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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Acquired Hemophilia

Intervention / Treatment
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* Drug: Daratumumab and corticosteroid treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br>Daratumumab and corticosteroid treatment | Drug: Daratumumab and corticosteroid treatment<br>* Daratumumab and corticosteroid treatment<br>* Other names: Intervention arm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total response rate to treatment (OR) Total response rate to treatment | The proportion of patients achieving OR including CR and PR | During 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of patients with complete remission (CR) | The proportion of patients achieving CR , which is defined as titer FVIII inhibitor lower than 0.6 Bethesda unit, factor VIII level≥ 50% | During 8 weeks | 
| the proportion of patients with partial remission rate (PR) | 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. | During 8 weeks | 
| time to CR | The time for patients to reach complete remission | During 8 weeks | 
| The proportion of patients remaining in CR during 24 weeks | The proportion of patients who reached CR and remain in CR during 24 weeks of follow -up time | During 24 weeks | 
| The proportion of patients relapse after reaching CR during 24 weeks | The proportion of patients who reached CR and relapse during 24 weeks of follow -up time | During 24 weeks | 
| Safety outcome | Adverse events will be collected | From start of the treatment until the end of 24 weeks in the follow-up period |