Eltrombopag for Post Transplant Thrombocytopenia
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|ClinicalTrials.gov Identifier: NCT01000051|
Recruitment Status : Active, not recruiting
First Posted : October 22, 2009
Last Update Posted : April 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Thrombocytopenia||Drug: Eltrombopag Drug: Placebo||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Eltrombopag for Post Transplant Thrombocytopenia|
|Actual Study Start Date :||February 2010|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||February 2019|
Starting dose 50 mg/day orally for 8 weeks
Starting daily dose 50 mg orally on empty stomach (1 hour before or 2 hours after a meal) for 8 weeks. East Asians start at 25 mg daily.
Other Name: Promacta
Placebo Comparator: Placebo
Once a day orally for 8 weeks
Once a day, orally for 8 weeks.
- Number of Participants with Platelet Count >/= 50 X 10^9/l at day 57 without platelet transfusion [ Time Frame: Baseline to Day 57 ]Development of a platelet count >/= 30 X 10^9/l at day 57 without platelet transfusion within 7 days, and participants who drop out of the trial before completion of day 57 with a platelet count >/= 30 X 10^9/l at the time of discontinuation are considered successes with respect to outcome (primary endpoint).
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): NCT01000051
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Uday Popat, MD||M.D. Anderson Cancer Center|