Using a CD38 antibody with corticosteroids to treat acquired hemophilia A
Official title: A Multicenter, Single-arm Exploratory Study of CD38 (Daratumumab) Monoclonal Antibody (Daratumumab) Combined Corticosteroid in the Treatment of Acquired Hemophilia A (AHA)
Run by Institute of Hematology & Blood Diseases Hospital, China · NCT05849740 · Data updated 2026-11-12
This study is testing if a combination of a new antibody treatment and steroids can help people with acquired hemophilia A stop bleeding and stay healthy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Drugs / interventions | Daratumumab |
| Locations | 1 site (Tianjin) |
| Status | Recruiting |
| Started | May 22, 2023 |
| Main results expected | April 30, 2027 |
| Study ends | October 31, 2027 |
| Registry record updated | August 5, 2025 |
| Trial ID | NCT05849740 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are postmenopausal women or women of childbearing age with strict contraception who have been diagnosed with acquired hemophilia A.
✕Probably not a fit
Patients with congenital hemophilia, those who are pregnant or lactating, or individuals with certain viral infections will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of a combination treatment using the CD38 monoclonal antibody Daratumumab and corticosteroids for patients with acquired hemophilia A (AHA). It is a prospective, single-arm, multi-center pilot trial that aims to assess the time of response, sustained remission rates, and relapse rates associated with this treatment. Additionally, the study will monitor the safety profile of Daratumumab in this patient population. Participants will receive the treatment and be closely monitored throughout the trial.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for managing acquired hemophilia A, potentially improving patient outcomes.
How similar studies have gone: While this approach is novel in the context of acquired hemophilia A, similar studies using monoclonal antibodies have shown promise in other hematological conditions.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients must meet all enrollment criteria before they can be enrolled: Diagnosed as AHA; Women are postmenopausal women or women of childbearing age with strict contraception; Patients with good compliance Exclusion Criteria: * Patients with any of the following items cannot be enrolled in this study: Congenital hemophilia with inhibitor; Pregnant and lactating women; Who are positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody (Ⅰ + Ⅱ) and syphilis antibody; Patients with poor compliance; Who cannot use contraception during the trial; Researchers believe that it is not appropriate for patients to participate in any other condition of this trial; Four weeks before entering the group, the patients received immunosuppressive therapy and the inhibitor showed a progressive decreasing trend (the change was less than 50%). Acquired von Willebrand disease
Where it's running
-
Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin, China Recruiting
Study contacts
- Principal investigator: Lei Zhang — Chinese Academy of Medical Science and Blood Disease Hospital
- Study coordinator: Wei Liu
- Email: liuwei1@ihcams.ac.cn
- Phone: +8613820261971
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Fewer-doses daratumumab added to VRd for newly diagnosed multiple myeloma
This study tests whether a less-frequent daratumumab dosing plan added to VRd can help patients with newly diagnosed multiple myeloma achieve more MRD negativity.
-
BCD-248 plus daratumumab in relapsed or refractory multiple myeloma
This study tests whether adding BCD-248 to daratumumab helps people with relapsed or refractory multiple myeloma who have had prior lines of therapy.
-
Tec Dara for newly diagnosed multiple myeloma with light chain amyloidosis
This study tests whether tec listamab plus daratumumab can help newly diagnosed multiple myeloma with AL amyloidosis and whether the combination is safe.
-
Daratumumab for acquired immune thrombotic thrombocytopenic purpura
This project tests whether daratumumab can raise ADAMTS13 activity in adults with acquired (immune) TTP who did not respond to or could not tolerate standard immunosuppressive treatments.
-
A combination therapy for teens and young adults with relapsed or refractory T-ALL/T-LBL
This phase 1 study tests a four-drug regimen (venetoclax, dexamethasone, bortezomib, and daratumumab) in adolescents and young adults whose T-cell ALL or T-cell lymphoblastic lymphoma has come back or not responded.
-
Maintaining myeloma with less frequent daratumumab plus lenalidomide
This phase 2 study tests a reduced-dosing schedule of daratumumab with lenalidomide to maintain remission in adults with multiple myeloma after stem cell transplant.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.