Trials / Terminated
TerminatedNCT04631211
Thrombosomes® in Bleeding Thrombocytopenic Patients Study
A Prospective, Multicenter, Randomized, Open-Label Phase 2, Parallel, Dose Ranging Multidose Study of Thrombosomes® vs Liquid Stored Platelets (LSP) in Bleeding Thrombocytopenic Patients
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Cellphire Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Thrombocytopenia
- Hematologic Malignancy
- Bone Marrow Aplasia
- Myeloproliferative Disorders
- Myelodysplastic Syndromes
- Platelet Refractoriness
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Thrombosomes | Human platelet derived lyophilized hemostatic |
| BIOLOGICAL | Liquid Stored Platelets (LSP) | Leukocyte reduced apheresis platelets or whole blood derived pooled platelet concentrate equivalent (4-6 units) |
Timeline
- Start date
- 2021-03-05
- Primary completion
- 2022-01-07
- Completion
- 2022-01-07
- First posted
- 2020-11-17
- Last updated
- 2023-05-25
Locations
6 sites across 3 countries: United States, Israel, Norway
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04631211. Inclusion in this directory is not an endorsement.