50 completed. 50 Phase 3, 6 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 50 | Completed 50 |
| Phase 2 | 6 | Completed 6 |
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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 |
|---|---|---|---|---|---|---|
| Recombinant Single-chain Factor VIII (rVIII-SingleChain) in Chinese Participants With Hemophilia A Previously Treated With FVIII Products Recombinant single-chain factor VIII (rVIII-SingleChain) - Congenital Hemophilia A | Phase 3 | Completed | CSL Behring | 62 | 2025-01-09 | 2026-10-23 |
| Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Chinese Subjects With Hemophilia B Previously Treated With FIX Therapy Recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) - Hemophilia B | Phase 3 | Completed | CSL Behring | 23 | 2024-07-28 | 2026-07-23 |
| CSL312_3003 Safety and Pharmacokinetic Study in Subjects 2 to 11 Years of Age With Hereditary Angioedema CSL312 - Hereditary Angioedema (HAE) | Phase 3 | Completed | CSL Behring | 22 | 2023-05-30 | 2026-06-02 |
| Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks CSL312 - Hereditary Angioedema | Phase 3 | Completed | CSL Behring | 171 | 2021-03-29 | 2026-06-02 |
| CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks CSL312, Placebo - Hereditary Angioedema | Phase 3 | Completed | CSL Behring | 64 | 2021-01-27 | 2023-06-29 |
| Treatment of GVHD in Hematopoietic Stem Cell Transplant (HSCT) Recipients Using AAT Plus Corticosteroids (CS) Compared With Corticosteroids Alone Alpha-1 antitrypsin (AAT), Placebo - Graft Versus Host Disease (GVHD) | Phase 3 | Completed | CSL Behring | 136 | 2020-01-09 | 2026-07-28 |
| HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B Patients AAV5-hFIXco-Padua, Factor IX (FIX) - Hemophilia B | Phase 3 | Completed | CSL Behring | 67 | 2018-06-27 | 2026-03-27 |
| Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome Apolipoprotein A-I [human] (apoA-I), Placebo - Acute Coronary Syndrome | Phase 3 | Completed | CSL Behring | 18226 | 2018-03-21 | 2025-01-14 |
| Effect of Privigen Against Graft Loss Privigen (Human normal immunoglobulin G (IgG > 98 % purity)) - Kidney Transplantation | Phase 3 | Completed | Assistance Publique - Hôpitaux de Paris | 18 | 2016-02-05 | 2021-03-09 |
| Investigating the Role of Early Intravenous Immunoglobulin Treatment for Children With Encephalitis Immunoglobulins, Intravenous (Privigen), Placebo - Encephalitis | Phase 3 | Completed | University of Oxford | 18 | 2016-01-01 | 2024-03-04 |
| A Study to Evaluate the Long-term Clinical Safety and Efficacy of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema C1-esterase inhibitor - Hereditary Angioedema Types I and II | Phase 3 | Completed | CSL Behring | 126 | 2014-12-31 | 2018-11-14 |
| 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 |
| A Pilot Trial To Assess The Feasibility And Efficacy Of SCIG In Patients With MG Exacerbation (SCIG-MG) Human normal immunoglobulin G (IgG) - Myasthenia Gravis | Phase 3 | Completed | University of Alberta | 26 | 2014-10-01 | 2023-02-21 |
| Study of a Prothrombin Complex Concentrate for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Japanese Subjects BE1116 (Prothrombin Complex Concentrate) - Acute Major Bleeding, Reversal of Coagulopathy | Phase 3 | Completed | CSL Behring | 11 | 2014-10-01 | 2016-05-04 |
| Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) IgPro20 - Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | Phase 3 | Completed | CSL Behring | 82 | 2014-07-30 | 2018-10-02 |
| Pharmacokinetic, Efficacy, and Safety Study of Recombinant Factor VIII Single Chain (rVIII-SingleChain) in Children With Severe Hemophilia A rVIII-SingleChain - Congenital Hemophilia A | Phase 3 | Completed | CSL Behring | 84 | 2014-03-01 | 2017-01-27 |
| A Safety and Efficacy Extension Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B rIX-FP - Hemophilia B | Phase 3 | Completed | CSL Behring | 97 | 2014-02-06 | 2022-07-14 |
| A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema Low-volume C1-esterase inhibitor, Higher-volume C1-esterase inhibitor, Low-volume placebo - Hereditary Angioedema Types I and II | Phase 3 | Completed | CSL Behring | 90 | 2014-01-01 | 2021-01-29 |
| A Safety, Efficacy and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Children With Hemophilia B rIX-FP - Hemophilia B | Phase 3 | Completed | CSL Behring | 27 | 2013-01-01 | 2016-05-09 |
| Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20) IgPro20 (low dose), Placebo, IgPro10 - Chronic Inflammatory Demyelinating Polyneuropathy, Polyradiculoneuropathy | Phase 3 | Completed | CSL Behring | 208 | 2012-03-01 | 2018-07-05 |
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Angioedemas, Hereditary (7) · Hemophilia B (7) · Hemophilia A (6) · Primary Immunodeficiency Diseases (6) · Common Variable Immunodeficiency (4) · Agammaglobulinemia (3) · Hemostatic Disorders (3) · IgG Deficiency (3) · Polyradiculoneuropathy, Chronic Inflammatory Demyelinating (3) · von Willebrand Diseases (3) · Factor XIII Deficiency (2) · Heart Diseases (2) · Hereditary Angioedema Types I and II (2) · Acquired Immunodeficiency Syndrome (1) · Acute Coronary Syndrome (1)
Hizentra (10) · Immunoglobulins, Intravenous (7) · gamma-Globulins (5) · Complement C1 Inhibitor Protein (4) · albutrepenonacog alfa (4) · Factor IX (3) · Fibrinogen (3) · Immunoglobulin G (3) · Albumins (2) · Factor VIII (2) · Proline (2) · alpha 1-Antitrypsin (2) · Apolipoprotein A-I (1) · CSL112 (1) · DNA, Ribosomal (1)
United States (25) · Germany (23) · Canada (16) · Spain (16) · Italy (15) · Japan (14) · Poland (14) · United Kingdom (14) · Australia (13) · Czechia (12) · France (12) · Israel (12) · Netherlands (11) · Romania (11) · Russia (11)
Andrew J Pollard, FRCPCH, PhD (1) · Arno P Nierich, MD, PhD. (1) · Cynthia L Bristow, PhD (1) · Danielle Duffy, MD (1) · Ingrid Pabinger-Fasching, Prof. (1) · Jose Cortes, MD (1) · Marco Ranucci, MD (1)
PMID 36326435, PMID 40386832, PMID 23987198, PMID 24412910, PMID 40380356, PMID 42268494, PMID 17479360, PMID 18208533, PMID 18814020, PMID 19635187, PMID 19767078, PMID 19787352, PMID 20217199, PMID 20454851, PMID 20674826, PMID 21195947, PMID 21553933, PMID 21674136, PMID 21705277, PMID 21884533, PMID 22856636, PMID 23781960, PMID 23935011, PMID 24229737, PMID 24266596, PMID 24504846, PMID 25377187, PMID 25728933, PMID 26037084, PMID 26135740, PMID 26755710, PMID 27317703, PMID 27330001, PMID 27455854, PMID 27583313, PMID 28241354, PMID 28328347, PMID 28594116, PMID 29122523, PMID 30462259, PMID 30772477, PMID 31485239, PMID 31824943, PMID 32042283, PMID 33588897, PMID 36812434, PMID 36868261, PMID 37522479, PMID 37945292, PMID 38437857
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