The Safety of Repurposing Daratumumab for Relapsed or Refractory Autoimmune Antibody Mediated Hemolytic Anemia
Part of paid clinical trials in Lebanon, New Hampshire.
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Study ID
- NCT05004259
- Phase
- PHASE1
- Status
- Completed
Conditions
- Hemolytic Anemia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Daratumumab / Hyaluronidase Injection — DRUGSubcutaneous injection of daratumumab and hyaluronidase
Study Details
A single-arm study utilizing a 6 x 4 expansion design using daratumumab SC treatment for patients with refractory Autoimmune Hemolytic Anemia.
Key Dates
- Start date
- Mar 21, 2022
- Status verified
- Jan 2024
- Primary completion
- Sep 21, 2024
- Completion
- Sep 21, 2024
Study Design
- Enrollment
- 2 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm 1Six weekly doses of subcutaneous daratumumab 1,800mg and hyaluronidase 30,000U.
Primary Outcome Measure
Determine safety of treatment [ Time Frame: Up to 10 weeks ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | - |
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