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NCT05004259 · ClinicalTrials.gov registry record · Phase 1
The Safety of Repurposing Daratumumab for Relapsed or Refractory Autoimmune Antibody Mediated Hemolytic Anemia
A Phase 1 study, sponsored by Dartmouth-Hitchcock Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT05004259: Completed Phase 1 study, sponsored by Dartmouth-Hitchcock Medical Center.
NCT05004259 is a Phase 1 study that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05004259, a Phase 1 study, has completed, sponsored by Dartmouth-Hitchcock Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
A single-arm study utilizing a 6 x 4 expansion design using daratumumab SC treatment for patients with refractory Autoimmune Hemolytic Anemia.
Primary Outcome
Monitor for safety by cataloging any infections, injection site reactions or systemic reactions and any other adverse events that occur during the study period. The investigator will also catalog all adverse events, to monitor for any unpredicted side effects in this new patient population, as judged by the treating provider.
Interventions
- DRUG Daratumumab / Hyaluronidase Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2022-03-21 |
| Est. Completion | 2024-09-21 |
| Phase | Phase 1 |
What the finished NCT05004259 record still lists
NCT05004259 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Daratumumab / Hyaluronidase Injection is the first listed.
NCT05004259 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05004259 about?
NCT05004259 is a clinical study titled "The Safety of Repurposing Daratumumab for Relapsed or Refractory Autoimmune Antibody Mediated Hemolytic Anemia". A single-arm study utilizing a 6 x 4 expansion design using daratumumab SC treatment for patients with refractory Autoimmune Hemolytic Anemia.
What is the current status of trial NCT05004259?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2022-03-21. Estimated completion is 2024-09-21.
What interventions are being tested in trial NCT05004259?
The interventions under investigation include: Daratumumab / Hyaluronidase Injection (DRUG).
Who is sponsoring clinical trial NCT05004259?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05004259's enrollment target sits among peer trials
2 2000th of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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