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

NCT ID: NCT05849740

Last Updated: 2025-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-22

Study Completion Date

2027-10-31

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.

Conditions

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Acquired Hemophilia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment arm

Daratumumab and corticosteroid treatment

Group Type EXPERIMENTAL

Daratumumab and corticosteroid treatment

Intervention Type DRUG

Daratumumab and corticosteroid treatment

Interventions

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Daratumumab and corticosteroid treatment

Daratumumab and corticosteroid treatment

Intervention Type DRUG

Other Intervention Names

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Intervention arm

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lei Zhang

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Science and Blood Disease Hospital

Locations

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Chinese Academy of Medical Science and Blood Disease Hospital

Tianjin, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei Liu

Role: CONTACT

+8613820261971

Lei Zhang

Role: CONTACT

Facility Contacts

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Shuo Chen

Role: primary

Lijun Liu

Role: backup

Other Identifiers

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IIT2023013

Identifier Type: -

Identifier Source: org_study_id

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