TABLE 4.
Hemostats in active clinical trials.
| Generic name (code name a ) | Condition | Active ingredient | Route | NCT number [phase] | Sponsor |
|---|---|---|---|---|---|
| Cell/gene therapy | |||||
| CD68‐ET3‐LV CD34+ | Hemophilia A | Autologous HSCs: transduced with LV encoding FVIII | IV | NCT04418414 [1] | Expression Therapeutics |
| HSCT CD68‐ET3‐LV | Hemophilia A | Autologous HSCs: transduced with LV encoding FVIII | IV | NCT05265767 [1] | Christian Medical College, Vellore |
| (SPK‐8016) | Hemophilia A | AAV | IV | NCT03734588 [1/2] | Spark Therapeutics |
| Giroctocogene fitelparovec (PF‐07055480) | Hemophilia A | AAV 2/6 encoding FVIII | IV | NCT03061201 [2] | Pfizer |
| Giroctocogene fitelparovec (PF‐07055480) | Hemophilia A | AAV 2/6 encoding FVIII | IV | NCT04370054 [3] | Pfizer |
| (ZS802) | Hemophilia A | AAV encoding FVIII | IV | NCT05523128 [N/A] | Institute of Hematology & Blood Diseases Hospital, China |
| (GS001) | Hemophilia A | AAV encoding FVIII | IV | NCT04728841 [N/A] | Institute of Hematology & Blood Diseases Hospital, China |
| BAY2599023 (DTX201) | Hemophilia A | AAV encoding FVIII | IV | NCT03588299 [1/2] | Bayer |
| (ASC618) | Hemophilia A | AAV encoding FVIII | IV | NCT04676048 [1/2] | ASC Therapeutics |
| (AAV2/8‐HLP‐FVIII‐V3) | Hemophilia A | AAV8 encoding FVIII | IV | NCT03001830 [1] | University College, London |
| (BAX 888) | Hemophilia A | AAV8 encoding FVIII | IV | NCT03370172 [1/2] | Baxalta, Takeda |
| (SPK‐8011) | Hemophilia A | AV‐LK03 (Spark200) encoding FVII | IV | NCT03003533 [1/2] | Spark Therapeutics |
| (VGB‐R04) | Hemophilia B | AAV encoding FIX | IV | NCT05152732 [1 b ] | Institute of Hematology & Blood Diseases Hospital, China |
| (BBM‐H901) | Hemophilia B | AAV encoding FIX | IV | NCT04135300 [N/A] | Institute of Hematology & Blood Diseases Hospital, China |
| (ZS801) | Hemophilia B | AAV encoding FIX | IV | NCT05630651 [N/A] | Institute of Hematology & Blood Diseases Hospital, China |
| (BBM‐H901) | Hemophilia B | AAV encoding FIX | IV | NCT05709288 [1] | Institute of Hematology & Blood Diseases Hospital, China |
| (VGB‐R04) | Hemophilia B | AAV encoding FIX | IV | NCT05441553 [1/2] | Shanghai Vitalgen BioPharma Co. |
| (ZS801) | Hemophilia B | AAV encoding FIX | IV | NCT05641610 [1/2] | Institute of Hematology & Blood Diseases Hospital, China |
| Fidanacogene elaparvovec (PF‐06838435 (formerly SPK‐9001)) | Hemophilia B | AAV encoding FIX | IV | NCT03307980 [2] | Pfizer |
| Fidanacogene elaparvovec (PF‐06838435 (formerly SPK‐9001)) | Hemophilia B | AAV encoding FIX | IV | NCT03861273 [3] | Pfizer |
| (BBM‐H901) | Hemophilia B | AAV encoding FIX | IV | NCT05203679 [3] | Shanghai Belief‐Delivery BioMed Co. |
| scAAV2/8‐LP1‐hFIXco | Hemophilia B | AAV2/8 encoding FIX | IV | NCT00979238 [1] | St. Jude Children's Research Hospital |
| AskBio009 (BAX 335) | Hemophilia B | AAV8 encoding FIX | IV | NCT01687608 [1/2] | Takeda |
| Fitusiran | Hemophilia A and B | siRNA | IV | NCT03754790 [3] | Sanofi |
