Newly Diagnosed Immune Thrombocytopenia in Children, First Line TreatmentPhase 4NCT05520892
Two Regimens of IVIG in the Treatment of Newly Diagnosed ITP in Children
A Phase 4 study testing intravenous immunoglobulin in people with Newly Diagnosed Immune Thrombocytopenia in Children, First Line Treatment, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 29 days to 14 years
- Conditions the study is for
- Newly Diagnosed Immune Thrombocytopenia in Children, First Line Treatment
- What is being tested?
- intravenous immunoglobulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 580 participants
- Where
- 1 siteChina
- Study dates
- 6 Oct 2022to 31 Aug 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 days to 14 years
- All sexes
- No healthy volunteers
- Child
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 -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Children with newly dignosed ITP
Fuzhou, Fujian, 350001
Shaohua Le, Master, 8613365917129, lele883@sina.com
About this study
Official title: A Multicenter, Randomized Controlled Study of Two Regimens of Intravenous Immune Globulin in the Treatment of Newly Diagnosed Immune Thrombocytopenia 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
- Being tested
- intravenous immunoglobulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous immunoglobulinDrug
To compare the efficacy of two different dosage regimens of intravenous immune globulin (IVIG) in the treatment of children with newly diagnosed immune thrombocytopenia
| Study group | Role | What they receive |
|---|---|---|
| low-dose intravenous immunoglobulin | Experimental | 0.4g/kg.d, d1-5 Receives: Drug: intravenous immunoglobulin |
| high-dose intravenous immunoglobulin | Active comparator | 1.0g/kg.d, d1-2 Receives: Drug: intravenous immunoglobulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
early response to treatment
Platelet counts after 7 days of IVIG treatment
Measured: 7 days after treatment
Secondary outcomes (2)
Economic Indicators
Calculate the total amount of IVIG used in 1 week (weight normalized)
Measured: 1 week
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of Treatment-Emergent Adverse Events in 1 week
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start6 Oct 2022
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed Immune Thrombocytopenia in Children, First Line TreatmentStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 580 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Xiamen University, Zhangzhou Affiliated Hospital of Fujian Medical University, Quanzhou First Hospital, Nanping First Hospital Affiliated to Fujian Medical University, The Second Hospital of Anhui Medical University, The Affiliated Hospital Of Guizhou Medical University, Longyan City First Hospital, The Affiliated Hospital of Putian University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520892
- Sponsor's protocol ID
- 2022YF024-01
- Status last verified
- Feb 2024
- First submitted
- 28 Aug 2022
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Controlled Study of Two Regimens of Intravenous Immune Globulin in the Treatment of Newly Diagnosed Immune Thrombocytopenia in Children
- ClinicalTrials.gov ID
- NCT05520892
- Acronym / sponsor ID
- 2022YF024-01
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Xiamen University, Zhangzhou Affiliated Hospital of Fujian Medical University, Quanzhou First Hospital, Nanping First Hospital Affiliated to Fujian Medical University, The Second Hospital of Anhui Medical University, The Affiliated Hospital Of Guizhou Medical University, Longyan City First Hospital, The Affiliated Hospital of Putian University
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low-dose intravenous immunoglobulin | Experimental | Drug: intravenous immunoglobulin0.4g/kg.d, d1-5 |
| high-dose intravenous immunoglobulin | Active comparator | Drug: intravenous immunoglobulin1.0g/kg.d, d1-2 |
Who may qualify
- Ages
- 29 days to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravenous immunoglobulinTo compare the efficacy of two different dosage regimens of intravenous immune globulin (IVIG) in the treatment of children with newly diagnosed immune thrombocytopenia | Drug | high-dose intravenous immunoglobulin, low-dose intravenous immunoglobulin |
Primary outcome
early response to treatment
Time frame: 7 days after treatment
Platelet counts after 7 days of IVIG treatment
2 secondary outcomes
Economic Indicators
Time frame: 1 week
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing intravenous immunoglobulin in people with Newly Diagnosed Immune Thrombocytopenia in Children, First Line Treatment, run by Fujian Medical University Union Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaohua Le, Master's degree (8613365917129, lele883@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early response to treatment (time frame: 7 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.