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NCT05849740RecruitingPhase 4

An Exploratory Study of Cluster of Differentiation 38 (CD38) Monoclonal Antibody Combined Corticosteroid in Acquired Hemophilia A

A Multicenter, Single-arm Exploratory Study of CD38 (Daratumumab) Monoclonal Antibody (Daratumumab) Combined Corticosteroid in the Treatment of Acquired Hemophilia A (AHA)

Source: ClinicalTrials.gov · Last updated 5 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

To evaluate the time of response, sustained remission rate and relapse rate of CD38 monoclonal antibody (Daratumumab) combined corticosteroid in the treatment of AHA. To evaluate the safety of CD38 monoclonal antibody in the treatment of AHA.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
25 (estimated)
First submitted
18 Apr 2023
Start date
22 May 2023
Primary completion date
30 Apr 2027
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
Diseases
Haemophilia
NCT number
NCT05849740

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 25
  • From 22 May 2023 to the primary completion date, 30 Apr 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Chinese Academy of Medical Science and Blood Disease Hospital
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TianjinChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.