Phase III Study on HMPL-523 for Treatment of ITP (NCT05029635) | Clinical Trial Compass
CompletedPhase 3
Phase III Study on HMPL-523 for Treatment of ITP
China272 participantsStarted 2021-10-27
Plain-language summary
The purpose of this study is to determine whether HMPL-523 (sovleplenib) is safe and effective in the treatment of chronic Immune Thrombocytopenic Purpura (ITP).
Who can participate
Age range
18 Years – 75 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
. Voluntary signature of written informed consent form;
. Male or female aged 18\~75 years;
. Performance Status score \[Eastern Cooperative Oncology Group (ECOG) score\] 0\~1;
. Having been diagnosed as ITP prior to randomization, and duration of disease is more than 6 months;
. Intolerance or insufficient response, or recurrence after at least one anti-ITP standard drug therapy;
. Patients must have a history of response to previous ITP therapy;
. One combined anti-ITP therapy is allowed in this study, however, the following criteria need to be met:
. The dose of glucocorticoid has been stable for 4 weeks prior to randomization (\<20 mg Prednisone equivalent);
Exclusion criteria
. Evidence on the presence of secondary causes of immune thrombocytopenia;
. Clinically serious hemorrhage requiring immediate adjustment of platelet (e.g., hypermenorrhea with significantly decreased hemoglobin);
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.
. Clinically symptomatic gastrointestinal hemorrhage within 6 months prior to screening visit (e.g., haematemesis, tarry stool, however, the positive occult blood test without any sign or symptom of gastrointestinal hemorrhage will not be considered as "clinically symptomatic", or hemorrhoids hemorrhage is one exception);
. known history of vital organ transplantation or hematopoietic stem cell / bone marrow transplantation;
. Has received live vaccine within 8 weeks prior to Day 1 (baseline visit); or plan for immunization with live vaccine during the study;
. Splenectomy within 12 weeks prior to randomization;
. Major surgery within 4 weeks prior to the randomization, or plan for major elective surgery during the study;
. Previous history of malignant tumors (except for the basal cell carcinoma of skin or cervical carcinoma in situ that have been cured);