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

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · May 5, 2023

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ClinConnect Summary

**Clinical Trial Summary: CD38 Monoclonal Antibody for Acquired Hemophilia A**

This clinical trial is studying a new treatment approach for patients with Acquired Hemophilia A (AHA), a rare blood disorder that can cause excessive bleeding. The researchers are looking at how effective a medication called Daratumumab, a type of antibody, combined with corticosteroids (a type of anti-inflammatory medicine) is in helping patients respond to treatment, stay in remission, and avoid relapses. They also want to ensure that this treatment is safe for patients.

To participate in this study, you need to be diagnosed with AHA and be a woman who is either postmenopausal or of childbearing age using strict contraception. Unfortunately, if you have other types of hemophilia, are pregnant or breastfeeding, or have certain infections like hepatitis or HIV, you won’t be able to join. If you decide to participate, you’ll be monitored closely to see how well the treatment works and if there are any side effects. The trial is currently recruiting participants aged 65 to 74, and both men and women are welcome to apply.

Gender

ALL

Eligibility 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