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Clinical Trials in China / NCT04398459
Active, not recruiting Phase 2

The Safety and Efficacy of Ibrutinib in Refractory/Relapsed Autoimmune Hemolytic Anemia

NCT04398459 · tracked via the Priya Life Science China tracker
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Phase
Phase 2
Started
2020-05-01
Last updated
2024-09-25

Condition(s) studied

Refractory/Relapsed Autoimmune Hemolytic Anemia

Investigational drug(s) / intervention(s)

Ibrutinib

Ibrutinib: Each recruited subject will accept Ibrutinib treatment.

Study summary

This is an open-label, single-arm study to evaluate the safety and efficacy of Ibrutinib in subjects with refractory/relapsed autoimmune hemolytic anemia.

Eligibility

Sex
ALL
Min age
6 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Zhoukou Central Hospital Zhoukou Henan
The Second Affilated Hospital of Shandong First Medical University Tai’an Shandong
Regenerative Medicine Center Tianjin Tianjin Municipality

On this site

📄 Imbruvica (ibrutinib) drug profile →

More Institute of Hematology & Blood Diseases Hospital, China trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04398459 on ClinicalTrials.gov ↗ ← All trials in China