40 completed, 6 unknown, 5 terminated, 4 recruiting. 16 Phase 3, 15 Phase 4, 8 Phase 2, 4 Phase 1, 3 Not applicable.
Follow Factor IX: new trials by email Literature Review of Factor IX trials Research Report on Factor IX
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 |
|---|---|---|---|---|---|---|
| Very Low-volume Plasma Exchange in ACLF Double Plasma Molecular Adsorption System (DPMAS), Low-volume plasma exchange, Prothrombin Complex Concentrate (PCC) - Acute on Chronic Liver Failure (ACLF) | Not applicable | Not yet recruiting | Third Affiliated Hospital, Sun Yat-Sen University | 840 | 2026-10-01 | 2026-10-05 |
| Prothrombin Complex Concentrate vs Fresh Frozen Plasma in Goal-directed Bleeding Management in Cardiac Surgery fresh frozen plasma, prothrombin complex concentrate - Cardiac Valve Disease | Phase 4 | Recruiting | Konkuk University Medical Center | 100 | 2026-03-27 | 2026-06-17 |
| Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB) BE1116, FFP - Complex Cardiovascular Surgery With Cardiopulmonary Bypass | Phase 3 | Recruiting | CSL Behring | 200 | 2025-09-15 | 2026-10-15 |
| Fibrinogen Concentrates Versus Cryoprecipitate in Liver Transplant Surgery fresh frozen plasma, prothrombin complex concentrate - Liver Diseases | Phase 4 | Not yet recruiting | Konkuk University Medical Center | 92 | 2025-09-01 | 2025-07-20 |
| Prothrombin Complex Concentrate vs Fresh Frozen Plasma in Goal-directed Bleeding Management in Non-cardiac Surgery fresh frozen plasma, prothrombin complex concentrate - Prostate Cancer, Spine, Open | Phase 4 | Unknown | Konkuk University Medical Center | 154 | 2024-03-01 | 2024-01-02 |
| Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery Prothrombin Complex Concentrate, Human, Fresh Frozen Plasma - Valvular Heart Surgery | Phase 4 | Terminated | SHI Jia | 476 | 2023-10-25 | 2026-06-24 |
| An Observational Cohort Study to Characterize the Effectiveness and Safety of HEMGENIX® in Patients With Hemophilia B HEMGENIX, Factor IX (FIX) - Hemophilia B | Recruiting | CSL Behring | 500 | 2023-06-15 | 2026-02-19 | |
| Coagulation in Cirrhosis Platelet Concentrate, Prothrombin Complex Concentrate, Restricitve Use - Liver Cirrhosis | Phase 4 | Recruiting | Medical University of Vienna | 400 | 2023-01-19 | 2025-01-14 |
| Andexanet Alfa and 4F-PCC Use in Patients Hospitalised With an Anticoagulant-related Major Bleed Andexanet alfa, 4F-PCC - Anticoagulant-related Major Bleed | Completed | AstraZeneca | 5480 | 2022-09-15 | 2023-11-28 | |
| Factor IX as Adjunctive Therapy to Emicizumab (EMIX) Factor IX - Hemophilia A | Early Phase 1 | Completed | Tulane University | 12 | 2022-08-01 | 2025-01-20 |
| Prehospital Kcentra for Hemorrhagic Shock Prothrombin Complex Concentrate, Human, Placebo - Trauma Injury | Phase 2 | Unknown | Oregon Health and Science University | 166 | 2021-03-15 | 2023-12-15 |
| Liberal or Adhere to Recommendations for PCC Management in Major Bleeding Following Trauma Prothrombin Complex Concentrate - Traumatic Bleeding | Not applicable | Unknown | Second Affiliated Hospital, Zhejiang University, School of Medicine | 650 | 2021-01-01 | 2024-10-04 |
| A Study to Assess the Reversal of the Anticoagulant Effects of Milvexian by 4-Factor Prothrombin Complex Concentrate (4F-PCC) (Part 1) and Recombinant Human Factor VIIa (rFVIIa) (Part 2) in Healthy Participants Milvexian, 4-Factor Prothrombin Complex Concentrate (4F-PCC), Recombinant Human Factor VIIa (rFVIIa) - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 52 | 2020-07-27 | 2025-08-15 |
