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A prospective, multicenter, randomized controlled study of different doses of prednisone in the treatment of children with primary immune thrombocytopenia

A prospective, multicenter, randomized controlled study of different doses of prednisone in the treatment of children with primary immune thrombocytopenia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053452
Enrollment
Unknown
Registered
2021-11-21
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children Primary immune thrombocytopenia

Interventions

experimental group:Prednisone 1.5-2.0mg/kg/d, divided into 2-3 times, the platelet count is stable for 1-2 weeks, and the dose is gradually reduced to withdrawal, and the course of treatment is 4-6 we
control group:Prednisone 3-4.0mg/kg/d for 4-7 days

Sponsors

Huizhou Municipal Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. According to the diagnostic criteria in the Diagnosis and Treatment Guidelines for Primary Immune Thrombocytopenia in Children (2019 edition), the diagnosis of primary ITP is definite, excluding secondary ITP and other congenital and tumor thrombocytopenia. Bone marrow examination; 2. Aged 1 month to 18 years; 3. Newly diagnosed ITP, that is, the duration of the disease is less than 3 months; 4. Have not received platelet-enhancing therapy before diagnosis; 5. Obtain consent from the patient and/or guardian.

Exclusion criteria

Exclusion criteria: 1. Concurrent use of other drugs for the treatment of ITP; 2. Have any significant abnormal coexisting disease or mental illness, which affects the life safety and compliance of the child; 3. Cardiopulmonary failure; 4. Those who have a history of allergy to adrenocortical hormones; 5. Patients with diabetes, hypertension, glaucoma, peptic ulcer.

Design outcomes

Primary

MeasureTime frame
primary response rate;sustained response rate;

Secondary

MeasureTime frame
bleeding score;response time;Reaction duration;

Countries

China

Contacts

Public ContactLiao Liuhua

Huizhou Municipal Central Hospital

liaoliuhua@163.com+86 13542762470

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026