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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: An Extension Study of Eltrombopag in Pediatric Patients With Chronic Immune (Idiopathic) Thrombocytopenia Purpura (ITP)

Brief Summary: This is an open-label Phase III extension study to evaluate the long-term safety of eltrombopag in pediatric patients with chronic ITP who previously participated in study TRA115450. This study will allow dosing of eltrombopag at an individualized dose for each subject based upon platelet count. The starting dose will be based on the subject's dose at the end of the TRA115450 study. The maximum dose will be 75 mg daily.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Frequency of all adverse events ( including Ophthalmic events) categorized using CTCAE toxicity grades and clinical laboratory test [ Time Frame: Up to Week 4 Follow-up period ]

Clinical laboratory assessments and frequency of all adverse events, categorized using Common Terminology Criteria for Adverse Events (CTCAE) toxicity grades will present safety and tolerability endpoints


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Novartis

Dates:
Date Received: June 6, 2013
Date Started: June 2013
Date Completion: April 2019
Last Updated: August 8, 2016
Last Verified: August 2016