Short-course High-dose Prednisone and Dexamethasone in Children With ITP
NCT ID: NCT05522465
Last Updated: 2024-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
608 participants
INTERVENTIONAL
2022-10-11
2026-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
High-dose Dexamethasone Versus Conventional Dose Prednisone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)
NCT01356511
rhTPO Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of ITP
NCT01734044
Different Cycles of High-dose Dexamethasone for Initial Management of Primary Immune Thrombocytopenia (ITP)
NCT02642380
High-dose Dexamethasone Combining Thalidomide Versus Dexamethasone Mono-therapy for Management of Newly-diagnosed ITP
NCT01976195
An Investigation of Dexamethasone With Different Doses in the Management of Immune Thrombocytopenia (ITP)
NCT02153060
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
prednisone group
prednisone 4mg/kg.d
Prednisone
Prednisone 4mg/kg.d, d1-4
Dexamethasone
Dexamethasone 0.6mg/kg.d
Dexamethasone
Dexamethasone 0.6mg/kg.d, d1-4
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Prednisone
Prednisone 4mg/kg.d, d1-4
Dexamethasone
Dexamethasone 0.6mg/kg.d, d1-4
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
29 Days
14 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The First Affiliated Hospital of Xiamen University
OTHER
Zhangzhou Affiliated Hospital of Fujian Medical University
OTHER
Quanzhou First Hospital
OTHER
Nanping First Hospital Affiliated to Fujian Medical University
UNKNOWN
The Second Hospital of Anhui Medical University
OTHER
The Affiliated Hospital Of Guizhou Medical University
OTHER
Longyan City First Hospital
OTHER
The Affiliated Hospital of Putian University
OTHER
Fujian Medical University Union Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Children with newly dignosed ITP
Fujian, Fujian, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022YF025-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.