This study is a phase 3 study where eligible patients will be randomized 1:1 to one of two treatment strategies: receiving a thrombopoietin receptor agonist (Avatrombopag), or anti-CD20 (Rituximab).
This is a multi-center, international, open label randomized, controlled pragmatic trial consisting of 3 phases: 1. First phase extends from randomization to week 28 2. Second phase extends from week 28 to 78 3. Third phase extends from week 78 to the end of the trial (i.e. the last patient completing week 78)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
Daily tablets
I.V.
Efficacy of the oral TPO-RA, Avatrombopag, to Rituximab
To compare the efficacy of the oral TPO-RA, Avatrombopag to Rituximab by measuring the rates of durable responses defined as achieving platelet counts ≥ 50 X109/L in ≥3 of the bi-weekly measurements between weeks 20 and 28 including the last count without having received any other platelet elevating agents after randomization apart from rescue therapy received before end of week 10.
Time frame: Assessed at week 28
The changes in the disease specific HRQoL
The changes in the disease specific HRQoL from baseline to weeks 28 and 78 measured by ITP-PAQ (Overall Quality of Life Scale) score.
Time frame: Baseline to weeks 28 and weeks 78
Changes in the level of fatigue
The changes in the level of fatigue from baseline to weeks 28 and 78 measured by FACIT-Fatigue score
Time frame: Baseline to weeks 28 and weeks 78
Rates of Sustained Response Off-Treatment (SROT)
The rates of Sustained Response Off-Treatment (SROT) at 78 weeks where the occurrence of SROT defined as * A platelet count \> 50 X109/L in at least 3 of the 4 planned visits between weeks 36 and 78 including week 78 * No administration of platelet elevating agent between weeks 36 and 78.
Time frame: At 78 weeks
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