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 Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Eltrombopag in Platelet Refractory Thrombocytopenia|
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||August 2010|
|Estimated Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
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.
75 mg per day with possible dose escalation to 150 mg per day and 300 mg per day
Please refer to this study by its ClinicalTrials.gov identifier: NCT01194167
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45219|
|Principal Investigator:||Patricia Carey, MD||University of Cincinnati|