Immune Thrombocytopenia Clinical Trial
Official title:
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)
Status | Recruiting |
Enrollment | 608 |
Est. completion date | August 31, 2026 |
Est. primary completion date | August 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 29 Days to 14 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Children with newly dignosed ITP | Fujian | Fujian |
Lead Sponsor | Collaborator |
---|---|
Fujian Medical University Union Hospital | Longyan City First Hospital, Nanping First Hospital Affiliated to Fujian Medical University, Quanzhou First Hospital Affiliated to Fujian Medical University, 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 |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | initial treatment response | Platelet count after glucocorticoid therapy 1 month | 30 days after treatment | |
Secondary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Incidence of Treatment-Emergent Adverse Events occurring within 1 month of glucocorticoid therapy | 1 month |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02287649 -
Polymorphism and Auto-reactive B and T Cells Subsets in Adult's Immune Thrombocytopenia (ITP)
|
N/A | |
Completed |
NCT02556814 -
Caffeic Acid Combining High-dose Dexamethasone in Management of ITP
|
Phase 4 | |
Terminated |
NCT02401061 -
PRTX-100-202 Open-Label, Dose Escalation Study in Adult Patients With ITP
|
Phase 1/Phase 2 | |
Completed |
NCT02868099 -
Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Immune Thrombocytopenia (ITP)
|
Phase 3 | |
Completed |
NCT02351622 -
Caffeic Acid Tablets as a Second-line Therapy for ITP
|
Phase 3 | |
Active, not recruiting |
NCT04741139 -
Post IVIG Medication in Children With Immune Thrombocytopenia
|
Phase 1 | |
Not yet recruiting |
NCT05494307 -
The Combination of Terbutaline and Danazol as the Treatment of Corticosteroid-resistant/Relapse Immune Thrombocytopenia
|
Phase 2 | |
Not yet recruiting |
NCT05468866 -
The Expression of Immune Checkpoint CD28 rs1980422-related Single-nucleotide Polymorphisms in the Primary Immune Thrombocytopenia
|
N/A | |
Recruiting |
NCT05281068 -
The Combination of Iguratimod and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia
|
Phase 2 | |
Recruiting |
NCT04993885 -
Avatrombopag in the Treatment of Adult Immune Thrombocytopenia With Autoantibodies
|
Phase 2 | |
Not yet recruiting |
NCT05020288 -
A Clinical Trial of the Orelabrutinib in the Management of Refractory ITP
|
Phase 2 | |
Withdrawn |
NCT03965624 -
Efficacy and Safety of Ixazomib and Dexamethasone Refractory Autoimmune Cytopenia
|
Phase 2 | |
Not yet recruiting |
NCT03252457 -
Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITP
|
Phase 3 | |
Recruiting |
NCT05937828 -
OBS'CEREVANCE: French Cohort of Pediatric Autoimmune Cytopenia
|
||
Completed |
NCT03156452 -
Newly Diagnosed Immune Thrombocytopenia Testing the Standard Steroid Treatment Against Combined Steroid & Mycophenolate
|
Phase 3 | |
Completed |
NCT03164915 -
A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP)
|
Phase 3 | |
Recruiting |
NCT02270801 -
Recombinant Human Thrombopoietin (rhTPO) in Management of Immune Thrombocytopenia (ITP) in Pregnancy
|
Phase 3 | |
Withdrawn |
NCT01976195 -
High-dose Dexamethasone Combining Thalidomide Versus Dexamethasone Mono-therapy for Management of Newly-diagnosed ITP
|
Phase 2 | |
Completed |
NCT01933035 -
Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias.
|
N/A | |
Recruiting |
NCT02821572 -
Role of Fcgamma Receptors in Immune Thrombocytopenia (ITP)
|