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Last Updated: July 16, 2020

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CLINICAL TRIALS PROFILE FOR ELTROMBOPAG OLAMINE

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All Clinical Trials for Eltrombopag Olamine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00351468 EXTEND (Eltrombopag Extended Dosing Study) Completed Novartis Phase 3 2006-06-01 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 2006-11-01 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 2007-03-01 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 2007-02-01 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.
NCT00903422 Eltrombopag Treatment of Thrombocytopenia in Subjects With Advanced Myelodysplastic Syndrome (MDS) or Secondary Acute Myeloid Leukemia After MDS (sAML/MDS) Completed GlaxoSmithKline Phase 1 2009-05-01 This study will evaluate the safety and tolerability of eltrombopag in the treatment of low platelet counts in adult subjects with advanced myelodysplastic syndrome (MDS), secondary acute myeloid leukemia after MDS (sAML/MDS), or de novo AML that are relapsed, refractory or ineligible to receive azacitidine, decitabine, intensive chemotherapy or autologous/allogeneic stem cell transplantation. This is a placebo-controlled study in which patients will receive study medication daily for 6 months, during which time the dose of study medication may be adjusted based upon individual platelet counts and bone marrow blast counts. All subjects will receive best standard of care (platelet transfusions, mild chemotherapy, cytokines, valproic acid, all-trans retinoic acid, ESAs or G-CSF) in addition to study medication. Subjects taking placebo may be allowed to crossover to eltrombopag treatment if a clinically and statistically significant improvement in bone marrow blast counts is seen in subjects treated with eltrombopag.
NCT01098487 A Longitudinal 2-year Bone Marrow Study of Eltrombopag in Previously Treated Adults, With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Completed GlaxoSmithKline Phase 4 2010-05-01 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.
NCT01147809 Safety and Efficacy Study for Solid Tumor Patients Treated With Eltrombopag Completed GlaxoSmithKline Phase 2 2010-06-01 The present study is a randomized, blinded, placebo-controlled, two-Phase, sequential cohort, dose finding study to assess the safety and efficacy of eltrombopag in patients with solid tumors receiving gemcitabine monotherapy or the combination of gemcitabine plus carboplatin or cisplatin. Phase I of the study will examine safety and tolerability of various doses of eltrombopag to identify a dose and schedule of eltrombopag. Phase II will confirm that the chosen dose and schedule of eltrombopag from Phase I can deliver clinically meaningful benefit(s) to thrombocytopenic patients by improving platelet numbers.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Eltrombopag Olamine

Condition Name

Condition Name for Eltrombopag Olamine
Intervention Trials
Purpura, Thrombocytopaenic, Idiopathic 4
Adult Acute Basophilic Leukemia 2
Adult Acute Myeloblastic Leukemia With Maturation (M2) 2
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) 2
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Condition MeSH

Condition MeSH for Eltrombopag Olamine
Intervention Trials
Purpura, Thrombocytopenic, Idiopathic 6
Purpura, Thrombocytopenic 6
Purpura 6
Thrombocytopenia 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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