Back to resultsStudy of Eltrombopag in Platelet Refractory Thrombocytopenia
Primary Purpose
Thrombocytopenia
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Eltrombopag
Sponsored by
About this trial
This is an interventional treatment trial for Thrombocytopenia focused on measuring Platelet refractory thrombocytopenia
Eligibility 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
Sites / Locations
- University of Cincinnati
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Eltrombopag
Arm Description
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.
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01194167
First Posted
August 25, 2010
Last Updated
November 21, 2019
Sponsor
University of Cincinnati
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT01194167
Brief Title
Study of Eltrombopag in Platelet Refractory Thrombocytopenia
Official Title
A Phase II Study of Eltrombopag in Platelet Refractory Thrombocytopenia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Inability to identify eligible patients
Study Start Date
August 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Cincinnati
Collaborators
GlaxoSmithKline
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombocytopenia
Keywords
Platelet refractory thrombocytopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eltrombopag
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Eltrombopag
Intervention Description
75 mg per day with possible dose escalation to 150 mg per day and 300 mg per day
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Carey, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Eltrombopag in Platelet Refractory Thrombocytopenia
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