AIHA - Warm Autoimmune Hemolytic AnemiaNICHE-AIHANCT07019038
National Longitudinal Cohort of Hematological Diseases- Autoimmune Hemolytic Anemia
An observational study of AIHA - Warm Autoimmune Hemolytic Anemia and AIHA - Cold Autoimmune Hemolytic Anemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- AIHA - Warm Autoimmune Hemolytic Anemia, AIHA - Cold Autoimmune Hemolytic Anemia, Autoimmune Hemolytic Anemia Mixed Type
- What is being tested?
- A combined retrospective and prospective observational follow-up
- How many people
- 9,999 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2001to 31 Dec 2070
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Subjects diagnosed with AIHA.
- Hemoglobin<100g/L
- Subjects treated at the Institute of Hematology and Blood Diseases Hospital from Jan 1, 2001.
Who cannot join
- Subject unlikely to be available for long-term follow-up for any reason (e.g., inability to obtain follow-up data or presence of severe comorbidities).
- Subject with alcohol or drug dependence may reduce their compliance with the study.
- Subjects that the investigator believes have other reasons that make them unsuitable for inclusion in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Red Blood Cell Diseases Center and Regenerative Medicine Center
Tianjin, Tianjin Municipality
Lele Zhang, PhD, 15811139278, zhanglele@ihcams.ac.cn
About this study
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.
- Analyze the demographic and clinical characteristics of patients with AIHA, including sex, age, disease severity, and other relevant factors.
- Examine disease features of AIHA patients, such as biochemical and hematological indicators
- Assess treatment patterns and real-world effectiveness in AIHA patients.
- Evaluate clinical outcomes, including hematologic response, relapse, and mortality
- Investigate long-term prognosis, including post-discontinuation outcomes and health-related quality of life.
- Conditions
- AIHA - Warm Autoimmune Hemolytic Anemia, AIHA - Cold Autoimmune Hemolytic Anemia, Autoimmune Hemolytic Anemia Mixed Type
- Being tested
- A combined retrospective and prospective observational follow-up
- Keywords
- Autoimmune Hemolytic Anemia, Treatment patterns, Hematologic response
- Medical subject headings
- Anemia, Hemolytic, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A combined retrospective and prospective observational follow-upOther
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.
| Study group | Role | What they receive |
|---|---|---|
| NICHE-AIHA | Patients who were diagnosed with AIHA in the investigating hospitals from Jan 1, 2001. Receives: Other: A combined retrospective and prospective observational follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematologic response
Hematologic response contains improvements in hemoglobin.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 Jan 2001
- Primary completion31 Dec 2070 (estimated)
- Study completion31 Dec 2070 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AIHA - Warm Autoimmune Hemolytic AnemiaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 9,999 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019038
- Sponsor's protocol ID
- IIT2025042
- Acronym
- NICHE-AIHA
- Status last verified
- May 2025
- First submitted
- 28 May 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Longitudinal Cohort of Hematological Diseases- Autoimmune Hemolytic Anemia
- ClinicalTrials.gov ID
- NCT07019038
- Acronym / sponsor ID
- NICHE-AIHA / IIT2025042
- Conditions
- AIHA - Warm Autoimmune Hemolytic Anemia, AIHA - Cold Autoimmune Hemolytic Anemia, Autoimmune Hemolytic Anemia Mixed Type
- Keywords
- Autoimmune Hemolytic Anemia, Treatment patterns, Hematologic response
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 9,999 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Jan 2001 (actual)
- Primary completion
- 31 Dec 2070 (estimated)
- Study completion
- 31 Dec 2070 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Analyze the demographic and clinical characteristics of patients with AIHA, including sex, age, disease severity, and other relevant factors.
- Examine disease features of AIHA patients, such as biochemical and hematological indicators
- Assess treatment patterns and real-world effectiveness in AIHA patients.
- Evaluate clinical outcomes, including hematologic response, relapse, and mortality
- Investigate long-term prognosis, including post-discontinuation outcomes and health-related quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NICHE-AIHA | – | Other: A combined retrospective and prospective observational follow-upPatients who were diagnosed with AIHA in the investigating hospitals from Jan 1, 2001. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Subjects diagnosed with AIHA.
- Hemoglobin<100g/L
- Subjects treated at the Institute of Hematology and Blood Diseases Hospital from Jan 1, 2001.
Key exclusion criteria (3 listed)
- Subject unlikely to be available for long-term follow-up for any reason (e.g., inability to obtain follow-up data or presence of severe comorbidities).
- Subject with alcohol or drug dependence may reduce their compliance with the study.
- Subjects that the investigator believes have other reasons that make them unsuitable for inclusion in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A combined retrospective and prospective observational follow-upThe 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. | Other | NICHE-AIHA |
Primary outcome
Hematologic response
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.
Hematologic response contains improvements in hemoglobin.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AIHA - Warm Autoimmune Hemolytic Anemia and AIHA - Cold Autoimmune Hemolytic Anemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lele Zhang, PhD (15811139278, zhanglele@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematologic response (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.