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Thrombosomes® in Bleeding Thrombocytopenic Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Thrombosomes® in Bleeding Thrombocytopenic Patients

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

NCT03394755•Cellphire Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 74 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adults up to 74 y/o with any of following: acute leukemia (ALL or AML), myelodysplasia, aplasia, and/or therapy (chemotherapy or radiation) induced bone marrow aplasia or hypoplasia with thrombocytopenia (platelet count ≥ 5,000 and ≤ 70,000/μL) for a minimum of 2 days. May include bone marrow transplant or peripheral or cord blood stem cell recipients, but not subjects with Graft-vs-Host disease.
•Hospitalized patients (or willing to be hospitalized for 24 hours after Rx) with Modified WHO Grade 1 (subset) or Grade 2 Bleeding Score or at risk for same within 4 weeks of screening. The Grade 1 subset includes patients who have either epistaxis, hematuria, oral petechiae, or bleeding at invasive or other wound sites.
•No platelet inhibitor drugs within 5 days prior to infusion and through Day 6 follow-up period.

Exclusion Criteria

•History or condition related to thrombosis, embolism or vascular occlusion/ischemia, including but not limited to: transient ischemic attack, stroke, myocardial infarction, stent placement, valve replacement and/or repair
•Currently with an active acute infection, or suspected infection, a single oral temperature of ≥ 101° F or a temperature of ≥ 100.4°F sustained over a 1 h period in past 24 h. Subjects on prophylactic antibiotics are not excluded from study
•Coagulopathy or receiving anticoagulants that result in PT (prothrombin time) or aPTT (activated partial thromboplastin time) values greater than 1.3 X upper limit of normal or elevated D-dimer of decreased fibrinogen
•History of any inherited coagulation or platelet function, disorder or ITP (idiopathic thrombocytopenic purpura), TTP (thrombotic thrombocytopenic purpura), or HUS (hemolytic-uremic syndrome)
•Receipt of tranexamic acid or other antifibrinolytics within 48 hrs prior to infusion
•Treatment with an investigational drug within 1 month of infusion, other than for treatment of their underlying disease

Locations (7)

City of Hope

Duarte, California, United States

Georgetown University Hospital

Washington D.C., District of Columbia, United States

University of Michigan

Ann Arbor, Michigan, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Hoxworth Blood Center/University of Cincinnati

Cincinnati, Ohio, United States

MD Anderson Cancer Center

Houston, Texas, United States

Haukeland University Hospital

Bergen, Norway

Key Dates

Start Date

March 19, 2018

Primary Completion Date

August 1, 2019

Completion Date

September 25, 2019

Last Updated

April 14, 2023

Enrollment

ACTUAL participants

Conditions

ThrombocytopeniaHematologic DiseasesBone Marrow Aplasia

Interventions

Thrombosomes

BIOLOGICAL

Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders

NCT07104565

Immune Thrombocytopenia

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RECRUITINGPHASE3

A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

NCT06533098

Thrombocytopenia, Neonatal Alloimmune

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RECRUITINGPHASE2

Daratumumab Versus Rituximab in the Management of Pediatric Primary Immune Thrombocytopenia (ITP)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 14, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Thrombosomes® in Bleeding Thrombocytopenic Patients

Inclusion Criteria

Exclusion Criteria

Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders

A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Daratumumab Versus Rituximab in the Management of Pediatric Primary Immune Thrombocytopenia (ITP)

Anti-CD38 Monoclonal Antibody Combined With Rituximab in the Management of Primary Immune Thrombocytopenia (ITP)

A Study of DZD8586 in Adults With Primary Immune Thrombocytopenia (ITP) (TAI-SHAN11)

A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia