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

February 28, 2023 updated by: Fujian Medical University Union Hospital

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

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

608

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Fujian, Fujian, China
        • Recruiting
        • Children with newly dignosed ITP
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: prednisone group
prednisone 4mg/kg.d
Drug: Prednisone
Prednisone 4mg/kg.d, d1-4
Active Comparator: Dexamethasone
Dexamethasone 0.6mg/kg.d
Drug: Dexamethasone
Dexamethasone 0.6mg/kg.d, d1-4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
initial treatment response
Time Frame: 30 days after treatment
Platelet count after glucocorticoid therapy 1 month
30 days after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Medical University Union Hospital

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2022

Primary Completion (Anticipated)

August 31, 2025

Study Completion (Anticipated)

August 31, 2026

Study Registration Dates

First Submitted

August 29, 2022

First Submitted That Met QC Criteria

August 29, 2022

First Posted (Actual)

August 31, 2022

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022YF025-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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