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

Fujian Medical University (FJMU)

Status and phase: Enrolling; Phase 4

Conditions: Child, Only; Immune Thrombocytopenia; Glucocorticoids

Treatments: Drug: Dexamethasone; Drug: Prednisone

Study type: Interventional

Funder types: Other

Identifiers

NCT05522465

2022YF025-01

Details and patient eligibility

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)

Enrollment: 608 estimated patients

Sex: All

Ages: 29 days to 14 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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608 participants in 2 patient groups

prednisone group

Experimental group

Description:

prednisone 4mg/kg.d

Treatment:

Drug: Prednisone

Dexamethasone

Active Comparator group

Description:

Dexamethasone 0.6mg/kg.d

Treatment:

Drug: Dexamethasone