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Study of Eltrombopag in Platelet Refractory Thrombocytopenia

This study has been withdrawn prior to enrollment.
(Inability to identify eligible patients)
Information provided by (Responsible Party):
University of Cincinnati Identifier:
First received: August 25, 2010
Last updated: January 8, 2012
Last verified: January 2012
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.

Condition Intervention Phase
Drug: Eltrombopag
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Eltrombopag in Platelet Refractory Thrombocytopenia

Resource links provided by NLM:

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: August 2010
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01194167

United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
University of Cincinnati
Principal Investigator: Patricia Carey, MD University of Cincinnati
  More Information

Responsible Party: University of Cincinnati Identifier: NCT01194167     History of Changes
Other Study ID Numbers: UCC-H1
Study First Received: August 25, 2010
Last Updated: January 8, 2012

Keywords provided by University of Cincinnati:
Platelet refractory thrombocytopenia

Additional relevant MeSH terms:
Blood Platelet Disorders
Hematologic Diseases processed this record on April 28, 2017