AHA2023: An Exploratory Study of Cluster of Differentiation 38 (CD38) Monoclonal Antibody in Acquired Hemophilia A
Study Details
Study Description
Brief Summary
To evaluate the time of response, sustained remission rate and relapse rate of CD38 monoclonal antibody (Daratumumab) in the treatment of AHA. To evaluate the safety of CD38 monoclonal antibody in the treatment of AHA.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
This is a prospective ,single-arm, multi-center controlled pilot trial of CD38 (Daratumumab) monoclonal antibody in the treatment of AHA patients.
Patients will receive Daratumumab treatment in this trial.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment arm Daratumumab treatment |
Drug: Daratumumab
Daratumumab treatment
Other Names:
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Outcome Measures
Primary Outcome Measures
- Total response rate to treatment (OR) Total response rate to treatment [During 8 weeks]
The proportion of patients achieving OR defined as factor VIII level> 50% and no bleeding events without bypass treatments for 24 hours will be evaluated.
Secondary Outcome Measures
- the proportion of patients with complete remission (CR) [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% and no bleeding events without bypass treatments for 24 hours , will be evaluated
- the proportion of patients with partial remission rate (PR) [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%, will be evaluated.
- time to CR [During 8 weeks]
The time for patients to reach complete remission
- The proportion of patients remaining in CR during 24 weeks [During 24 weeks]
The proportion of patients who reached CR and remain in CR during 24 weeks of follow -up time
- The proportion of patients relapse after reaching CR during 24 weeks [During 24 weeks]
The proportion of patients who reached CR and relapse during 24 weeks of follow -up time
- Safety outcome [From start of the treatment until the end of 24 weeks in the follow-up period]
Adverse events will be collected
Eligibility Criteria
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%).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chinese Academy of Medical Science and Blood Disease Hospital | Tianjin | China |
Sponsors and Collaborators
- Institute of Hematology & Blood Diseases Hospital
Investigators
- Principal Investigator: Lei Zhang, Chinese Academy of Medical Science and Blood Disease Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AHA2023