Children with newly dignosed ITP
Fuzhou, Fujian, 350001, China
Location status: Recruiting
Recruiting
NCT Number: NCT05520892
Two Regimens of IVIG in the Treatment of Newly Diagnosed ITP in Children
To compare the efficacy of two different dosage regimens of intravenous immune globulin (IVIG) in the treatment of children with newly diagnosed immune thrombocytopenia, and to reduce related adverse reactions and economic burdens on the premise of ensuring the remission rate
Recruiting
Interested in participating?
Request InfoKey information
Age range
29 day–14 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Subjects enrolled in this study must meet all of the following criteria:
- Meet the diagnostic criteria of ITP and be diagnosed for the first time without treatment
- Age > 28 days and ≤ 14 years old
- PLT<20×109/L
- Have signed the informed consent
Exclusion criteria
Anyone who has any of the following conditions will not enter the clinical study:
- Intracranial hemorrhage or severe gastrointestinal or urinary tract hemorrhage requiring emergency treatment, such as simultaneous use of platelet transfusion and glucocorticoid therapy
- Received glucocorticoid or IVIG therapy within 6 months
- Weight > 40kg
- Menstrual female patients
- Patients with underlying diseases such as tumor diseases, autoimmune diseases or genetic diseases
- Patients who have received radiotherapy and chemotherapy
- 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 -
Treatment and study plan
intravenous immunoglobulin
DrugTo compare the efficacy of two different dosage regimens of intravenous immune globulin (IVIG) in the treatment of children with newly diagnosed immune thrombocytopenia
Primary outcomes
-
early response to treatment
Time frame: 7 days after treatment
Platelet counts after 7 days of IVIG treatment
Secondary outcomes
-
Economic Indicators
Time frame: 1 week
Calculate the total amount of IVIG used in 1 week (weight normalized)
-
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 1 week
Incidence of Treatment-Emergent Adverse Events in 1 week
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Fujian Medical University Union Hospital
Other
Collaborators
- Longyan City First Hospital
- Nanping First Hospital Affiliated to Fujian Medical University
- Quanzhou First Hospital
- 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
Registry information
Official study title
A Multicenter, Randomized Controlled Study of Two Regimens of Intravenous Immune Globulin in the Treatment of Newly Diagnosed Immune Thrombocytopenia in Children
Important dates
- Study start
- 2022
- Primary completion
- 2025
- Study completion
- 2026
- First posted
- Aug 30, 2022
- Registry last updated
- May 16, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.