A Three-part Study of Eltrombopag in Thrombocytopenic Subjects With Myelodysplastic Syndromes or Acute Myeloid Leukemia

PHASE2CompletedINTERVENTIONAL
Enrollment

162

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

March 31, 2015

Study Completion Date

December 31, 2015

Conditions
Thrombocytopaenia
Interventions
DRUG

eltrombopag

100 mg daily (50 mg for subjects of East Asian heritage), intra-subject dose escalations to a maximum dose of 300 mg (150 mg for subjects of East Asian heritage)

DRUG

placebo

100 mg matching placebo daily (50 mg for subjects of East Asian heritage), intra-subject dose escalations to a maximum dose of 300 mg matching placebo (150 mg for subjects of East Asian heritage)

Trial Locations (120)

7

Novartis Investigative Site, Dublin

8

Novartis Investigative Site, James Street

24

Novartis Investigative Site, Tallaght, Dublin

333

Novartis Investigative Site, Taoyuan

736

Novartis Investigative Site, Tainan County

1000

Novartis Investigative Site, Brussels

1088

Novartis Investigative Site, Budapest

1405

Novartis Investigative Site, Buenos Aires

Novartis Investigative Site, Ciudad Autónoma de Buenos Aires

2060

Novartis Investigative Site, Antwerp

2930

Novartis Investigative Site, Brasschaat

3000

Novartis Investigative Site, Leuven

4012

Novartis Investigative Site, Debrecen

5530

Novartis Investigative Site, Yvoir

6720

Novartis Investigative Site, Szeged

7400

Novartis Investigative Site, Kaposvár

Novartis Investigative Site, Kaposvár

8000

Novartis Investigative Site, Bruges

9000

Novartis Investigative Site, Ghent

10330

Novartis Investigative Site, Bangkok

10400

Novartis Investigative Site, Bangkok

10467

Novartis Investigative Site, The Bronx

10700

Novartis Investigative Site, Bangkok

11527

Novartis Investigative Site, Athens

15100

Novartis Investigative Site, Alessandria

19140

Novartis Investigative Site, Philadelphia

20122

Novartis Investigative Site, Milan

20162

Novartis Investigative Site, Milan

21201

Novartis Investigative Site, Baltimore

25123

Novartis Investigative Site, Brescia

28034

Novartis Investigative Site, Madrid

28223

Novartis Investigative Site, Pozuelo de Alarcón/Madrid

Novartis Investigative Site, Pozuelo de Alarcón/Madrid

29010

Novartis Investigative Site, Málaga

Novartis Investigative Site, Málaga

30912

Novartis Investigative Site, Augusta

31048

Novartis Investigative Site, Haifa

31096

Novartis Investigative Site, Haifa

31203

Novartis Investigative Site, Chihuahua City

32256

Novartis Investigative Site, Jacksonville

32806

Novartis Investigative Site, Orlando

33401

Novartis Investigative Site, West Palm Beach

37007

Novartis Investigative Site, Salamanca

37075

Novartis Investigative Site, Göttingen

39008

Novartis Investigative Site, Santander

40002

Novartis Investigative Site, Khon Kaen

40138

Novartis Investigative Site, Bologna

40225

Novartis Investigative Site, Düsseldorf

49100

Novartis Investigative Site, Petah Tikva

50134

Novartis Investigative Site, Florence

50937

Novartis Investigative Site, Cologne

52621

Novartis Investigative Site, Ramat Gan

53226

Novartis Investigative Site, Milwaukee

57010

Novartis Investigative Site, Thessaloniki

58100

Novartis Investigative Site, Holon

64128

Novartis Investigative Site, Kansas City

64239

Novartis Investigative Site, Tel Aviv

64460

Novartis Investigative Site, Monterrey

Novartis Investigative Site, Monterrey

68000

Novartis Investigative Site, Oaxaca City

68167

Novartis Investigative Site, Mannheim

70199

Novartis Investigative Site, Stuttgart

71201

Novartis Investigative Site, Heraklion, Crete

71913

Novartis Investigative Site, Hot Springs

72401

Novartis Investigative Site, Jonesboro

76100

Novartis Investigative Site, Rehovot

83301

Novartis Investigative Site, Kaohsiung City

84101

Novartis Investigative Site, Beersheba

85016

Novartis Investigative Site, Phoenix

90095

Novartis Investigative Site, Los Angeles

90110

Novartis Investigative Site, Songkhla

91120

Novartis Investigative Site, Jerusalem

94305

Novartis Investigative Site, Stanford

98108

Novartis Investigative Site, Seattle

185019

Novartis Investigative Site, Petrozavodsk

191024

Novartis Investigative Site, St'Petersburg

197341

Novartis Investigative Site, St'Petersburg

603126

Novartis Investigative Site, Nizhny Novgorod

02115

Novartis Investigative Site, Boston

07601

Novartis Investigative Site, Hackensack

08043

Novartis Investigative Site, Voorhees Township

C1431FWO

Novartis Investigative Site, Ciudad Autonoma de Buenos Aires

B1900AXI

Novartis Investigative Site, La Plata

C1025ABH

Novartis Investigative Site, Buenos Aires

74605-020

Novartis Investigative Site, Goiânia - GO

Novartis Investigative Site, Goiânia - GO

81520-060

Novartis Investigative Site, Curitiba

Novartis Investigative Site, Curitiba

90035-903

Novartis Investigative Site, Porto Alegre

14784-400

Novartis Investigative Site, Barretos

Novartis Investigative Site, Barretos

01236030

Novartis Investigative Site, São Paulo

Novartis Investigative Site, São Paulo

20211-030

Novartis Investigative Site, Rio de Janeiro

B3H 2Y9

Novartis Investigative Site, Halifax

M5G 2M9

Novartis Investigative Site, Toronto

H3T 1E2

Novartis Investigative Site, Montreal

625 00

Novartis Investigative Site, Brno

100 34

Novartis Investigative Site, Prague

128 08

Novartis Investigative Site, Prague

128 20

Novartis Investigative Site, Prague

01307

Novartis Investigative Site, Dresden

45 500

Novartis Investigative Site, Ioannina

Unknown

Novartis Investigative Site, Chai Wan

Novartis Investigative Site, Shatin, New Territories

Novartis Investigative Site, Cork

Novartis Investigative Site, Limerick

Novartis Investigative Site, Tullamore

Novartis Investigative Site, Granada

CP 14080

Novartis Investigative Site, Mexico City

1081 HV

Novartis Investigative Site, Amsterdam

41-500

Novartis Investigative Site, Chorzów

87-100

Novartis Investigative Site, Torun

02-097

Novartis Investigative Site, Warsaw

00927

Novartis Investigative Site, San Juan

197 089

Novartis Investigative Site, Saint Petersburg

519-809

Novartis Investigative Site, Hwasun

110-744

Novartis Investigative Site, Seoul

120-752

Novartis Investigative Site, Seoul

08036

Novartis Investigative Site, Barcelona

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY