drugset / Trial / NCT04631211
Thrombosomes® in Bleeding Thrombocytopenic Patients Study
Phase 2
Terminated
21 enrolled
Cellphire Therapeutics, Inc.
Department of Health and Human Services · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This prospective, multicenter, randomized, open-label, Phase 2, parallel, dose ranging, multidose trial will enroll patients into 3 Thrombosomes dose groups and 1 control liquid stored platelets (LSP) group in order to evaluate, in a dose-escalation manner, the safety, and impact on bleeding, and the preliminary effect on coagulation measures of increasing doses of allogeneic Thrombosomes in comparison to standard of care, LSP.
Timeline
- Start
- 2021-03-05
- Primary completion
- 2022-01-07
- Completion
- 2022-01-07
Outcome
Outcome not reported
Stopped (Business): “This study was terminated due to loss of funding for this indication from the Biomedical Advanced Research and Development Authority (BARDA) in November 2022.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Liquid Stored Platelets (LSP) | Unknown | — | — |
| Subject | Thrombosomes | Other / unclassified | — | — |