Conditions: Chronic Idiopathic Thrombocytopenic Purpura Purpura, Thrombocytopenic, Idiopathic
Keywords: thrombopoietin, immunosuppressive therapy, eltrombopag, idiopathic thrombocytopenic purpura, blood platelet, splenectomy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 23
Healthy volunteers: no

Brief summary:
This is a Phase II/III multicenter study comprising of the double-blind, followed by open-label phases to evaluate and compare the efficacy and tolerability of eltrombopag (SB-497115-GR) in chronic ITP patients

Detailed description:

Arms:
arm 1: Subject will initiate treatment with SB-497115-GR 12.5mg once a day. Based on the subjects platelet count at each visit, the dose of SB-497115-GR may be adjusted at 12.5mg, 25mg or 50mg. arm 2: Subject will initiate treatment with SB-497115-GR 12.5mg matching placebo once a day. Based on the subjects platelet count at each visit, the dose of SB-497115-GR 12.5mg matching placebo may be increased to 2 tablet of SB-497115-GR 12.5mg matching placebo.

Interventions: intervention 1: SB-497115-GR 12.5mg intervention 2: SB-497115-GR 25mg intervention 3: SB-497115-GR 12.5mg matching placebo intervention 4: SB-497115-GR 50 mg
Intervention descriptions: intervention 1: SB-497115-GR 12.5mg tablet once a day intervention 2: SB-497115-GR 25mg tablet once a day intervention 3: SB-497115-GR 12.5mg matching placebo x1 or 2 tablet once a day intervention 4: SB-497115-GR 25mg tablet x2 once a day

Protocol document: