At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
Thrombosomesbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I, Multi-Center, Open-Label, Dose Escalation Study of Thrombosomes® in Bleeding Thrombocytopenic Patients in Three Cohorts
In Brief
A Phase 1 clinical trial evaluating Thrombosomes for Thrombocytopenia and 2 related conditions. Completed, enrolled 24 participants across 7 sites in 2 countries.
Detailed Summary
The study evaluates the safety and potential early signals of efficacy of allogeneic Thrombosomes in bleeding thrombocytopenic patients
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThrombocytopenia, Hematologic Diseases, Bone Marrow Aplasia
CountriesNorway, United States
CollaboratorsDepartment of Health and Human Services
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedJan 2018
Enrollment StartMar 2018
Primary CompletionAug 2019
Study CompletionSep 2019
TodayJul 2026
First PostedJan 9, 2018
Enrollment StartMar 19, 2018
Primary CompletionAug 1, 2019
Study CompletionSep 25, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 8.5 years ago
Interventions
Thrombosomesbiological
Freeze-dried platelets