10 completed, 2 terminated, 1 recruiting, 1 unknown. 6 Phase 3, 5 Phase 4, 2 Phase 1, 2 Phase 2, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 6 | Completed 5, Terminated 1 |
| Phase 4 | 5 | Completed 2, Recruiting 1, Terminated 1, Withdrawn 1 |
| Phase 1 | 2 | Completed 2 |
| Phase 2 | 2 | Completed 1, Unknown 1 |
| Not applicable | 1 | Completed 1 |
Follow prothrombin complex concentrates: new trials by email Literature Review of prothrombin complex concentrates trials Research Report on prothrombin complex concentrates
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 |
|---|---|---|---|---|---|---|
| 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 |
| Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery Octaplex, Frozen Plasma Product, Human - Bleeding Cardiac Surgery Patients | Phase 3 | Completed | Octapharma | 420 | 2022-11-30 | 2025-08-15 |
| Dose-Response in PD and Safety of Cofact Under VKA Anticoagulation Cofact - Healthy Volunteers | Phase 1 / Phase 2 | Completed | Prothya Biosolutions | 69 | 2021-11-12 | 2024-04-08 |
| Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor Octaplex - Acute Major Bleeding | Phase 3 | Terminated | Octapharma | 100 | 2021-09-01 | 2026-06-25 |
| Factor In the Initial Resuscitation of Severe Trauma 2 Patients Fibrinogen + PCC, Frozen Plasma - Traumatic Hemorrhage, Coagulopathy | Phase 4 | Terminated | University Health Network, Toronto | 142 | 2021-04-01 | 2026-10-21 |
| 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 |
| Patient Blood Management for Massive Obstetric Hemorrhage Thromboelastometry, Standard Coagulation Test, Fibrinogen Concentrate Human - Post Partum Hemorrhage, Fibrinogenolysis; Hemorrhage | Not applicable | Completed | Angel Augusto Perez Calatayud | 100 | 2018-11-01 | 2021-06-08 |
| A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients Without Inhibitors fitusiran, factor concentrates - Hemophilia A, Hemophilia B | Phase 3 | Completed | Genzyme, a Sanofi Company | 120 | 2018-03-01 | 2022-03-28 |
| Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcentra) for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk. Octaplex, Beriplex P/N (Kcentra) - Significant Bleeding Risk | Phase 3 | Completed | Octapharma | 208 | 2017-06-08 | 2023-03-08 |
| Strategy of Transfusion in Trauma Patients - STATA Trial Blood Products only, Point of Care guided - Wounds and Injuries | Phase 4 | Completed | University of Sao Paulo General Hospital | 156 | 2014-07-01 | 2016-11-02 |
| A Study to Assess the Effects of 2 Prothrombin Complex Concentrates on the Pharmacodynamics of Apixaban in Healthy Adult Subjects Apixaban, Cofact (4-Factor PCC), Beriplex P/N (4-Factor PCC) - Anticoagulation | Phase 1 | Completed | Bristol-Myers Squibb | 43 | 2014-02-01 | 2015-08-13 |
| PCC and Fibrinogen Compared With FFP in PPH PCC, FFP - Postpartum Haemorrhage | Phase 4 | Withdrawn | Helsinki University Central Hospital | 2013-07-01 | 2018-10-10 | |
| The ZEro PLASma Trial (ZEPLAST): Avoidance of Fresh Frozen Plasma in Cardiac Surgery Fibrinogen, Saline solution, Prothrombin complex - Heart Disease | Phase 3 | Completed | IRCCS Policlinico S. Donato | 119 | 2011-11-01 | 2015-03-31 |
| IMMUNINE Pre-Treatment Study Factor IX Concentrate (purified, virus-inactivated) - Hemophilia B | Phase 4 | Completed | Baxalta now part of Shire | 57 | 2010-05-31 | 2021-04-23 |
| Study of Octaplex (Human Prothrombin Complex Concentrate) and Fresh Frozen Plasma in Patients Under Vitamin K Therapy Antagonist Needing Urgent Surgery or Invasive Procedures Octaplex (human prothrombin complex concentrate), Fresh frozen plasma - Reversal of Anticoagulant Treatment | Phase 3 | Completed | Octapharma | 200 | 2008-05-01 | 2023-01-31 |
Hemophilia B (6) · Postpartum Hemorrhage (2) · Wounds and Injuries (2) · Blood Coagulation Disorders (1) · Blood Coagulation Disorders, Inherited (1) · Coagulation Protein Disorders (1) · Disseminated Intravascular Coagulation (1) · Genetic Diseases, Inborn (1) · Genetic Diseases, X-Linked (1) · Heart Diseases (1) · Hematologic Diseases (1) · Hemophilia A (1) · Hemorrhagic Disorders (1) · Hemostatic Disorders (1) · Liver Cirrhosis (1)
Octapharma (4) · University Health Network, Toronto (2) · Angel Augusto Perez Calatayud (1) · Baxalta now part of Shire (1) · Bristol-Myers Squibb (1) · Genzyme, a Sanofi Company (1) · Helsinki University Central Hospital (1) · IRCCS Policlinico S. Donato (1) · Medical University of Vienna (1) · Prothya Biosolutions (1) · University of Sao Paulo General Hospital (1)
United States (5) · Ukraine (4) · Canada (3) · Germany (3) · Italy (3) · Poland (3) · Spain (3) · Austria (2) · Brazil (2) · Bulgaria (2) · France (2) · Georgia (2) · Romania (2) · Russia (2) · Turkey (Türkiye) (2)
Angel Augusto Perez Calatayud, M.D. (1) · Jouni V. Ahonen, Ph.D., M.D. (1) · Keyvan Karkouti, MD (1) · Luis T Da Luz, MD (1) · Marco Ranucci, MD (1) · Roseny R Rodrigues, M.D. (1) · Salah Hadi, MD (1) · Thomas Bodewes, MD (1) · Wolfgang Frenzel (1) · Wolfgang Frenzel, MD (1)
PMID 26037084, PMID 26591047, PMID 33792729, PMID 34479938, PMID 34922648, PMID 36408876, PMID 37003278, PMID 39088218, PMID 39174056, PMID 40156829, PMID 40271704, PMID 40982282, PMID 42404094
2009 (1), 2016 (1)