| ZEPLAST- PED: ZEro_PLASma Trial in Small Infants Undergoing Cardiac Surgery Fibrinogen Concentrate Human, Prothrombin Complex Concentrate, Fresh Frozen Plasma - Bleeding, Cardiac Defect | Phase 2 | Terminated | IRCCS Policlinico S. Donato | 40 | 2020-02-27 | 2021-11-03 |
| Nonacog Alfa Prophylaxis And Treatment Of Bleeding Episodes In Previously Treated Patients With Hemophilia B Nonacog alfa - Hemophilia B | Phase 4 | Completed | Pfizer | 25 | 2020-02-10 | 2022-07-01 |
| REPlaCE- Randomized Trial Evaluating the Use of Prothrombin Complex concEntrate to Improve Survival in Patients With Traumatic Coagulopathy Prothrombin Complex Concentrate, Whole Blood, Plasma, Packed Red Blood Cells - Coagulopathy, Hemorrhage | Phase 2 | Unknown | Bellal A. Joseph, MD, FACS | 280 | 2020-01-01 | 2019-06-10 |
| Factor Replacement in Surgery Prothrombin Complex Concentrate, Frozen Plasma - Bleeding in Cardiac Surgery | Phase 2 | Unknown | University Health Network, Toronto | 103 | 2019-09-24 | 2020-11-03 |
| Trial of PCC Versus FFP in Patients Undergoing Heart Surgery Prothrombin Complex Concentrate (PCC), Fresh Frozen Plasma - Bleeding, Surgery | Phase 2 | Completed | Queen Mary University of London | 50 | 2019-03-01 | 2020-11-17 |
| RIXUBIS PMS India (RIXUBIS PMS) RIXUBIS: On-Demand, RIXUBIS: Prophylaxis - Hemophilia B | Phase 4 | Completed | Baxalta now part of Shire | 25 | 2018-12-07 | 2022-08-30 |
| Administration of Prothrombin Complex Concentrate vs. Standard Transfusion During/After Heart Transplantation Kcentra, Frozen Plasma Product, Human - Heart Disease End Stage, Heart Failure，Congestive | Phase 3 | Terminated | University of Maryland, Baltimore | 14 | 2018-07-11 | 2025-05-23 |
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Hemophilia B (31) · Hemorrhage (8) · Hemophilia A (4) · Hemostatic Disorders (4) · Intracranial Hemorrhages (3) · Blood Loss, Surgical (2) · Liver Diseases (2) · Thrombosis (2) · Wounds and Injuries (2) · Accidental Injuries (1) · Acute-On-Chronic Liver Failure (1) · Afibrinogenemia (1) · Arrhythmias, Cardiac (1) · Blood Coagulation Disorders (1) · Coagulation Protein Disorders (1)
Pfizer (8) · CSL Behring (7) · Baxalta now part of Shire (6) · Konkuk University Medical Center (3) · Bioverativ Therapeutics Inc. (2) · Octapharma (2) · Wyeth is now a wholly owned subsidiary of Pfizer (2) · AstraZeneca (1) · Bellal A. Joseph, MD, FACS (1) · Emory University (1) · Fondation Ophtalmologique Adolphe de Rothschild (1) · Grifols Biologicals, LLC (1) · Heidelberg University (1) · IRCCS Policlinico S. Donato (1) · ISU Abxis Co., Ltd. (1)
United States (19) · Germany (7) · United Kingdom (7) · Austria (6) · China (6) · Japan (6) · Netherlands (6) · Poland (6) · South Korea (6) · Canada (5) · France (5) · Bulgaria (4) · India (4) · Italy (4) · Russia (4)
Alan S. Go, MD (1) · Bellal Joseph, MD (1) · Campbell McMillan (1) · ChurWoo You, PhD (1) · E P Mauser-Bunschoten, MD, PdD (1) · Gregory Nuttall, MD (1) · Ingrid Pabinger-Fasching, Prof. (1) · J. Edson (1) · Jack Lazerson (1)
PMID 36408876, PMID 40750723, PMID 26196195, PMID 36848635, PMID 37870112, PMID 17938794, PMID 18208533, PMID 19787352, PMID 22764744, PMID 22776196, PMID 23834666, PMID 24286226, PMID 24304002, PMID 24418368, PMID 27302126, PMID 28159192, PMID 28457980, PMID 28833808, PMID 28847867, PMID 31815658, PMID 33462764, PMID 33631774, PMID 33792729, PMID 34032739, PMID 35144945, PMID 35767271, PMID 36066598, PMID 36812434, PMID 37341915, PMID 37753225, PMID 38437857, PMID 39088218, PMID 39341368, PMID 39524040, PMID 39633218, PMID 39935281, PMID 41358585, PMID 42243996, PMID 42440100
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