A Long-term Safety Study of Eltrombopag in Pediatric Patients With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

PHASE3CompletedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

June 18, 2013

Primary Completion Date

July 4, 2017

Study Completion Date

July 4, 2017

Conditions
Purpura, Thrombocytopenic, Idiopathic
Interventions
DRUG

Eltrombopag Tablets

Eltrombopag tablets will be white, round film coated tablets containing eltrombopag olamine equivalent to 12.5 mg, 25 mg, 50 mg and 75 mg of eltrombopag. The 12.5 mg tablet will be smaller than the 25 mg, 50 mg and 75 mg tablets. Subjects will receive maximum dose of 75 mg once daily (QD).

DRUG

Eltrombopag PfOS

Eltrombopag PfOS is a reddish-brown to yellow powder contained inside an elongated sachet. Each sachet will contain eltrombopag olamine equivalent to 20 mg of eltrombopag per gram of powder. Subjects will receive maximum dose of 75 mg once daily (QD)

Trial Locations (3)

117997

Novartis Investigative Site, Moscow

198205

Novartis Investigative Site, Saint Petersburg

350007

Novartis Investigative Site, Krasnodar

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY