High-dose prednisone and dexamethasone treatment for children with ITP
Short-course High-dose Prednisone and Dexamethasone in Children With Immune A Multicenter, Randomized Controlled Study of Thrombocytopenia
This study is testing whether high doses of prednisone or dexamethasone can help increase platelet counts in children with immune thrombocytopenia who have just been diagnosed.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 608 (estimated) |
| Ages | 29 Days to 14 Years |
| Sex | All |
| Sponsor | Fujian Medical University Union Hospital Academic / other |
| Drugs / interventions | chemotherapy, prednisone |
| Locations | 1 site (Fujian, Fujian) |
| Trial ID | NCT05522465 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the efficacy and safety of short-course high-dose prednisone and dexamethasone in treating children diagnosed with immune thrombocytopenia (ITP) within the last three months. The study aims to determine which of the two glucocorticoids is more effective in increasing platelet counts in this patient population. Eligible participants include children aged between 28 days and 14 years who have not received prior treatment for ITP. The trial will assess outcomes related to platelet levels and any adverse effects associated with the treatments.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 28 days to 14 years who have been newly diagnosed with immune thrombocytopenia and have not received prior glucocorticoid therapy.
Not a fit: Patients with severe bleeding complications, underlying diseases, or those who have recently received glucocorticoid therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for children with ITP, potentially improving their platelet counts and overall health.
How similar studies have performed: While there have been studies on glucocorticoids for ITP, this specific comparison of high-dose short-course treatments is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Fujian, Fujian
- Children with newly dignosed ITP — Fujian, Fujian, China (Recruiting)
Study contacts
- Study coordinator: Yongzhi Zheng, PhD
- Email: brandy850728@163.com
- Phone: 8613459414385
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.