NCT03394755

Thrombosomes® in Bleeding Thrombocytopenic Patients

A Phase I, Multi-Center, Open-Label, Dose Escalation Study of Thrombosomes® in Bleeding Thrombocytopenic Patients in Three Cohorts

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Cellphire Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The study evaluates the safety and potential early signals of efficacy of allogeneic Thrombosomes in bleeding thrombocytopenic patients

Detailed description

The primary objective of the present study was to assess the safety of increasing dose levels of Thrombosomes in bleeding patients with thrombocytopenia. The secondary objective was to explore early signals of clinical efficacy of Thrombosomes in this population. The secondary objectives included: 1) Evaluation of the impact on WHO (World Health Organization) bleeding scores at various timepoints; 2) number and type of blood products infused through day 6 follow-up period; and 3) post hoc analysis of hematology, coagulation, and chemistry.

Conditions

• Thrombocytopenia
• Hematologic Diseases
• Bone Marrow Aplasia

Interventions

Type	Name	Description
BIOLOGICAL	Thrombosomes	Freeze-dried platelets

Timeline

• Start date: 2018-03-19
• Primary completion: 2019-08-01
• Completion: 2019-09-25
• First posted: 2018-01-09
• Last updated: 2023-04-14
• Results posted: 2023-04-14

Locations

7 sites across 2 countries: United States, Norway

Regulatory

• FDA-regulated drug study