Using a CD38 antibody with corticosteroids to treat acquired hemophilia A
A Multicenter, Single-arm Exploratory Study of CD38 (Daratumumab) Monoclonal Antibody (Daratumumab) Combined Corticosteroid in the Treatment of Acquired Hemophilia A (AHA)
This study is testing if a combination of a new antibody treatment and steroids can help people with acquired hemophilia A stop bleeding and stay healthy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Drugs / interventions | Daratumumab |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT05849740 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a combination treatment using the CD38 monoclonal antibody Daratumumab and corticosteroids for patients with acquired hemophilia A (AHA). It is a prospective, single-arm, multi-center pilot trial that aims to assess the time of response, sustained remission rates, and relapse rates associated with this treatment. Additionally, the study will monitor the safety profile of Daratumumab in this patient population. Participants will receive the treatment and be closely monitored throughout the trial.
Who should consider this trial
Good fit: Ideal candidates for this study are postmenopausal women or women of childbearing age with strict contraception who have been diagnosed with acquired hemophilia A.
Not a fit: Patients with congenital hemophilia, those who are pregnant or lactating, or individuals with certain viral infections will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for managing acquired hemophilia A, potentially improving patient outcomes.
How similar studies have performed: While this approach is novel in the context of acquired hemophilia A, similar studies using monoclonal antibodies have shown promise in other hematological conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tianjin
- Chinese Academy of Medical Science and Blood Disease Hospital — Tianjin, China (Recruiting)
Study contacts
- Principal investigator: Lei Zhang — Chinese Academy of Medical Science and Blood Disease Hospital
- Study coordinator: Wei Liu
- Email: liuwei1@ihcams.ac.cn
- Phone: +8613820261971
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.