An observational study in AIHA - Warm Autoimmune Hemolytic Anemia, AIHA - Cold Autoimmune Hemolytic Anemia and Autoimmune Hemolytic Anemia Mixed Type, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Observational
Among 15 studies in Anemia, Hemolytic, Autoimmune by Institute of Hematology & Blood Diseases Hospital, China — 8 open to participants now, 12 under way, none of them phase 3. Anemia, Hemolytic, Autoimmune · Institute of Hematology & Blood Diseases Hospital, China.
Among the 15 studies in Anemia, Hemolytic, Autoimmune by Institute of Hematology & Blood Diseases Hospital, China, this one is the only one that started in 2001, is one of 4 observational ones, reaches primary completion later than 11 of the 11 other live ones, and was the 11th registered.
103 studies on the registry are indexed under Anemia, Hemolytic, Autoimmune; 39 are open to participants now.
Browse Anemia, Hemolytic, Autoimmune studies →8 of the 15 studies in Anemia, Hemolytic, Autoimmune by Institute of Hematology & Blood Diseases Hospital, China are open now, in 1 country. Recruiting first, the newest first:
Institute of Hematology & Blood Diseases Hospital, China · Sites in China
Ages 18–75
Institute of Hematology & Blood Diseases Hospital, China · Sites in China
Ages 18–65
Institute of Hematology & Blood Diseases Hospital, China · Sites in China
Ages 18–65
Institute of Hematology & Blood Diseases Hospital, China · Sites in China
Ages 6–70
Institute of Hematology & Blood Diseases Hospital, China · Sites in China
By country, each count listing its studies:
Of the 24 Anemia, Hemolytic, Autoimmune studies recruiting now, 12 (50%) set no upper age limit and 10 (42%) stop at 75 or younger; 5 take children under 18; none take healthy volunteers.
This study: all sexes · no healthy volunteers.
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15 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 1 started in 2001.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 9,999 is above the median of 175 across 20 observational studies indexed under Anemia, Hemolytic, Autoimmune.
Median enrollment 12 across the 11 interventional studies, 1,312 across the 4 observational. Of the 2 that completed or were terminated, 0 (0%) have results posted.
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Institute of Hematology & Blood Diseases Hospital, China is the lead sponsor of 412 studies on the registry; 291 are open to participants now.
3 of the studies in Anemia, Hemolytic, Autoimmune by Institute of Hematology & Blood Diseases Hospital, China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06733610Institute of Hematology & Blood Diseases Hospital, ChinaCAR T-cell Therapy Targeting CD19 and BCMA in Patients With AIHA Who Have Failed ≥3 Lines of Therapy. | 2027-01-12 |
| NCT07689604Institute of Hematology & Blood Diseases Hospital, ChinaMETA 10-19 in Patients With Relapsed/Refractory Autoimmune Hemolytic Anemia | 2027-05-01 |
| NCT06770504Institute of Hematology & Blood Diseases Hospital, ChinaA Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia | 2027-06-30 |
Add all 3 to your calendar (.ics) → With an account.
Among the 15 studies in Anemia, Hemolytic, Autoimmune by Institute of Hematology & Blood Diseases Hospital, China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Hematological diseases are disorders of the blood and hematopoietic organs. The current hematological cohorts are mostly based on single-center or multi-center cases, or cohorts with limited sample size in China. There is a lack of comprehensive and large-scale prospective cohort studies in hematology.
The objectives of this study are to investigate the incidence and risk factors of autoimmune hemolytic anemia (AIHA) and to analyze the treatment effectiveness, patient prognosis and healthcare costs in China.
Patients diagnosed as AIHA.
Diagnostic criteria for AIHA (Autoimmune Hemolytic Anemia):
Hemoglobin level meets the diagnostic threshold for anemia; Decreased serum haptoglobin (\<250 mg/L), elevated total bilirubin (≥17.1 μmol/L, mainly indirect bilirubin), elevated lactate dehydrogenase (LDH), and reticulocyte percentage >4% or absolute reticulocyte count >120×10\^9/L; Presence of autoantibodies against red blood cells.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who were diagnosed with AIHA in the investigating hospitals from Jan 1, 2001.
Other: A combined retrospective and prospective observational follow-up
The NICHE-AIHA will collect basic information, diagnostic and treatment information, as well as health costs information of patients from medical records. The study will use questionnaire to measure the exposure of patients, and prospectively follow-up to collect the prognosis information.
Hematologic response
Hematologic response contains improvements in hemoglobin.
Time frame: Assessments will be conducted at baseline, 6 months, 12 months, and 24 months after treatment, as well as at study completion, with an average interval of approximately 1 year.
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2001 (actual). Primary completion is estimated for Dec 2070, 839 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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