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NCT03838354
A Clinical Trial of Chidamide in the Management of Refractory ITP
Phase 1, PHASE2 trial testing Chidamide in Thrombocytopenia in 61 participants. Completed in 1 September 2023.
1 September 2022
Quick facts
| Lead sponsor | Shandong University |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 61 |
| Start date | 1 June 2021 |
| Primary completion | 1 September 2022 |
| Estimated completion | 1 September 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
Conditions studied
- Thrombocytopenia — all drugs for Thrombocytopenia →
Sponsor
Shandong University
Who can join
18 and older, any sex, with Thrombocytopenia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Primary immune thrombocytopenia (ITP) is an autoimmune bleeding disorder. Increased macrophage phagocytosis of antibody-coated platelet as well as decreased number and/or impaired function of CD4+CD25+Foxp3+ regulatory T (Treg) cells have been shown to participate in the pathogenesis of ITP. Our preclinical data revealed that chidamide, a histone deacetylase inhibitor (HDACi), could attenuate macrophage phagocytosis of antibody-coated platelets, stimulate production of natural Foxp3+ Tregs, and upregulate CTLA4 expression through modulation of histone H3K27 acetylation. The project was undertaking by Qilu Hospital of Shandong University in China. In order to evaluate the efficacy and safety of chidamide at two different dosage regimens in adult patients with refractory ITP.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Therapeutic potential of tucidinostat, a subtype-selective HDAC inhibitor, in cancer treatment.
Sun Y, Hong JH, Ning Z, Pan D, et al · · 2022 · cited 58× · PMID 36120308 · DOI 10.3389/fphar.2022.932914 -
Current Understanding of Immune Thrombocytopenia: A Review of Pathogenesis and Treatment Options.
Mititelu A, Onisâi MC, Roșca A, Vlădăreanu AM. · · 2024 · cited 44× · PMID 38396839 · DOI 10.3390/ijms25042163 -
Emerging Therapies in Immune Thrombocytopenia.
Audia S, Bonnotte B, Bonnotte B. · · 2021 · cited 44× · PMID 33801294 · DOI 10.3390/jcm10051004 -
Current therapeutic strategies and perspectives in refractory ITP: What have we learned recently?
Lv Y, Shi H, Liu H, Zhou L. · · 2022 · cited 23× · PMID 36003388 · DOI 10.3389/fimmu.2022.953716
Verify or expand the search:
- PubMed search for NCT03838354
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Chidamide
Trials testing the same drug.
- NCT07493109 — Chidamide for Maintenance Treatment of HBV-infected Diffuse DLBCL in Patients Initially Treated With R-CHOP · Phase 3 · recruiting
- NCT07493148 — Chidamide Combination With R-mini CHOP Followed by Chidamide+CD20 Maintenance in Elderly Newly Diagnosed MYC/BCL2+ DLBCL · Phase 2 · recruiting
- NCT07415980 — Phase Ib/II Study of Polatuzumab Vedotin in Combination With Rituximab and Chidamide in Newly Diagnosed Elderly Patients · Phase 1, PHASE2 · not yet recruiting
- NCT07507318 — Chidamide Maintenance for MRD-Positive Double-Expressor DLBCL in First Complete Remission · Phase 2 · not yet recruiting
- NCT07320963 — Chidamide in Combination With Toripalimab and Anlotinib in Recurrent/Metastatic Nasopharyngeal Carcinoma. · Phase 1, PHASE2 · not yet recruiting
Other recruiting trials for Thrombocytopenia
Currently open trials in the same condition.
- NCT07441720 — Safety and Efficacy of Umbilical Cord Blood Therapy for Cancer Therapy-Induced Thrombocytopenia (CTIT) · Phase 2 · recruiting
- NCT07442513 — Comparison of Etamsylate Versus Placebo to Prevent Bleeding in HSCT · Phase 3 · recruiting
- NCT07257809 — Herombopag Treated T-DM1 Induced Platelet Reduction · Phase 2 · recruiting
- NCT06676904 — Neonatal Platelet Transfusion Threshold Trial · NA · recruiting
- NCT06886516 — Apixaban in Thrombocytopenia · EARLY_PHASE1 · recruiting
Other Shandong University trials
Trials by the same sponsor.
- NCT07288346 — Effect of Predictive Model on Double-Balloon Enteroscopy · NA · recruiting
- NCT07325344 — Active Locomotion of Magnetically Controlled Capsule Endoscopy in the Small Bowel: A Feasibility Study · NA · recruiting
- NCT07319312 — Evaluating the Effect of Nurse-Led Stroke Transitional Care in Tanzania · recruiting
- NCT07391787 — Low-acid Contrast Media for Preventing Post ERCP Pancreatitis · completed
- NCT07066059 — Study on the Efficacy and Safety of Shouhui Tongbian Capsules in Protecting Intestine During the Perioperative Period · EARLY_PHASE1 · not yet 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 NCT03838354 (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 Shandong University
- Last refreshed: 26 August 2025
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/NCT03838354.
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