| Fitusiran | Hemophilia A and B | siRNA | IV | NCT05662319 [3] | Sanofi |
| Miscellaneous | |||||
| Chinese herbal medicine (FYTF‐919) | ICH | Miscellaneous (herbs) | Oral | NCT05066620 [3] | Guangzhou University of Traditional Chinese Medicine |
| Arista | Surgery | Miscellaneous (plant starch) | Topical | NCT05522153 [1] | Virtua Health |
| PuraBond | Surgery | Miscellaneous (Peptides self‐assembling into ECM mimicking scaffold) | N/A | NCT05773781 [N/A] | University of Liverpool |
| Proteins | |||||
| NNC0365‐3769 (Mim8) | Hemophilia A | FVIII mimetic bispecific antibody | SC | NCT05306418 [3] | Novo Nordisk |
| NNC0365‐3769 (Mim8) | Hemophilia A | FVIII mimetic bispecific antibody | SC | NCT05053139 [3] | Novo Nordisk |
| NNC0365‐3769 (Mim8) | Hemophilia A | FVIII mimetic bispecific antibody | SC | NCT05685238 [3] | Novo Nordisk |
| NNC0365‐3769 (Mim8) | Hemophilia A | FVIII mimetic bispecific antibody | SC | NCT05878938 [3] | Novo Nordisk |
| (NXT007) | Hemophilia A | FVIII mimetic bispecific antibody | SC | NCT05987449 [1/2] | Hoffmann‐La Roche |
| Concizumab | Hemophilia A and B | Anti‐TFPI monoclonal antibody | SC | NCT05135559 [3] | Novo Nordisk |
| Concizumab | Hemophilia A and B | Anti‐TFPI monoclonal antibody | SC | NCT04083781 [3] | Novo Nordisk |
| Concizumab | Hemophilia A and B | Anti‐TFPI monoclonal antibody | SC | NCT04082429 [3] | Novo Nordisk |
| (MG1113) | Hemophilia A and B | Anti‐TFPI monoclonal antibody | SC | NCT05493631 [1] | GC Biopharma |
| (KN057) | Hemophilia A and B | Anti‐TFPI monoclonal antibody | SC | NCT05421429 [2] | Suzhou Alphamab |
| Marstacimab (PF‐06741086) | Hemophilia A and B | Anti‐TFPI monoclonal antibody | SC | NCT03938792 [3] | Pfizer |
| Marstacimab (PF‐06741086) | Hemophilia A and B | Anti‐TFPI monoclonal antibody | SC | NCT05145127 [3] | Pfizer |
| Marstacimab (PF‐06741086) | Hemophilia A and B | Anti‐TFPI monoclonal antibody | SC | NCT05611801 [3] | Pfizer |
| (TU7710) | Hemophilia A and B | Bypassing agent | IV | NCT06025552 [1] | TiumBio |
| (SS109) | Hemophilia A and B | Factor VIIa‐Fc Fusion Protein | IV | NCT06010953 [1/2] | Jiangsu Gensciences |
| Recombinant FVIIa | Hemophilia A and B | FVII | IV | NCT05487976 [3] | Chia Tai Tianqing Pharmaceutical Group |
| Recombinant Factor VIIa (LR769) | Hemophilia A and B | FVIIa | IV | NCT05695391 [3] | Laboratoire francais de Fractionnement et de Biotechnologies |
| (STSP‐0601) | Hemophilia A and B | FX activator | IV | NCT05619926 [2] | Staidson Biopharmaceuticals |
| SerpinPC | Hemophilia A and B | Novel inhibitor of APC | IV or SC | NCT04073498 [1/2] | ApcinteX Ltd |
| SerpinPC | Hemophilia A and B | Novel inhibitor of APC | SC | NCT05789524 [2] | ApcinteX Ltd |
| SerpinPC | Hemophilia B | Novel inhibitor of APC | SC | NCT05789537 [2] | ApcinteX Ltd |
| Fibrinogen | Major Hemorrhage | Fibrinogen (FI) | IV | NCT05300672 [3] | Azienda Usl di Bologna |
