NCT06913374

The Study of Different Cycles of High-dose Dexamethasone in the Treatment of ITP

Dicycle Versus Tri-cycle High-dose Dexamethasone in Adult ITP: a Multicenter Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 118 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In this multicentre, open-label, randomized controlled trial, about 118 new-diagnosed ITP patients will be enrolled from five tertiary medical centres in China. Eligible participants are randomly assigned (1:1) to 2 groups: group DEX2 and group DEX3. In group DEX2, dexamethasone was administered orally at 40 mg per day for two cycles (days1-4, and days 11-14). In group DEX3, dexamethasone was administered orally at 40 mg per day for three cycles (days1-4, days 11-14, and days 21-24). The clinical effect, onset time, duration of efficacy and adverse reactions were observed to compare the efficacy and safety of two different plans.

Conditions

• Thrombocytopenia

Interventions

Type	Name	Description
DRUG	Dexamethasone	given orally at 40 mg per day for two cycles (days1-4, and days 11-14).
DRUG	Dexamethasone	given orally at 40 mg per day for three cycles (days1-4, days 11-14, and days 21-24).

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-05-30
• Completion: 2027-05-30
• First posted: 2025-04-06
• Last updated: 2025-04-08

Locations

1 site across 1 country: China