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 @ 2:43 PM
Ignite Modification Date:
2025-12-24 @ 2:43 PM
NCT ID:
NCT04398459
Eligibility Criteria:
Inclusion Criteria:
* ECOG ≤ 3
* Age from 6 to 70.
* Diagnosed with WAIHA or MAIHA.
* Meets the criteria of relapsed / refractory AIHA.
* Meets the criteria of DAT-negative AIHA without any other inherited or acquired hemolytic diseases, and previously treated effectively with glucocorticoids and rituximab.
* Signed informed consent.
* Organs in good function.
Exclusion Criteria:
* Nursing woman
* Active bacterial, virus, fungal or parasitic infection, including HIV infection, HbsAg and HBV DNA positive, HCV DNA positive, etc.
* Diagnosed with cold agglutinin disease or cold agglutinin syndrome or paroxysmal cold hemoglobinuria.
* Secondary AIHA caused by drugs or infection.
* Received rituximab in 8 weeks before enrollment.
* Previously received treatment with BTK inhibitor.
* Previously received organ or stem cell transplantation.
* Have a history of thrombosis or organ infarction.
* Diagnosed with an active stage of connective tissue disease.
* Have a history of lymphoproliferative tumors or any other malignant tumors.
* Have other inherited or acquired hemolytic diseases.
* Received low-molecular-weight heparin or warfarin within 1 week before enrollment or during the Ibrutinib treatment.
* Received CYP3A4 Enzyme Inhibitors or Inducers within 1 week before enrollment or during the Ibrutinib treatment.
* Have a history of mental illness.
* Inability to understand or to follow study procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
70 Years
Study:
NCT04398459
Study Brief:
Protocol Section:
NCT04398459