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

Phase 4RecruitingNCT05849740

Institute of Hematology & Blood Diseases Hospital, China25 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acquired Hemophilia

Interventions

Daratumumab and corticosteroid treatmentDRUG

Daratumumab and corticosteroid treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Chinese Academy of Medical Science and Blood Disease Hospital

Tianjin, China

RECRUITING

Outcomes

Primary Outcomes

Total response rate to treatment (OR) Total response rate to treatment

The proportion of patients achieving OR including CR and PR

Time frame: During 8 weeks

Secondary Outcomes

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%

Time frame: 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.

Time frame: During 8 weeks

time to CR

The time for patients to reach complete remission

Time frame: 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

Time frame: 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

Time frame: During 24 weeks

Safety outcome

Adverse events will be collected

Time frame: From start of the treatment until the end of 24 weeks in the follow-up period

Central Contacts

Wei Liu

CONTACT

+8613820261971 liuwei1@ihcams.ac.cn

Lei Zhang

CONTACT

zhanglei1@ihcams.ac.cn

Data from ClinicalTrials.gov

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