Repeated Exposure to Eltrombopag in Adults With Idiopathic Thrombocytopenic Purpura (REPEAT)
This open-label, repeat dosing study, TRA108057, will evaluate the efficacy, safety and tolerability of eltrombopag, when administered in a repeat, cyclic dosing schedule. The study will describe the effect of repeated (3 cycles), intermittent dosing of eltrombopag on the pharmacodynamics and durability of eltrombopag response as measured by the peripheral platelet counts.
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Chronic Idiopathic Thrombocytopenic Purpura
Purpura, Thrombocytopenic, Idiopathic
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label Repeat Dosing Study of Eltrombopag Olamine (SB-497115-GR) in Adult Subjects, With Chronic Idiopathic Thrombocytopenic Purpura (ITP)|
- Number of Participants Who Responded (Platelet Count >=50 Gi/L and >=2x Baseline) to Eltrombopag Treatment in Cycle 2 or Cycle 3 Given Participants Responded in Cycle 1 [ Time Frame: Day 42 of each cycle ] [ Designated as safety issue: No ]Complete blood count, platelet count by blood draw
- Number of Participants Who Responded (Platelet Count Greater Than or Equal to 50 Gi/L and at Least 2x Baseline) for at Least 80 Percent of Their On-therapy Assessments During Weeks 2-6. [ Time Frame: Up to 42 days of dosing ] [ Designated as safety issue: No ]CBC, platelet counts
- Changes in Participants' Platelet Counts During 3 Cycles of Treatment [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]Changes from baseline, during on-therapy periods of a cycle, during off-therapy periods of a cycle, and within 4 weeks of permanent discontinuation of eltrombopag treatment.
- Number of Participants Who Required Rescue Medication [ Time Frame: Up to 3 cycles of treatment including follow-up visits following last dose of eltrombopag ] [ Designated as safety issue: No ]New idiopathic thrombocytopenic purpura (ITP) medication, increase dose of a concomitant ITP medication from baseline, platelet transfusion, and/or splenectomy
- Change in Participants Anti-platelet Antibody Levels From Baseline Through Follow-up [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]Change in participants' anti-platelet antibody levels was measured as the number of samples positive for at least 1 glycoprotein from baseline to follow-up. Serum glycoprotein-specific antigens: GPIIb/IIIa, Ib/IX, and Ia/IIa
- Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale [ Time Frame: Baseline, on-treatment visits (Weeks 1-6), off-treatment visits (Weeks 1-4) ] [ Designated as safety issue: No ]World health Organization (WHO) Bleeding Scale Grade 0 = no bleeding, Grade 1 = petechiae, Grade 2 = mild blood loss, Grade 3 = gross blood loss, Grade 4 = debilitating blood loss.
- Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score [ Time Frame: Baseline, on-treatment visits (Weeks 1-6), off-treatment visits (Weeks 1-4) ] [ Designated as safety issue: No ]ITP Bleeding Score: Grade 0 = no bleeding, Grade 1 = mild bleeding, Grade 2 = severe bleeding
|Study Start Date:||March 2007|
|Study Completion Date:||November 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
Other Name: eltrombopag
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|Study Director:||GSK Clinical Trials||GlaxoSmithKline|