The Study of Different Cycles of High-dose Dexamethasone in the Treatment of ITP
Condition(s) studied
Investigational drug(s) / intervention(s)
Dexamethasone: given orally at 40 mg per day for two cycles (days1-4, and days 11-14).
Dexamethasone: given orally at 40 mg per day for three cycles (days1-4, days 11-14, and days 21-24).
Study summary
Primary immune thrombocytopenia is an autoimmune disorder characterised by decreased platelet counts and increased bleeding risk. Corticosteroids have been the standard initial treatment of primary immune thrombocytopenia for more than 30 years. The aim of this randomized controlled trial is to compare the efficacy and safety of high-dose dexamethasone in treating new-diagnosed primary immune thrombocytopenia (ITP) in di-cycle and tri-cycle.
Eligibility
Primary outcome measure(s)
- Sustained response — Month 6
Sustained response was defined as platelet count maintained above 30 × 10\^9/L with an absence of bleeding symptoms or no requirement for additional ITP treatment for six consecutive months following achievement of initial response. Complete response was defined as a platelet count of 100 × 10\^9 cells per L or higher and an absence of bleeding. Partial response was defined as a platelet count of 30×10\^9 cells per L or higher, but less than 100×10\^9 cells per L, and at least a doubling of the baseline platelet count and an absence of bleeding.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Qilu hospital of Shandong university | Jinan | Shandong |
More Shandong University trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06913374 on ClinicalTrials.gov ↗ ← All trials in China