A Phase 2 Study of Thrombosomes® in Bleeding Patients with Thrombocytopenia

Status

Active, Recruiting

NATIONAL TRIAL REFERENCE NUMBER

Purpose

This objective of this trial is to evaluate the safety and efficacy of infusing multiple dose levels (3 doses) in a parallel, repeat dose study of Thrombosomes in 160 volunteers who are thrombocytopenic bleeding patients.

Thrombosomes are lyophilized (freeze-dried) activated platelets prepared by pooling platelets that meet FDA requirements collected from pools of 5-10 volunteer blood donors. Unlike standard liquid stored platelets that can only be stored for 5-7 days after collection, Thrombosomes can be stored for up to 3 years and are reconstituted in minutes by adding sterile water for injection.  Learn more about Thrombosomes.

About the Trial

This is a Phase 2 dose-ranging study of Thrombosomes vs. standard liquid stored platelets in bleeding patients with thrombocytopenia due to primary bone marrow disorders or chemotherapy, immunotherapy radiation therapy, and/or refractory response to fresh platelet concentrate transfusion with or without splenomegaly (enlarged spleen).

Dates

Estimated Study Start Date
April 2021

Estimated Primary Completion Date
May 2022

Estimated Study Completion Date
October 2022

Eligibility

Only a qualified healthcare professional can determine your eligibility. However, this information may be useful in talking with your doctor.

Age
Adults, 18 or older

Gender
All

Condition
Thrombocytopenia

Trial Sites

Trial sites will be added as they are recruited.

  • Helse Bergen Haukeland University Hospital (Norway)
  • MedStar Georgetown University Hospital
  • MD Anderson Cancer Center
  • Rambam Medical Center (Israel)
Next steps

If you think you might be eligible and are interested in this study, please talk to your doctor.

Participating in a clinical trial is an important decision. Anyone participating in a trial should know as much as possible about what is being studied, what risks are involved, and what potential benefits may be gained before deciding to enroll.

Find out more in our Clinical Trials FAQ

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