A Clinical Trial to Assess Safety and Efficacy of Daratumumab in the Treatment of Primary Immune Thrombocytopenia
NCT05562882 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2025-05-28
Summary
A single-center, open-label, off-label use investigator-initiated clinical study to explore the clinical activity and safety of daratumumab in adult ITP patients who have not responded adequately or relapsed after first-line treatment and at least one second-line therapy including rituximab and/or TPO-RA.
Conditions
Interventions
- DRUG
-
Daratumumab Injection
intravenous daratumumab administration
Sponsors & Collaborators
-
Institute of Hematology & Blood Diseases Hospital, China
lead OTHER
Principal Investigators
-
Lei Zhang, M.D. · Institute of Hematology & Blood Diseases Hospital, China
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-10
- Primary Completion
- 2025-01-31
- Completion
- 2025-12-31
Countries
- China
Study Locations
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