Safety and Efficacy Study of Romiplostim to Treat Immune Thrombocytopenia (ITP) in Pediatric Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

February 28, 2015

Study Completion Date

February 28, 2015

Conditions
Idiopathic Thrombocytopenic PurpuraThrombocytopeniaThrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)Thrombocytopenic PurpuraImmune Thrombocytopenia
Interventions
DRUG

Romiplostim

The starting dose of romiplostim is 1 µg/kg administered weekly by subcutaneous injection. Participants will return to the clinic weekly to provide platelet counts and undergo dose titrations under the supervision of the treating physician. Weekly dose increases will continue in increments of 1 µg/kg up to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10\^9/L. Dose adjustment will be allowed during the treatment period to maintain a platelet count between ≥ 50 x 10\^9/L and ≤ 200 x 10\^9/L.

DRUG

Placebo

Matching placebo administered by subcutaneous injection

Trial Locations (33)

2031

Research Site, Randwick

3052

Research Site, Parkville

4029

Research Site, Herston

10016

Research Site, New York

10021

Research Site, New York

15224

Research Site, Pittsburgh

19104

Research Site, Philadelphia

20010

Research Site, Washington D.C.

30322

Research Site, Atlanta

37232

Research Site, Nashville

40202

Research Site, Louisville

43205

Research Site, Columbus

45229

Research Site, Cincinnati

46260

Research Site, Indianapolis

48201

Research Site, Detroit

52242

Research Site, Iowa City

54601

Research Site, La Crosse

60611

Research Site, Chicago

61615

Research Site, Peoria

64108

Research Site, Kansas City

68114

Research Site, Omaha

70118

Research Site, New Orleans

76104

Research Site, Fort Worth

77030

Research Site, Houston

89109

Research Site, Las Vegas

92123

Research Site, San Diego

92868

Research Site, Orange

08901

Research Site, New Brunswick

L8S 4K1

Research Site, Hamilton

M5G 1X8

Research Site, Toronto

H3H 1P3

Research Site, Montreal

H3T 1C5

Research Site, Montreal

G1V 4G2

Research Site, Québec

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY