RecruitingPhase 4NCT05520892

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

A Multicenter, Randomized Controlled Study of Two Regimens of Intravenous Immune Globulin in the Treatment of Newly Diagnosed Immune Thrombocytopenia in Children


Sponsor

Fujian Medical University Union Hospital

Enrollment

580 participants

Start Date

Oct 6, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 29 DaysMax Age: 14 Years

Inclusion Criteria4

  • Meet the diagnostic criteria of ITP and be diagnosed for the first time without treatment
  • Age > 28 days and ≤ 14 years old
  • PLT<20×109/L
  • Have signed the informed consent

Exclusion Criteria7

  • Intracranial hemorrhage or severe gastrointestinal or urinary tract hemorrhage requiring emergency treatment, such as simultaneous use of platelet transfusion and glucocorticoid therapy
  • Received glucocorticoid or IVIG therapy within 6 months
  • Weight > 40kg
  • Menstrual female patients
  • Patients with underlying diseases such as tumor diseases, autoimmune diseases or genetic diseases
  • Patients who have received radiotherapy and chemotherapy
  • 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 -

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Interventions

DRUGintravenous immunoglobulin

To compare the efficacy of two different dosage regimens of intravenous immune globulin (IVIG) in the treatment of children with newly diagnosed immune thrombocytopenia


Locations(1)

Children with newly dignosed ITP

Fuzhou, Fujian, China

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NCT05520892