Actively Recruiting

Phase 4
Age: 29Days - 14Years
All Genders
NCT05522465

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

Led by Fujian Medical University Union Hospital · Updated on 2024-05-16

608

Participants Needed

1

Research Sites

202 weeks

Total Duration

On this page

Sponsors

F

Fujian Medical University Union Hospital

Lead Sponsor

T

The First Affiliated Hospital of Xiamen University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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)

CONDITIONS

Official Title

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

Who Can Participate

Age: 29Days - 14Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Meet the immune thrombocytopenia (ITP) diagnostic criteria within 3 months of first diagnosis
  • Age greater than 28 days and up to 14 years old
  • Untreated platelet count less than 20 x 10^9/L, or platelet count less than 30 x 10^9/L after 1 week of intravenous gamma globulin treatment
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Intracranial hemorrhage or severe gastrointestinal or urinary tract bleeding requiring emergency treatment, including use of platelet transfusion and thrombopoietic drugs
  • Received glucocorticoid therapy within the past 6 months
  • Female children who are menstruating
  • Patients with tumor diseases, autoimmune diseases, or genetic diseases
  • Patients who have received radiotherapy or chemotherapy
  • Contraindications to glucocorticoids such as hypertension, glaucoma, or peptic ulcer
  • Significant coexisting diseases or mental illnesses affecting safety, consent, participation, follow-up, or result interpretation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Children with newly dignosed ITP

Fujian, Fujian, China

Actively Recruiting

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Research Team

Y

Yongzhi Zheng, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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