Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 and up

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

PhasePhase 4
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment25 (estimated)
SponsorInstitute of Hematology & Blood Diseases Hospital, China
Academic / other
Drugs / interventionsDaratumumab
Locations1 site (Tianjin)
StatusRecruiting
StartedMay 22, 2023
Main results expectedApril 30, 2027
Study endsOctober 31, 2027
Registry record updatedAugust 5, 2025
Trial IDNCT05849740 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.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.