Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2025-12-24 @ 12:43 PM
NCT ID:
NCT06177561
Eligibility Criteria:
Inclusion Criteria:
1. Serum DSA positive: MFI ≥ 2000；Between the ages of 18 and 65, male and female are not limited；Planned to undergo allo-HSCT , with an estimated survival time of\>3 months and an ECOG physical fitness score of 0-2；Normal renal function (BUN, Cr ≤ 1.5 times the upper limit of normal value, Ccr\>80ml/min)
2. Normal liver function (defined as ALT and AST ≤ 1.5 times the upper limit of normal
3. TBiL ≤ 1.5 times the upper limit of normal)
4. ECG did not indicate any AMI, arrhythmia, or IAVB
5. No CI (defined as LVEF ≥ 50%, normal MYO and BNP)
6. Non active RHD
7. Chest X-ray or physical examination did not indicate cardiac dilatation
8. Normal lung function (defined as FEV1, FVC, DLCO ≥ 60% predicted value)
Exclusion criteria：
1. Patients with severe allergies to blood products
2. The following comorbidities exist: active infection patients, active rheumatism patients
3. Patients with secondary immunoglobulin deficiency
4. Serious damage to important organ functions, such as respiratory failure, heart failure, decompensated liver dysfunction, renal dysfunction, etc
5. Unable to obtain informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06177561
Study Brief:
Protocol Section:
NCT06177561