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

Sponsor
Shandong University
Study ID
NCT06913374
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 1, 2025
Status verified
Apr 2025
Primary completion
May 30, 2026
Completion
May 30, 2027

Study Design

Enrollment
118 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: group DEX2
    In group DEX2, dexamethasone was administered orally at 40 mg per day for two cycles (days1-4, and days 11-14).
  • Experimental: group DEX3
    In group DEX3, dexamethasone was administered orally at 40 mg per day for three cycles (days1-4, days 11-14, and days 21-24).

Primary Outcome Measure

Sustained response [ Time Frame: Month 6 ]

Central Contacts

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