Purpura, Thrombocytopaenic, Idiopathic Clinical Trial
Official title:
A Longitudinal 2-year Bone Marrow Study of Eltrombopag Olamine (SB-497115-GR) in Previously Treated Adults, With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
A open-label, multi-center 2-year safety study to ascertain the baseline levels of bone marrow fibers in previously treated adults with chronic immune (idiopathic) thrombocytopenic purpura (ITP) and to evaluate the long-term effect of eltrombopag on bone marrow fibers. The study will also describe the long-term safety and tolerability of oral eltrombopag treatment in subjects with chronic ITP.
This is a phase IV, open-label safety study, designed to determine baseline levels of bone
marrow fibers in previously treated adults with chronic immune (idiopathic) thrombocytopenic
purpura (ITP)and to evaluate the long-term effect of eltrombopag on bone marrow reticulin
and/or collagen fibers.
The duration of the screening period is up to 8 weeks. Eltrombopag will be administered for
at least 2-years followed by a 4-week follow-up period. Bone marrow biopsies will be
performed at screening, after 1-year and 2-years of eltrombopag treatment, and at early
withdrawal of treatment. The screening bone marrow biopsy should be performed within 8 weeks
of planned start of study medication and the bone marrow biopsy block must be available for
central laboratory processing.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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