TPO-RAs Combining Anti-CD 20 Monoclonal Antibody Versus TPO-RAs in the Management of Pediatric Pr… (NCT05718856) | Clinical Trial Compass
UnknownPhase 4
TPO-RAs Combining Anti-CD 20 Monoclonal Antibody Versus TPO-RAs in the Management of Pediatric Primary Immune Thrombocytopenia (ITP)
China166 participantsStarted 2023-02-23
Plain-language summary
This multicenter randomized, open-label study aim to compare the efficacy and safety of TPO-RAs combining anti-CD 20 monoclonal antibody with TPO-RAs in China pediatric ITP patients .This study will be conducted in persistent or chronic pediatric ITP patients who had not responded to or had relapsed after previous glucocorticoid treatment.
Who can participate
Age range
6 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 6-17 years old (including both ends), male and female;
. Patients aged 6-11 years (including values at both ends) were diagnosed with chronic ITP, and patients aged 12-17 years (including values at both ends) were diagnosed with persistent or chronic ITP, with platelet counts less than 20×109/L;
. Patients did not respond to glucocorticoid therapy or relapsed. Previous ITP treatment may include, but is not limited to, glucocorticoids, immunomodulators (IVIG), azathioprine, danazole, cyclophosphamide and immunomodulators.
. Treatment for ITP (including but not limited to glucocorticoids, recombinant human thrombopoietin, TPO agonist (TPO-RA), azathioprine, danazole, cyclosporin A, mycophenate) must be completed or dose stabilized before enrollment, and therapeutic dose should not be increased after enrollment (e.g. The glucocorticoid dose should be stable for ≥14 days and the immunosuppressant dose should be stable for \> 3 months before the first administration of the study drug. TPO drugs should be stopped \> 1 month, TPO-RA drugs should be stopped \> 1 month).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Treatment response
Timeframe: From the start of study treatment (Day 1) up to the end of week 4, week 8 and week 12.
Trial details
NCT IDNCT05718856
SponsorInstitute of Hematology & Blood Diseases Hospital, China
. No infectious fever (including but not limited to lung infection) in the past 1 month.
. Laboratory examination of coagulation function should show that the prothrombin time (PT) and activated partial thrombin time (aPTT) values did not exceed 20% of the normal laboratory value range; No history of abnormal coagulation except for ITP.
. WBC count, neutrophil absolute value and hemoglobin should be within the normal range of laboratory values. No other abnormality except for ITP. Other exceptions except the following:
. Understand the study procedure and voluntarily sign the informed consent.
Exclusion criteria
. Subjects who has any history of arterial/venous thrombosis and the following risk factors including clotting factor V Leiden disease, ATIII deficiency, antiphospholipid syndrome, etc..
. Subjects known to have failed all standard TPO-RAs treatments.
. Subjects known to have taken anti-CD20 antibodytreatment within 3 months prior to initial use of the study drug.
. Within 2 weeks prior to the initial use of the study drug, subjects were treated with medications (including but not limited to aspirin, aspirin containing compounds, clopidogrel, salicylate, and/or NSAIDs) or anticoagulants that had an impact on platelet function for \> 3 consecutive days.
. Subjects known to have participated in other investigational clinical trials within 3 months prior to first use of investigational drug.
. Suffering from severe, progressive, uncontrolled kidney, liver, gastrointestinal, endocrine, lung, heart, nervous system, brain or psychiatric disorders.
. HIV infection with laboratory or clinical diagnosis.
. Previous history of hepatitis C, chronic hepatitis B infection, or evidence of active hepatitis. Laboratory tests at the screening stage indicate seropositivity for hepatitis C or hepatitis B seropositivity (HBsAg positive). In addition, if HBsAg is negative but HBcAb is positive (regardless of HBsAb status), HBV DNA testing is required, and if positive, the subject should be excluded.