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RecruitingNCT05522465Updated May 16, 2024

Short-course High-dose Prednisone and Dexamethasone in Children With ITP

A Phase 4 interventional study of Prednisone and Dexamethasone in Immune Thrombocytopenia, Glucocorticoids and Child, Only, sponsored by Fujian Medical University Union Hospital. Recruiting at 1 site in China. Open to participants aged 29 Days to 14 Years. Per ClinicalTrials.gov, last updated 2024-05-16.

Sponsored by Fujian Medical University Union Hospital · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Oct 2022; still recruiting 3 years 11 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
608
Allocation
Randomized
Ages
29 Days to 14 Years
Sex
All
01

Study summary

Comparison of the efficacy and safety of short-course high-dose prednisone and dexamethasone in the treatment of children with newly diagnosed immune thrombocytopenia (ITP)

02

Conditions studied

  • Immune Thrombocytopenia
  • Glucocorticoids
  • Child, Only
03

In context

Thrombocytopenia

697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.

This study's planned enrollment of 608 is above the median of 55 across 472 interventional studies indexed under Thrombocytopenia.

Browse Thrombocytopenia studies →

Lead sponsor

Fujian Medical University Union Hospital is the lead sponsor of 100 studies on the registry; 72 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
29 Days to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:Subjects enrolled in this study must meet all of the following criteria:

  1. Meet the ITP diagnostic criteria, within 3 months of the first diagnosis
  2. Age > 28 days and ≤ 14 years old
  3. Untreated PLT\<20×109/L, or PLT\<30×109/L after 1 week of intravenous gamma globulin (IVIG) treatment
  4. Have signed the informed consent

Exclusion Criteria:Anyone who has any of the following conditions will not enter the clinical study:

  1. Intracranial hemorrhage or severe gastrointestinal or urinary tract hemorrhage requiring emergency treatment, such as simultaneous use of platelet transfusion and thrombopoietic drugs (recombinant human thrombopoietin, eltrombopag, etc.)
  2. Received glucocorticoid therapy within 6 months
  3. Menstrual female children
  4. Patients with underlying diseases such as tumor diseases, autoimmune diseases or genetic diseases
  5. Patients who have received radiotherapy and chemotherapy
  6. There are contraindications to the use of glucocorticoids (hypertension, glaucoma, peptic ulcer, etc.)
  7. There are any significant abnormal coexisting diseases or mental illnesses that affect the patient's life safety and compliance, and affect informed consent, research participation, follow-up or interpretation of results
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
608 participants (estimated)

Study arms

  • Experimental
    prednisone group

    prednisone 4mg/kg.d

    Drug: Prednisone

  • Active comparator
    Dexamethasone

    Dexamethasone 0.6mg/kg.d

    Drug: Dexamethasone

Interventions

  • DrugPrednisone

    Prednisone 4mg/kg.d, d1-4

  • DrugDexamethasone

    Dexamethasone 0.6mg/kg.d, d1-4

06

What researchers measure

Primary outcomes

  1. initial treatment response

    Platelet count after glucocorticoid therapy 1 month

    Time frame: 30 days after treatment

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Incidence of Treatment-Emergent Adverse Events occurring within 1 month of glucocorticoid therapy

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
  • Children with newly dignosed ITP
    Fujian, Fujian, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05522465
Lead sponsor
Fujian Medical University Union Hospital
Collaborators
The First Affiliated Hospital of Xiamen University, Zhangzhou Affiliated Hospital of Fujian Medical University, Quanzhou First Hospital, Nanping First Hospital Affiliated to Fujian Medical University, The Second Hospital of Anhui Medical University, The Affiliated Hospital Of Guizhou Medical University, Longyan City First Hospital, The Affiliated Hospital of Putian University
Responsible party
Sponsor
First posted
Aug 31, 2022
Start date
Oct 11, 2022
Primary completion
Aug 31, 2025 (estimated)
Completion
Aug 31, 2026 (estimated)
Last update
May 16, 2024

Study contacts

Yongzhi Zheng, PhD
Contact
brandy850728@163.com
8613459414385

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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