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NCT05411874
A Multicenter Randomized Open-label Study of Chidamide Plus HD-DEX Versus HD-DEX in ITP
Phase 2 trial testing Chidamide in Thrombocytopenia in 100 participants. Status unknown.
30 October 2023
Quick facts
| Lead sponsor | Shandong University |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 October 2022 |
| Primary completion | 30 October 2023 |
| Estimated completion | 30 October 2024 |
Drugs / interventions tested
Conditions studied
- Thrombocytopenia — all drugs for Thrombocytopenia →
Sponsor
Shandong University
Who can join
Adults 18 to 70, any sex, with Thrombocytopenia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Recently, histone deacetylase inhibitors (HDACi) has been used for their anti-inflammatory and immunomodulatory activities. It has been shown that HDACi can alleviate graft-versus-host disease by enhancing the number and function of Foxp3+ Tregs. Our group found that low-dose HDACi alleviated thrombocytopenia in both passive and active murine models of ITP. Furthermore, low-dose HDACi attenuated macrophage phagocytosis of antibody-coated platelets, stimulated production of natural Foxp3+ Tregs, promoted peripheral conversion of T cells into Tregs, and restored Treg suppressive function in vivo and in vitro. The project was undertaking by Qilu Hospital of Shandong University and other 10 well-known hospitals in China. In order to report the efficacy and safety of the low dose chidamide combined with high-dose dexamethasone versus high-dose dexamethasone in the management of ITP.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05411874
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other trials of Chidamide
Trials testing the same drug.
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- 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.
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Other Shandong University trials
Trials by the same sponsor.
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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 NCT05411874 (US National Library of Medicine, public domain)
- 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: 9 June 2022
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