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Thrombosomes® in Bleeding Thrombocytopenic Patients Study

NCT04631211 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2023-05-25

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Terry Gernsheimer, MD · University of Washington

  • Mike Fitzpatrick, PhD · Cellphire Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-05
Primary Completion
2022-01-07
Completion
2022-01-07
FDA Drug
Yes

Countries

  • United States
  • Israel
  • Norway

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04631211 on ClinicalTrials.gov