Study of Eltrombopag in Platelet Refractory Thrombocytopenia

November 21, 2019 updated by: University of Cincinnati

A Phase II Study of Eltrombopag in Platelet Refractory Thrombocytopenia

This phase II trial is studying the effects of the drug eltrombopag has on thrombocytopenia (low platelet count). Eltrombopag is approved by the FDA for the treatment of thrombocytopenia (low platelet count) in adults who have had an insufficient response to medications such as corticosteroids and immunoglobulins. Eltrombopag is not approved by the FDA (Food and Drug Administration) for the treatment of thrombocytopenia refractory to platelet transfusion and so for this study is considered investigational.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Laboratory diagnosis of platelet refractoriness
  • Diagnosis of platelet dependence
  • Adequate liver and renal laboratory screening tests

Exclusion Criteria:

  • Patients with thrombocytopenia that are responsive to platelet therapy
  • Patients actively receiving intravenous immunoglobulin, plasmapheresis or cytotoxic medications for thrombocytopenia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Eltrombopag
Eltrombopag 75 mg per day. Possible escalation to 150 mg per day after day 15 lab results. Possible escalation to 300 mg per day after day 29 lab results.
Drug: Eltrombopag
75 mg per day with possible dose escalation to 150 mg per day and 300 mg per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the likelihood of eltrombopag allowing platelet transfusion independence in patients with platelet refractoriness at doses of 75 mg, 150 mg, and 300 mg per day
Time Frame: 3 years average
3 years average

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Patricia Carey, MD, University of Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

August 25, 2010

First Submitted That Met QC Criteria

September 1, 2010

First Posted (ESTIMATE)

September 2, 2010

Study Record Updates

Last Update Posted (ACTUAL)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCC-H1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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