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

Phase 4

Recruiting

• Conditions: Acquired Hemophilia
• Interventions: Drug: Daratumumab and corticosteroid treatment

• Registration Number: NCT05849740
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-04-18
• Study First Submitted QC: 2023-05-05
• Study First Posted: 2023-05-09
• Study Start: 2023-05-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-21
• Primary Completion: 2027-04-30
• Study Completion: 2027-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment arm	Daratumumab and corticosteroid treatment	Daratumumab and corticosteroid treatment

Primary Outcome Measures

Name	Time	Method
Total response rate to treatment (OR) Total response rate to treatment	During 8 weeks	The proportion of patients achieving OR including CR and PR

Secondary Outcome Measures

Name	Time	Method
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
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%
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%, and no bleedings 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
Safety outcome	From start of the treatment until the end of 24 weeks in the follow-up period	Adverse events will be collected

Trial Locations

Locations (1)

Chinese Academy of Medical Science and Blood Disease Hospital; 🇨🇳 Tianjin, China