Clinical Trial: Repeated Exposure to Eltrombopag in Adults With Idiopathic Thrombocytopenic Purpura (REPEAT)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open-label Repeat Dosing Study of Eltrombopag Olamine (SB-497115-GR) in Adult Subjects, With Chronic Idiopathic Thrombocytopenic Purpura (ITP)

Brief Summary:

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.

For more information or to see if you qualify, please visit: http://www.itpstudy.com/gov


Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: 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 ]

Complete blood count, platelet count by blood draw


Original Primary Outcome: Treatment response, assessed by the proportion of patients with platelet counts > or = to 50,000/uL and at least 2x baseline after up to 42 days of dosing for 3 cycles.

Current Secondary Outcome:

  • 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 ]
    CBC, platelet counts
  • Changes in Participants' Platelet Counts During 3 Cycles of Treatment [ Time Frame: Up to 1 year ]
    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 ]
    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 ]
    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) ]
    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) ]
    ITP Bleeding Score: Grade 0 = no bleeding, Grade 1 = mild bleeding, Grade 2 = severe bleeding


Original Secondary Outcome: Safety, symptoms associated with ITP, PD parameters of platelet counts, Clinical laboratory tests, frequency of adverse events,ocular examinations,incidence and severity of bleeding during 3 cycles (up to 10 weeks for each cycle)of intermittent dosing.

Information By: GlaxoSmithKline

Dates:
Date Received: January 17, 2007
Date Started: March 2007
Date Completion:
Last Updated: July 25, 2013
Last Verified: May 2012