Autoimmune Hemolytic AnemiaNCT07149818
A Single-arm Phase 2 Prospective Clinical Study of Linprixel in the Treatment of Relapsed/Refractory Autoimmune Hemolytic Anemia
An observational study of Autoimmune Hemolytic Anemia, run by Peking Union Medical College Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Autoimmune Hemolytic Anemia
- What is being tested?
- Parsaclisib
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Record complete demographic data, improve the patient's medical history and physical examination. 2. Routine examinations include blood routine (including reticulocytes), biochemistry (liver and kidney function, lactate dehydrogenase, ferritin, folic acid, vitamin B12), coagulation function, direct anti-human globulin test (DAT) and typing, colagglutinin test, autoantibody, antiphospholipid antibody, immunoglobulin, serum protein electrophoresis, and TB cell subset analysis. Cytokines (flow cytometry), chest and abdominal CT or abdominal ultrasound. 3. Bone Marrow smear, biopsy, flow immunotyping, chromosome (optional)
Who may be able to join
- （1）Age ≥18 years old (2) Clearly diagnosed wAIHA or EVANS syndrome, cAIHA, primary or secondary connective tissue diseases. If it is secondary, there are no indications for the treatment of connective tissue diseases involving other systems.
- Patients who relapse or are refractory after at least two lines of treatment (previous treatments include glucocorticoids, CD20 monoclonal antibodies or at least two other immunosuppressants). Refractory is defined as the failure to achieve partial remission after 3 months of stable dose treatment with immunosuppressants.
- hb≤100 g / L (5) Those with complete clinical data, high treatment compliance, and those who have signed the informed consent form; (6) If glucocorticoids are being taken, they should be discontinued or the minimum maintenance dose has been taken for at least two weeks, and the minimum maintenance dose (≤15mg/day) should be continued subsequently (7) The infusion of CD20 monoclonal antibody should be at least 3 months or more. If the stable dose of immunosuppressants such as cyclosporine and sirolimus has been taken for at least 3 months, they should be discontinued upon enrollment.
Who cannot join
- 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;
- Those who have participated in other clinical trials within three months.
About this study
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.
- Conditions
- Autoimmune Hemolytic Anemia
- Being tested
- Parsaclisib
- Keywords
- Autoimmune Hemolytic Anemia
- Medical subject headings
- Anemia, Hemolytic, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParsaclisibDrug
parsaclisib 40mg qd
| Study group | Role | What they receive |
|---|---|---|
| parsaclisib 40mg qd | Not described Receives: Drug: Parsaclisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall response rate (ORR) at 12 weeks
The overall response rate (ORR)
Measured: 12 weeks
The complete response rate (CRR) at 12 weeks
The complete response rate (CRR) at 12 weeks
Measured: 12 weeks
Secondary outcomes (1)
The incidence of adverse events
The incidence of adverse events
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune Hemolytic AnemiaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Miao, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149818
- Sponsor's protocol ID
- Linperlisib-AIHA
- Status last verified
- Aug 2025
- First submitted
- 11 Jun 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Phase 2 Prospective Clinical Study of Linprixel in the Treatment of Relapsed/Refractory Autoimmune Hemolytic Anemia
- ClinicalTrials.gov ID
- NCT07149818
- Acronym / sponsor ID
- Linperlisib-AIHA
- Conditions
- Autoimmune Hemolytic Anemia
- Keywords
- Autoimmune Hemolytic Anemia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 2 Sep 2025 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| parsaclisib 40mg qd | – | Drug: Parsaclisib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Record complete demographic data, improve the patient's medical history and physical examination. 2. Routine examinations include blood routine (including reticulocytes), biochemistry (liver and kidney function, lactate dehydrogenase, ferritin, folic acid, vitamin B12), coagulation function, direct anti-human globulin test (DAT) and typing, colagglutinin test, autoantibody, antiphospholipid antibody, immunoglobulin, serum protein electrophoresis, and TB cell subset analysis. Cytokines (flow cytometry), chest and abdominal CT or abdominal ultrasound. 3. Bone Marrow smear, biopsy, flow immunotyping, chromosome (optional)
Key inclusion criteria (3 listed)
- （1）Age ≥18 years old (2) Clearly diagnosed wAIHA or EVANS syndrome, cAIHA, primary or secondary connective tissue diseases. If it is secondary, there are no indications for the treatment of connective tissue diseases involving other systems.
- Patients who relapse or are refractory after at least two lines of treatment (previous treatments include glucocorticoids, CD20 monoclonal antibodies or at least two other immunosuppressants). Refractory is defined as the failure to achieve partial remission after 3 months of stable dose treatment with immunosuppressants.
- hb≤100 g / L (5) Those with complete clinical data, high treatment compliance, and those who have signed the informed consent form; (6) If glucocorticoids are being taken, they should be discontinued or the minimum maintenance dose has been taken for at least two weeks, and the minimum maintenance dose (≤15mg/day) should be continued subsequently (7) The infusion of CD20 monoclonal antibody should be at least 3 months or more. If the stable dose of immunosuppressants such as cyclosporine and sirolimus has been taken for at least 3 months, they should be discontinued upon enrollment.
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Parsaclisibparsaclisib 40mg qd | Drug | parsaclisib 40mg qd |
Primary outcome
The overall response rate (ORR) at 12 weeks
Time frame: 12 weeks
The overall response rate (ORR)
The complete response rate (CRR) at 12 weeks
Time frame: 12 weeks
The complete response rate (CRR) at 12 weeks
1 secondary outcome
The incidence of adverse events
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Hemolytic Anemia, run by Peking Union Medical College Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. 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: opening soon, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The overall response rate (ORR) at 12 weeks (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 2 Sep 2025.