A Phase 2 interventional study of Zanubrutinib in Refractory/Relapsed Autoimmune Hemolytic Anemia, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Recruiting at 1 site in China. Open to participants aged 6 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-11-29.
Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Phase 2, Interventional, and Treatment
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 2nd largest by planned enrollment of the 11 interventional ones that give a count, is one of 2 that started in 2023, is one of 3 in phase 2, reaches primary completion later than 2 of the 11 other live ones, and was the 5th 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
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: 6 Years to 70 Years · 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. 2 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 33 is above the median of 23 across 78 interventional 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 |
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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.
The sample size of this study is calculated based on Simon's two-stage design. The first stage of the study enrolled a cohort of 12 patients. If after 12 weeks at least 6 patients achieved a response, then enrollment was expanded to a total of 26 patients. The null hypothesis was unaccepted if more than 14 of 26 patients achieved the response. Accounting for a 20% dropout rate, the estimated final sample size was 33 patients.
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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Each recruited subject will accept Zanubrutinib treatment.
Drug: Zanubrutinib
Zanubrutinib was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity.
Overall response rate
The percentage of patients achieved complete response, complete response with incomplete hemolysis recovery, and partial response.
Time frame: within 12 weeks
Incidence of adverse events and severe adverse events
Time frame: within 24 weeks
Relapse free survival rate
Time frame: within 48 weeks
Started Sep 2023 (actual). Primary completion is estimated for Sep 2025, 24 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Zanubrutinib
Anemia, Hemolytic, Autoimmune →
Institute of Hematology & Blood Diseases Hospital, China →