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

Study acronym: AHA2023
StatusRecruiting
PhasePhase 4
Started2023-05-22
View on ClinicalTrials.gov ↗

Amendment history

2025-07-31
minor
Study Status, Study Design v3
Enrollment target10→25
2025-02-20
minor
Study Identification, Study Status, Sponsor/Collaborators v2
Re-verified, no change to tracked fields
2023-05-22
minor
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v1
Start dateestimated 2023-05-09→confirmed 2023-05-22
Enrollment target20→10
InterventionsDaratumumab (Drug)→Daratumumab and corticosteroid treatment (Drug)
Eligibility criteria+32 characters
[...] progressive decreasing trend (the change was less than 50%). Acquired von Willebrand disease
Secondary endpointsdetails revised at 2 of 6 entries
Study description+43 characters
This is a prospective ,single-arm, multi-center controlled pilot trial of CD38 (Daratumumab) monoclonal antibody combined corticosteroid in the treatment of AHA patients. Patients will receive Daratumumab and corticosteroid treatment in this trial.
Study title+24 characters
An Exploratory Study of Cluster of Differentiation 38 (CD38) Monoclonal Antibody Combined Corticosteroid in Acquired Hemophilia A
2023-05-05
minor
Original filing
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.
Trial Details
NCT Number NCT05849740
Lead Sponsor Institute of Hematology & Blood Diseases Hospital, China
Conditions Acquired Hemophilia
Enrollment 25 participants
Start Date 2023-05-22
Primary Completion 2027-04-30 (estimated)
Study Completion 2027-10-31 (estimated)
Updated on ClinicalTrials.gov 2025-08-05