Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin, China
Location status: Recruiting
Recruiting
NCT Number: NCT05849740
An Exploratory Study of Cluster of Differentiation 38 (CD38) Monoclonal Antibody Combined Corticosteroid in Acquired Hemophilia A
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Daratumumab and corticosteroid treatment
DrugDaratumumab and corticosteroid treatment
Other names: Intervention arm
Primary outcomes
-
Total response rate to treatment (OR) Total response rate to treatment
Time frame: During 8 weeks
The proportion of patients achieving OR including CR and PR
Secondary outcomes
-
the proportion of patients with complete remission (CR)
Time frame: During 8 weeks
The proportion of patients achieving CR , which is defined as titer FVIII inhibitor lower than 0.6 Bethesda unit, factor VIII level≥ 50%
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the proportion of patients with partial remission rate (PR)
Time frame: During 8 weeks
The proportion of patients achieving PR, which is defined as titer FVIII inhibitor higher than 0.6 Bethesda unit and factor VIII level≥ 50%, and no bleedings will be evaluated.
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time to CR
Time frame: During 8 weeks
The time for patients to reach complete remission
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The proportion of patients remaining in CR during 24 weeks
Time frame: During 24 weeks
The proportion of patients who reached CR and remain in CR during 24 weeks of follow -up time
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The proportion of patients relapse after reaching CR during 24 weeks
Time frame: During 24 weeks
The proportion of patients who reached CR and relapse during 24 weeks of follow -up time
-
Safety outcome
Time frame: From start of the treatment until the end of 24 weeks in the follow-up period
Adverse events will be collected
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
Other
Registry information
Official study title
A Multicenter, Single-arm Exploratory Study of CD38 (Daratumumab) Monoclonal Antibody (Daratumumab) Combined Corticosteroid in the Treatment of Acquired Hemophilia A (AHA)
Acronym: AHA2023
Important dates
- Study start
- 2023
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- May 9, 2023
- Registry last updated
- Aug 5, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.