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Study of Eltrombopag in Platelet Refractory Thrombocytopenia

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ClinicalTrials.gov Identifier: NCT01194167
Recruitment Status : Withdrawn (Inability to identify eligible patients)
First Posted : September 2, 2010
Last Update Posted : January 10, 2012
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Cincinnati

Brief Summary:
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 or disease Intervention/treatment Phase
Thrombocytopenia Drug: Eltrombopag Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Eltrombopag in Platelet Refractory Thrombocytopenia
Study Start Date : August 2010
Estimated Primary Completion Date : August 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Eltrombopag

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




Primary Outcome Measures :
  1. 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 ]


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01194167


Locations
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
University of Cincinnati
GlaxoSmithKline
Investigators
Principal Investigator: Patricia Carey, MD University of Cincinnati

Responsible Party: University of Cincinnati
ClinicalTrials.gov Identifier: NCT01194167     History of Changes
Other Study ID Numbers: UCC-H1
First Posted: September 2, 2010    Key Record Dates
Last Update Posted: January 10, 2012
Last Verified: January 2012

Keywords provided by University of Cincinnati:
Platelet refractory thrombocytopenia

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases