Not Yet RecruitingNot Applicable

A Multicenter Prospective Study of Iptacopan in the Treatment of Refractory/Relapsed Autoimmune Hemolytic Anemia (AIHA)

China20 participantsStarted 2025-03-01

Plain-language summary

To evaluate the efficacy and safety of ipecopam in the treatment of refractory/relapsed AIHA.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Voluntarily signed an informed consent form (ICF);
✓. Males or females aged 18 or older;
✓. Physical status score \[Eastern Cooperative Oncology Group (ECOG) score\] ≤2;
✓. Confirmed diagnosis of primary AIHA or secondary autoimmune disease (except rheumatoid arthritis and systemic lupus erythematosus) with underlying disease in a stable state;
✓. Poor response to at least previous glucocorticoid therapy, including ineffective (defined as failure to achieve stabilization of Hb levels at 100 g/L or erythrocyte hematocrit \<30% despite at least 4 weeks of treatment with previously recommended doses), or glucocorticoid-dependent (defined as maintenance of equal doses of prednisone exceeding 15 mg/d), or relapsed (defined as treatment that is effective and then again has an Hb of \<100 g/L or an erythrocyte hematocrit of \<30%), or otherwise contraindicated. 30%), or otherwise contraindicated or intolerant to glucocorticoid therapy;
✓. Hemoglobin (Hb) \<100 g/L before drug administration;
✓. Positive direct anti-human globulin test (DAT) (IgA, IgM or IgG+, with or without C3+).
✓. Combination of one anti-AIHA therapy \[glucocorticoids only (≤15 mg prednisone equivalent), immunosuppressants (azathioprine, cyclosporine, and merti-macrolide only)\] is permitted in this study, provided that the dose has been stable for at least 28 days prior to enrollment;

✕. Presence of secondary AIHA outside the inclusion criteria;
✕. Hb \<100 g/L due to non-AIHA factors; and
✕. Infections requiring systemic therapy;
✕. Those with a past history of malignancy (except cured basal cell carcinoma of the skin or cervical carcinoma in situ);
✕. With history of vital organ transplantation or hematopoietic stem cell/bone marrow transplantation;
✕. Those who have undergone splenectomy within 24 weeks prior to enrollment;
✕. Those who have had major surgery within four weeks prior to enrollment or who require major elective surgery during the study period;
✕. History of severe cardiovascular disease \[e.g., class III/IV congestive heart failure, arrhythmia or angina requiring medication, unstable angina, coronary stenting, angioplasty or coronary artery bypass grafting, or corrected Q-T interval (QTcF) ≥ 90 mmHg\]

Timeframe: 3 months

Timeframe: 6 months

NCT IDNCT06847607

SponsorBing Han

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-30

Bing Han Han

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Voluntarily signed an informed consent form (ICF);
✓. Males or females aged 18 or older;
✓. Physical status score \[Eastern Cooperative Oncology Group (ECOG) score\] ≤2;
✓. Confirmed diagnosis of primary AIHA or secondary autoimmune disease (except rheumatoid arthritis and systemic lupus erythematosus) with underlying disease in a stable state;
✓. Poor response to at least previous glucocorticoid therapy, including ineffective (defined as failure to achieve stabilization of Hb levels at 100 g/L or erythrocyte hematocrit \<30% despite at least 4 weeks of treatment with previously recommended doses), or glucocorticoid-dependent (defined as maintenance of equal doses of prednisone exceeding 15 mg/d), or relapsed (defined as treatment that is effective and then again has an Hb of \<100 g/L or an erythrocyte hematocrit of \<30%), or otherwise contraindicated. 30%), or otherwise contraindicated or intolerant to glucocorticoid therapy;
✓. Hemoglobin (Hb) \<100 g/L before drug administration;
✓. Positive direct anti-human globulin test (DAT) (IgA, IgM or IgG+, with or without C3+).
✓. Combination of one anti-AIHA therapy \[glucocorticoids only (≤15 mg prednisone equivalent), immunosuppressants (azathioprine, cyclosporine, and merti-macrolide only)\] is permitted in this study, provided that the dose has been stable for at least 28 days prior to enrollment;

✕. Presence of secondary AIHA outside the inclusion criteria;
✕. Hb \<100 g/L due to non-AIHA factors; and
✕. Infections requiring systemic therapy;
✕. Those with a past history of malignancy (except cured basal cell carcinoma of the skin or cervical carcinoma in situ);
✕. With history of vital organ transplantation or hematopoietic stem cell/bone marrow transplantation;
✕. Those who have undergone splenectomy within 24 weeks prior to enrollment;
✕. Those who have had major surgery within four weeks prior to enrollment or who require major elective surgery during the study period;
✕. History of severe cardiovascular disease \[e.g., class III/IV congestive heart failure, arrhythmia or angina requiring medication, unstable angina, coronary stenting, angioplasty or coronary artery bypass grafting, or corrected Q-T interval (QTcF) ≥ 90 mmHg\]