Acquired Hemophilia
Conditions
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.
Interventions
DRUGDaratumumab and corticosteroid treatment
Daratumumab and corticosteroid treatment
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
| Safety outcome | From start of the treatment until the end of 24 weeks in the follow-up period | Adverse events will be collected |
| 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 |
Countries
China
Contacts
Primary ContactWei Liu
Backup ContactLei Zhang
Outcome results
None listed