Conditions: Purpura, Thrombocytopaenic, Idiopathic
Keywords: eltrombopag olamine SB-497115-GR idiopathic thrombocytopenic purpura thrombocytopenia ITP platelets
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 302
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Open-label eltrombopag

Interventions: intervention 1: eltrombopag olamine (SB-497115-GR)
Intervention descriptions: intervention 1: Eltrombopag with starting dose of 50mg daily, max dose of 75mg daily and min dose of 25mg daily or less frequently. Modifications were given to maintain platelet count in range of 50 to 200 Gi/L.

Protocol document: