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

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT05849740
Phase
PHASE4
Status
Recruiting
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Conditions

  • Acquired Hemophilia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 22, 2023
Status verified
Jan 2025
Primary completion
Apr 30, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment arm
    Daratumumab and corticosteroid treatment

Primary Outcome Measure

Total response rate to treatment (OR) Total response rate to treatment [ Time Frame: During 8 weeks ]

Central Contacts