Conditions: Purpura, Thrombocytopaenic, Idiopathic
Keywords: Immune (idiopathic) thrombocytopenic purpura (ITP) bone marrow fibers eltrombopag olamine thrombopoietin receptor agonist
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 167
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Oral eltrombopag once daily, starting dose 50 mg (or 25 mg for subjects of East Asian ancestry).

Interventions: intervention 1: Eltrombopag olamine
Intervention descriptions: intervention 1: Thrombopoietin receptor agonist

Protocol document: