3 completed, 2 withdrawn, 1 recruiting. 6 Phase 3, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 6 | Completed 3, Withdrawn 2, Recruiting 1 |
| Phase 2 | 1 | Completed 1 |
Follow Afibrinogenemia: new trials by email Literature Review of Afibrinogenemia trials Research Report on Afibrinogenemia
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 |
|---|---|---|---|---|---|---|
| Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery CSL511 Fibrinogen concentrate (human), Cryoprecipitate - Acquired Fibrinogen Deficiency | Phase 3 | Recruiting | CSL Behring | 90 | 2024-10-01 | 2026-10-13 |
| FIB Grifols Congenital Deficiency for On-demand Treatment and Surgical Prophylaxis FIB Grifols - Congenital Afibrinogenemia, Hypofibrinogenemia | Phase 3 | Withdrawn | Instituto Grifols, S.A. | 2023-12-01 | 2023-10-23 | |
| Adjusted Fibrinogen Replacement Strategy BT524, FFP/Cryo - Bleeding Disorder, Hypofibrinogenemia; Acquired | Phase 3 | Completed | Biotest | 222 | 2018-04-03 | 2025-06-13 |
| Human Fibrinogen Concentrate (FGTW) in Pediatric Patients With Congenital Fibrinogen Deficiency biological: human fibrinogen concentrate - Hypofibrinogenemia, Congenital, Afibrinogenemia, Congenital | Phase 2 / Phase 3 | Completed | Laboratoire français de Fractionnement et de Biotechnologies | 16 | 2014-01-01 | 2016-02-12 |
| Pharmacokinetic, Efficacy and Safety of BT524 in Patients With Congenital Fibrinogen Deficiency BT524 (Part I), BT524 (Part II) - Congenital Afibrinogenemia, Congenital Hypofibrinogenemia | Phase 3 | Completed | Biotest | 67 | 2013-03-01 | 2025-07-03 |
| Fibrinogen Concentrate (Human) - Efficacy and Safety Study Fibrinogen Concentrate, Human (FCH), Cryoprecipitate - Afibrinogenemia, Hypofibrinogenemia | Phase 3 | Withdrawn | CSL Behring | 2009-10-01 | 2023-02-06 |
Blood Coagulation Disorders (1) · Hemorrhage (1) · Hemostatic Disorders (1) · Pseudomyxoma Peritonei (1)
Blood Coagulation Disorders, Inherited (6) · Coagulation Protein Disorders (6) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (6) · Genetic Diseases, Inborn (6) · Hematologic Diseases (6) · Hemic and Lymphatic Diseases (6) · Hemorrhagic Disorders (6) · Blood Coagulation Disorders (5) · Adenocarcinoma (1) · Adenocarcinoma, Mucinous (1) · Carcinoma (1) · Cardiovascular Diseases (1) · Neoplasms (1) · Neoplasms by Histologic Type (1) · Neoplasms, Cystic, Mucinous, and Serous (1)
cryoprecipitate coagulum (3) · Fibrinogen (2)
Biotest (2) · CSL Behring (2) · Instituto Grifols, S.A. (1) · Laboratoire français de Fractionnement et de Biotechnologies (1)
Germany (2) · Lebanon (2) · United Kingdom (2) · Belgium (1) · Bulgaria (1) · Czechia (1) · Egypt (1) · France (1) · Morocco (1) · Poland (1) · Spain (1) · Switzerland (1) · Tunisia (1) · Turkey (Türkiye) (1)
Claudia Djambas Khayat, MD (1) · Niels Rahe-Meyer, Prof. (1)
PMID 40741224, PMID 41702298, PMID 42247815
2017 (1), 2018 (1)