 | |
| A Study to Evaluate Overall Health, Physical Activity, and Joint Outcomes in Participants With Severe or Moderate Hemophilia A Without Factor VIII Inhibitors on Emicizumab Prophylaxis Emicizumab - Severe Hemophilia A, Moderate Hemophilia A | Phase 4 | Active not recruiting | Hoffmann-La Roche | 136 | 2022-06-20 | 2026-10-23 |
| A Study of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection FRSW117 - Severe Hemophilia A | Phase 2 | Completed | Hangzhou Gensciences Biopharmaceutical Co., Ltd. | 15 | 2022-04-14 | 2023-05-15 |
| A Study to Evaluate the Pharmacokinetics，Safety and Tolerability of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection ADVATE, FRSW117 - Severe Hemophilia A | Phase 1 | Completed | Hangzhou Gensciences Biopharmaceutical Co., Ltd. | 13 | 2021-06-22 | 2023-09-08 |
| 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 | |
| Safety and Pharmacokinetics of Subcutaneous Injection of OCTA101 in Adult Patients With Severe Hemophilia A OCTA101 - Severe Hemophilia A | Phase 1 / Phase 2 | Terminated | Octapharma | 36 | 2019-07-03 | 2026-10-15 |
| 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 |
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Hemophilia A (34) · Anxiety Disorders (1) · Blood Coagulation Disorders (1) · Blood Coagulation Disorders, Inherited (1) · CHARGE Syndrome (1) · Coagulation Protein Disorders (1) · Cockayne Syndrome (1) · Depression (1) · Factor VII Deficiency (1) · Genetic Diseases, Inborn (1) · Hematologic Diseases (1) · Hemorrhagic Disorders (1) · Hernias, Diaphragmatic, Congenital (1) · Infantile Epileptic-Dyskinetic Encephalopathy (1) · KBG syndrome (1)
Congenital, Hereditary, and Neonatal Diseases and Abnormalities (34) · Hemic and Lymphatic Diseases (34) · Blood Coagulation Disorders (33) · Blood Coagulation Disorders, Inherited (33) · Coagulation Protein Disorders (33) · Genetic Diseases, Inborn (33) · Hematologic Diseases (33) · Hemorrhagic Disorders (33) · Bone Diseases (2) · Metabolic Diseases (2) · Musculoskeletal Diseases (2) · Nutritional and Metabolic Diseases (2) · Abnormalities, Multiple (1) · Behavior (1) · Behavioral Symptoms (1)
Factor VIII (13) · Injections (4) · von Willebrand Factor (4) · F8 protein, human (3) · emicizumab (3) · factor VIII-Fc fusion protein (3) · factor VIII, von Willebrand factor drug combination (2) · optivate (2) · Absorptiometry, Photon (1) · Blood Specimen Collection (1) · marstacimab (1) · recombinant factor VIII SQ (1)
Octapharma (8) · Hangzhou Gensciences Biopharmaceutical Co., Ltd. (6) · Bioverativ Therapeutics Inc. (4) · City of Hope Medical Center (2) · Hoffmann-La Roche (2) · AryoGen Pharmed Co. (1) · Bayer (1) · CSL Behring (1) · Children's National Research Institute (1) · Christoph Königs (1) · Grifols Biologicals, LLC (1) · Gritgen Therapeutics Co., Ltd. (1) · Hospices Civils de Lyon (1) · Margaret Ragni (1) · Pfizer (1)
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Renchi Yang, PhD (4) · Cristina Solomon, MD (2) · Aziz Eghbali, Assoc. Prof. (1) · Brian M Feldman, MD (1) · Christoph Koenigs, PD Dr. Dr (1) · Johannes Oldenburg, Prof. (1) · Margaret V Ragni, MD, MPH (1) · Margaret V. Ragni, MD, MPH (1) · Maureen E Lyon, PhD (1) · Michael Ken Woodward (1) · Nadia P Ewing, MD (1) · Nadia P. Ewing, MD (1)
PMID 33719084, PMID 22223821, PMID 24227821, PMID 25196897, PMID 29731369, PMID 31003964, PMID 34435432, PMID 36636993, PMID 38127586, PMID 39091324, PMID 39934428, PMID 41151952
2008 (2), 2023 (2), 2014 (1), R01HD117137 (1), R34HL105870 (1)