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Generated: December 17, 2018

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CLINICAL TRIALS PROFILE FOR ELTROMBOPAG OLAMINE

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Clinical Trials for Eltrombopag Olamine

Trial ID Title Status Sponsor Phase Summary
NCT00351468 EXTEND (Eltrombopag Extended Dosing Study) Completed Novartis Phase 3 An open-label, dose-adjustment, extension study to evaluate the safety and efficacy of eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who have previously been enrolled in an eltrombopag trial. This study will allow adjustment of the eltrombopag dose to achieve an individualized dose and schedule for each subject. In addition, the ability to reduce the dose of concomitant ITP medications in the presence of eltrombopag, while maintaining platelet counts = 50,000/microL will be investigated.
NCT00370331 RAISE: Randomized Placebo-Controlled Idiopathic Thrombocytopenic Purpura (ITP) Study With Eltrombopag Completed GlaxoSmithKline Phase 3 The rationale for this Phase III study is to evaluate the 6 month safety and efficacy of eltrombopag in the treatment of previously treated subjects with chronic ITP. The starting dose of eltrombopag, 50 mg, once daily was selected based upon the observed efficacy, safety and pharmacokinetics in a dose-finding Study (TRA100773). This Phase III study is a randomized, double-blind, placebo-controlled, Phase III study, to evaluate efficacy, safety and tolerability of eltrombopag, initially administered as 50 mg oral tablets once daily for six months in adult subjects with previously treated chronic ITP. Subjects will be randomized 2:1, eltrombopag to placebo, and will be stratified based upon splenectomy status, use of ITP medication at baseline and baseline platelet count less than or equal to 15,000/µL. Subjects will receive study medication for 6 months, during which the dose of study medication may be adjusted based upon individual platelet counts. In addition, subjects may taper off concomitant ITP medications and may receive any rescue treatments as dictated by local standard of care. After discontinuation of study medication, subjects will complete follow-up visits at weeks 1, 2, 4 and months 3 and 6.
NCT00424177 Repeated Exposure to Eltrombopag in Adults With Idiopathic Thrombocytopenic Purpura (REPEAT) Completed GlaxoSmithKline Phase 2 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
NCT00643929 LENS - Long-term Eltrombopag Observational Study Completed GlaxoSmithKline N/A A long term observational ocular safety study in adults who have received study medication (either active drug or placebo) in a phase II or III clinical study evaluating eltrombopag. The study will follow subjects for 2.5 years following their last ocular assessment on their prior treatment study (regardless of the therapeutic indication) and will describe long-term ocular safety with respect to changes in the lenses over time from all subjects.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Eltrombopag Olamine

Condition Name

Condition Name for Eltrombopag Olamine
Intervention Trials
Purpura, Thrombocytopaenic, Idiopathic 4
Purpura, Thrombocytopenic, Idiopathic 2
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) 2
Adult Acute Basophilic Leukemia 2
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Condition MeSH

Condition MeSH for Eltrombopag Olamine
Intervention Trials
Purpura, Thrombocytopenic 6
Purpura 6
Purpura, Thrombocytopenic, Idiopathic 6
Preleukemia 4
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Clinical Trial Locations for Eltrombopag Olamine

Trials by Country

Trials by Country for Eltrombopag Olamine
Location Trials
United States 85
Germany 32
Italy 29
Canada 14
United Kingdom 10
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Trials by US State

Trials by US State for Eltrombopag Olamine
Location Trials
New York 8
Georgia 6
Virginia 5
Missouri 4
Washington 4
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Clinical Trial Progress for Eltrombopag Olamine

Clinical Trial Phase

Clinical Trial Phase for Eltrombopag Olamine
Clinical Trial Phase Trials
Phase 4 1
Phase 3 3
Phase 2 5
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Clinical Trial Status

Clinical Trial Status for Eltrombopag Olamine
Clinical Trial Phase Trials
Completed 7
Recruiting 2
Terminated 2
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Clinical Trial Sponsors for Eltrombopag Olamine

Sponsor Name

Sponsor Name for Eltrombopag Olamine
Sponsor Trials
GlaxoSmithKline 7
National Cancer Institute (NCI) 3
Novartis 2
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Sponsor Type

Sponsor Type for Eltrombopag Olamine
Sponsor Trials
Industry 9
Other 4
NIH 3
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Serving hundreds of leading biopharmaceutical companies globally:

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