Actively Recruiting

Phase 4
Age: 29Days - 14Years
All Genders
NCT05520892

Two Regimens of IVIG in the Treatment of Newly Diagnosed ITP in Children

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

580

Participants Needed

1

Research Sites

203 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

To compare the efficacy of two different dosage regimens of intravenous immune globulin (IVIG) in the treatment of children with newly diagnosed immune thrombocytopenia, and to reduce related adverse reactions and economic burdens on the premise of ensuring the remission rate

CONDITIONS

Official Title

Two Regimens of IVIG in the Treatment of Newly Diagnosed ITP in Children

Who Can Participate

Age: 29Days - 14Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Meet the diagnostic criteria of ITP and be diagnosed for the first time without treatment
  • Age > 28 days and 3 14 years old
  • Platelet count (PLT) < 20�d7109/L
  • Have signed the informed consent
Not Eligible

You will not qualify if you...

  • Intracranial hemorrhage or severe gastrointestinal or urinary tract hemorrhage needing emergency treatment
  • Received glucocorticoid or IVIG treatment within the last 6 months
  • Weight > 40 kg
  • Menstrual female patients
  • Underlying tumor, autoimmune, or genetic diseases
  • Received radiotherapy or chemotherapy
  • Significant other serious diseases or mental illnesses affecting safety, consent, participation, follow-up, or results 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

Fuzhou, Fujian, China, 350001

Actively Recruiting

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Research Team

S

Shaohua Le, Master's degree

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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