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NCT02556814
A Prospective, Multicenter, Placebo Controlled Study on Caffeic Acid Tablet Combining High-dose Dexamethasone in Management of Adult Primary Immune Thrombocytopenia (ITP)
Phase 4 trial testing Caffeic acid tablets in Immune Thrombocytopenia in 214 participants. Completed in 1 October 2018.
1 March 2018
Quick facts
| Lead sponsor | Shandong University |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 214 |
| Start date | 1 September 2015 |
| Primary completion | 1 March 2018 |
| Estimated completion | 1 October 2018 |
| Sites | 1 location across China |
Drugs / interventions tested
- Caffeic acid tablets — full drug profile →
- Dexamethasone (dexamethasone) — full drug profile →
- placebo
Conditions studied
- Immune Thrombocytopenia — all drugs for Immune Thrombocytopenia →
Sponsor
Shandong University
Who can join
Adults 18 to 75, any sex, with Immune Thrombocytopenia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
sustained response to ITP treatments
Time frame: 6 months after treatment started
percentage of patients maintaining PLT count over 30\*10\^9 without bleeding
Sponsor's own description
The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of caffeic acid tablets combining with high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting epigenetic regulators to overcome drug resistance in cancers.
Wang N, Ma T, Yu B, Yu B. · · 2023 · cited 213× · PMID 36797239 · DOI 10.1038/s41392-023-01341-7 -
Novel Biomarkers for Diagnosis and Monitoring of Immune Thrombocytopenia.
Allegra A, Cicero N, Mirabile G, Giorgianni CM, et al · · 2023 · cited 17× · PMID 36901864 · DOI 10.3390/ijms24054438 -
Caffeic acid tablets plus high-dose dexamethasone versus placebo plus high-dose dexamethasone in patients with newly diagnosed immune thrombocytopenia: A multicenter, double-blind, randomized, controlled, phase 2 trial.
Wang R, Liu Y, Wang R, Cao J, et al · · 2025 · cited 1× · PMID 40846660 · DOI 10.1097/cm9.0000000000003783
Verify or expand the search:
- PubMed search for NCT02556814
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Immune Thrombocytopenia
Currently open trials in the same condition.
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- 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
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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 NCT02556814 (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: 19 March 2020
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/NCT02556814.
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