CLINICAL TRIALS PROFILE FOR ELTROMBOPAG OLAMINE

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/μL will be investigated.
NCT00351468 ↗	EXTEND (Eltrombopag Extended Dosing Study)	Completed	Novartis Pharmaceuticals	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/μL 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

Clinical Trial Conditions for Eltrombopag Olamine

Condition Name

Condition Name for Eltrombopag Olamine
Intervention	Trials
Purpura, Thrombocytopaenic, Idiopathic	5
Adult Acute Megakaryoblastic Leukemia (M7)	2
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)	2
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)	2

Condition MeSH

Condition MeSH for Eltrombopag Olamine
Intervention	Trials
Purpura, Thrombocytopenic, Idiopathic	7
Thrombocytopenia	6
Purpura, Thrombocytopenic	6
Purpura	6

Clinical Trial Locations for Eltrombopag Olamine

Trials by Country

Trials by Country for Eltrombopag Olamine
Location	Trials
United States	90
Germany	34
Italy	31
Canada	16
China	14

Trials by US State

Trials by US State for Eltrombopag Olamine
Location	Trials
New York	8
Georgia	6
Texas	6
Virginia	5
Missouri	4

Clinical Trial Progress for Eltrombopag Olamine

Clinical Trial Phase

Clinical Trial Phase for Eltrombopag Olamine
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	3
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Eltrombopag Olamine
Clinical Trial Phase	Trials
Completed	9
Active, not recruiting	3
Terminated	2

Clinical Trial Sponsors for Eltrombopag Olamine

Sponsor Name

Sponsor Name for Eltrombopag Olamine
Sponsor	Trials
GlaxoSmithKline	7
National Cancer Institute (NCI)	5
Novartis Pharmaceuticals	4

Sponsor Type

Sponsor Type for Eltrombopag Olamine
Sponsor	Trials
Other	23
Industry	14
NIH	5