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NCT05369364
The Combination of Zanubrutinib and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia
Phase 2 trial testing Zanubrutinib in Immune Thrombocytopenia in 150 participants. Not yet recruiting.
30 December 2025
Quick facts
| Lead sponsor | Peking University People's Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 1 June 2022 |
| Primary completion | 30 December 2025 |
| Estimated completion | 1 June 2026 |
Drugs / interventions tested
- Zanubrutinib (ZANUBRUTINIB) — full drug profile →
- Dexamethasone (dexamethasone) — full drug profile →
Conditions studied
- Immune Thrombocytopenia — all drugs for Immune Thrombocytopenia →
Sponsor
Peking University People's Hospital
Who can join
Adults 18 to 70, any sex, with Immune Thrombocytopenia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Randomized, open-label, multicenter study to compare the efficacy and safety of zanubrutinib plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with primary immune thrombocytopenia (ITP).
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Safety and Efficacy of Tyrosine Kinase Inhibitors in Immune Thrombocytopenic Purpura: A Systematic Review of Clinical Trials.
Ali MA, Anwar MY, Aiman W, Dhanesar G, et al · · 2023 · cited 13× · PMID 36810430 · DOI 10.3390/jox13010005 -
A Case Series and Literature Review on Zanubrutinib Therapy for the Treatment of Relapsed/Refractory Immune Thrombocytopenia.
Ding B, Li M, Liu L, Song X, et al · · 2025 · cited 4× · PMID 39973148 · DOI 10.1002/cnr2.70152 -
Rilzabrutinib for the Treatment of Immune Thrombocytopenia.
Labanca C, Martino EA, Vigna E, Bruzzese A, et al · · 2025 · cited 3× · PMID 40222822 · DOI 10.1111/ejh.14425
Verify or expand the search:
- PubMed search for NCT05369364
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Zanubrutinib
Trials testing the same drug.
- NCT07341191 — Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR · Phase 2 · not yet recruiting
- NCT06859008 — Zanubrutinib in Combination With Sonrotoclax for the Treatment of Underrepresented Ethnic and Racial Minorities With Rel · Phase 1 · recruiting
- NCT07377578 — A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cel · Phase 3 · recruiting
- NCT07321652 — Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for Previously Untreated C · Phase 3 · not yet recruiting
- NCT07283965 — Zanubrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies · not yet recruiting
Other recruiting trials for Immune Thrombocytopenia
Currently open trials in the same condition.
- NCT07104565 — Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Diso · Phase 2 · recruiting
- NCT07007962 — Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed · Phase 3 · recruiting
- NCT07216079 — Rilzabrutinib for the Adult Participants With Chronic ITP Who Have Completed Phase 3 Study in Japan · Phase 3 · active not recruiting
- NCT06776510 — A Clinical Study of NAD in the Treatment of Immune Thrombocytopenia · Phase 1, PHASE2 · recruiting
- NCT06715215 — Role of Acute Phase Proteins In Diagnosis of Immune Thrombocytopenia · NA · recruiting
Other Peking University People's Hospital trials
Trials by the same sponsor.
- NCT07535645 — Baricitinib for Post-HSCT Persistent Thrombocytopenia · Phase 1, PHASE2 · not yet recruiting
- NCT07516002 — Immunoglobulin Efficacy and Immune Profiling in Antibody Immunodeficiency · not yet recruiting
- NCT07294339 — A Randomized Controlled Trial of Acupuncture for the Management of Hot Flashes in Patients With Hormone Receptor-Positiv · NA · not yet recruiting
- NCT07500441 — Digital PCR of CHIP and MR for MRD Monitoring After Allo-HSCT in AML · recruiting
- NCT07487883 — Cadherin 3(CDH3)-Targeted PET in Lung Malignant Tumors · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05369364 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Peking University People's Hospital
- Last refreshed: 11 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05369364.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing