NCT07315373
Optimal Dose of Zanubrutinib to Treat Adult Immune Thrombocytopenia
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Record History
All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗
Notable Phase changed: Phase 1 → Phase 2 Show 6 more changesShow less
- Enrollment increased: 60 → 90 participants
- Start date: Dec 25, 2025 to Dec 1, 2026
- Eligibility criteria expanded, about 13 words
- Interventions modified
- Secondary endpoints: details revised at 1 of 8 entries
- Collaborators expanded, about 117 words
- Study First Submitted
- Notable: the plan changed
Endpoints
Primary
Secondary (8)
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Arms and interventions
Participants in this arm will receive a combination therapy consisting of: Zanubrutinib: 80 mg taken orally once daily for 26 weeks. Dexamethasone: 40 mg taken orally once daily for 4 consecutive days at the beginning of treatment. A second identical 4-day course may be repeated after 2 weeks if an adequate initial platelet response is not achieved.
Participants in this arm will receive a combination therapy consisting of: Zanubrutinib: 160 mg taken orally once daily for 26 weeks. Dexamethasone: 40 mg taken orally once daily for 4 consecutive days at the beginning of treatment. A second identical 4-day course may be repeated after 2 weeks if an adequate initial platelet response is not achieved.
Participants in this arm will receive a therapy : Dexamethasone: 40 mg taken orally once daily for 4 consecutive days at the beginning of treatment. A second identical 4-day course may be repeated after 2 weeks if an adequate initial platelet response is not achieved.
Drugs: Zanubrutinib 80mg/d, High dose dexamethasone, Zanubrutinib 160mg/d