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NCT Number: NCT05522465

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

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)

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Key information

Conditions

Immune Thrombocytopenia Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Child, Only Cytopenia Glucocorticoids Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

29 day–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Exclusion criteria

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

  • 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.)
  • Received glucocorticoid therapy within 6 months
  • Menstrual female children
  • Patients with underlying diseases such as tumor diseases, autoimmune diseases or genetic diseases
  • Patients who have received radiotherapy and chemotherapy
  • There are contraindications to the use of glucocorticoids (hypertension, glaucoma, peptic ulcer, etc.)
  • 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

Treatment and study plan

Prednisone

Drug

Prednisone 4mg/kg.d, d1-4

Dexamethasone

Drug

Dexamethasone 0.6mg/kg.d, d1-4

Primary outcomes

  1. initial treatment response

    Time frame: 30 days after treatment

    Platelet count after glucocorticoid therapy 1 month

Secondary outcomes

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

    Time frame: 1 month

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

Study contacts

Contact information is provided by the study sponsor or research team.

Yongzhi Zheng, PhD

CONTACT

[email protected]

8613459414385

Sponsors and collaborators

Lead sponsor

Fujian Medical University Union Hospital

Other

Collaborators

  • Longyan City First Hospital
  • Nanping First Hospital Affiliated to Fujian Medical University
  • Quanzhou First Hospital
  • The Affiliated Hospital Of Guizhou Medical University
  • The Affiliated Hospital of Putian University
  • The First Affiliated Hospital of Xiamen University
  • The Second Hospital of Anhui Medical University
  • Zhangzhou Affiliated Hospital of Fujian Medical University

Registry information

Official study title

Short-course High-dose Prednisone and Dexamethasone in Children With Immune A Multicenter, Randomized Controlled Study of Thrombocytopenia

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Aug 31, 2022
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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