| Fibrinogen concentrate human | Major Hemorrhage | Fibrinogen (FI) | IV | NCT05091684 [2] | Centre Hospitalier Universitaire de Saint Etienne |
| Bentracimab (PB2452) | Major Hemorrhage | Monoclonal antibody | IV | NCT04286438 [3] | PhaseBio Pharmaceuticals |
| 4 factor prothrombin complex concentrates | Major Hemorrhage | PCC | IV | NCT05738642 [N/A] | Second Affiliated Hospital, Zhejiang University |
| sFilm‐FS | Surgery | Fibrin Sealant | Topical | NCT04660721 [1/2] | Sealantium Medical |
| (BT524) | Surgery | Fibrinogen | IV | NCT03444324 [3] | Biotest |
| (TAK‐330) | Surgery | PCC | IV | NCT05156983 [3] | Takeda |
| Small molecules | |||||
| Tranexamic acid | Antepartum hemorrhage | TXA | IV, oral | NCT05840471 [N/A] | Hawler Medical University |
| Tranexamic acid | ICH | TXA | IV | NCT04742205 [1 b ] | Kathmandu Medical College and Teaching Hospital |
| Terlipressin | Major Hemorrhage | Terlipressin | IV | NCT06027970 [3] | Postgraduate Institute of Medical Education and Research |
| Tranexamic acid | Major Hemorrhage | TXA | IV | NCT04387305 [3] | Daniel Nishijima, University of California, Davis |
| Tranexamic acid | Major Hemorrhage | TXA | IM | NCT04521881 [3] | London School of Hygiene and Tropical Medicine |
| Tranexamic acid | Major Hemorrhage | TXA | IV | NCT05053867 [3] | M.D. Anderson Cancer Center |
| Tranexamic acid | Postpartum Hemorrhage | TXA | IV | NCT03069859 [2] | Sunnybrook Health Sciences Centre |
| Tranexamic acid | Postpartum Hemorrhage | TXA | IV | NCT05370820 [2] | George Washington University |
| Tranexamic acid | Postpartum Hemorrhage | TXA | IV | NCT05811676 [3] | Guangzhou Medical University |
| Tranexamic acid | Postpartum Hemorrhage | TXA | IV | NCT05759156 [N/A] | Dow University of Health Sciences |
| Tranexamic acid | Postpartum Hemorrhage | TXA | Topical | NCT05072873 [N/A] | Aswan University Hospital |
| Tranexamic acid | Postpartum Hemorrhage | TXA | IV | NCT04304625 [3] | University Hospital, Bordeaux |
| Tranexamic acid | Surgery | TXA | N/A | NCT05507983 [3] | Maasstad Hospital |
| Tranexamic acid | Surgery | TXA | IV | NCT04311073 [3] | Eastern Virginia Medical School |
| Tranexamic acid | Surgery | TXA | IV | NCT05427513 [1 b ] | Shaukat Khanum Memorial Cancer Hospital & Research Centre |
| Tranexamic acid | Surgery | TXA | IV | NCT05230381 [N/A] | Beijing Tiantan Hospital |
| Tranexamic acid | Surgery | TXA | SC | NCT06057675 [2] | Vanderbilt University Medical Center |
| Tranexamic acid | Surgery | TXA | IV | NCT05774717 [1] | Vanderbilt University Medical Center |
| Tranexamic acid | Surgery | TXA | Topical | NCT05152186 [3] | Minia University |
Abbreviations: AAV, adeno‐associated virus; APC, activated protein C; ECM, extra‐cellular matrix; HSC, hematopoietic stem cells; ICH, intracerebral hemorrhage; LV, lentiviral vectors; PCC, prothrombin complex concentrate; SC, subcutaneous; siRNA, small interfering RNA; TFPI, tissue‐factor pathway inhibitor; TXA, tranexamic acid.
a
Code name mentioned wherever applicable.
b
Early Phase 1 trial.