An Exploratory Study of Cluster of Differentiation 38 (CD38) Monoclonal Antibody Combined Corticosteroid in Acquired Hemophilia A
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Daratumumab and corticosteroid treatment.
- Who it may be relevant to
- Registry conditions: Acquired Hemophilia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter, Single-arm Exploratory Study of CD38 (Daratumumab) Monoclonal Antibody (Daratumumab) Combined Corticosteroid in the Treatment of Acquired Hemophilia A (AHA)
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.
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.
Interventions
- Drug Daratumumab and corticosteroid treatment
Daratumumab and corticosteroid treatment
Primary outcome measures
- Total response rate to treatment (OR) Total response rate to treatment [Time frame: During 8 weeks]
Secondary outcome measures (6)
- the proportion of patients with complete remission (CR) [Time frame: During 8 weeks]
- the proportion of patients with partial remission rate (PR) [Time frame: During 8 weeks]
- time to CR [Time frame: During 8 weeks]
- The proportion of patients remaining in CR during 24 weeks [Time frame: During 24 weeks]
- The proportion of patients relapse after reaching CR during 24 weeks [Time frame: During 24 weeks]
- Safety outcome [Time frame: From start of the treatment until the end of 24 weeks in the follow-up period]
Eligibility 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%).
Acquired von Willebrand disease
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Chinese Academy of Medical Science and Blood Disease Hospital — Tianjin
Identifiers
NCT: NCT05849740 · IIT2023013