The Holistic Study
- Sponsor
- Ostfold Hospital Trust
- Study ID
- NCT07051915
- Phase
- PHASE3
- Status
- Not Yet Recruiting
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Conditions
- Thrombocytopenia Purpura
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Avatrombopag — DRUGDaily tablets
- Rituximab (Arm B) — DRUGI.V.
Study Details
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).
Key Dates
- Start date
- Sep 15, 2025
- Status verified
- Sep 2025
- Primary completion
- Jan 31, 2028
- Completion
- Dec 31, 2029
Study Design
- Enrollment
- 220 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: AvatrombopagOpen label, oral Avatrombopag 20 mg tablets taken daily during the first week. Dose tapering period commencing from week 28 for up to 8 weeks.
- Active Comparator: RituximabOpen label, intravenous infusions of 1000mg Rituximab 2 weeks apart
Primary Outcome Measure
Efficacy of the oral TPO-RA, Avatrombopag, to Rituximab [ Time Frame: Assessed at week 28 ]