A Single-arm Phase 2 Prospective Clinical Study of Linprixel in the Treatment of Relapsed/Refract… (NCT07149818) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Single-arm Phase 2 Prospective Clinical Study of Linprixel in the Treatment of Relapsed/Refractory Autoimmune Hemolytic Anemia
22 participantsStarted 2025-09-01
Plain-language summary
wAIHA or EVANS syndrome: Linpriril 40mg, oral, once daily. The therapeutic effect will be evaluated after 4 weeks. If the therapeutic effect does not reach the PR, the dose will be increased to 60mg once a day. After continuing to take it for 4 weeks, the therapeutic effect will be evaluated again. If the PR is not reached, it can be increased to 80mg. If the PR is still not reached after continuing to take it for 4 weeks, it will be discontinued (for a total of 12 weeks). The initial dose is 40mg, taken orally once a day. If the therapeutic effect reaches PR or above after 4 weeks, continue taking this dose. The evaluation is the same as before every 4 weeks. The research period was 12 weeks. The duration of continuous treatment for effective patients is determined by the researchers, and the dosage of the drug can be reduced or increased.
cAIHA: Linpriril 80mg, oral administration, once daily. The therapeutic effect was evaluated every 4 weeks. The research period was 12 weeks. The treatment was discontinued if the therapeutic effect did not reach the PR within 12 weeks. The duration of continuous treatment for effective patients is determined by the researchers, and the dosage of the drug can be reduced or increased.
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.
Exclusion criteria
. Those with incomplete functions of organs such as the heart, liver and lungs; Patients with acute renal insufficiency
. Combined with connective tissue diseases, other vital organs are involved.
. Uncontrolled infection or bleeding after standard treatment. Standard treatment for uncontrolled active infections of HIV, HCV or HBV.
. Combined with advanced uncontrolled malignant tumors and lymphomas.
. At the time of screening, the subjects had other types of uncorrected anemia, such as nutritional anemia, etc
. Pregnant or lactating women.
. Those who have used PI3Kδ inhibitors within the past 6 months;
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.