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NCT02380924 · ClinicalTrials.gov registry record · Phase 1
Recovery and Survival of EryDex in Non-patient Volunteers
A Phase 1 study of Healthy, sponsored by Quince Therapeutics S.p.A..
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT02380924: Completed Phase 1 study of Healthy, sponsored by Quince Therapeutics S.p.A..
NCT02380924 is a Phase 1 study of Healthy that has completed, run by Quince Therapeutics S.p.A.. The registered enrollment target is 10 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02380924, a Phase 1 study of Healthy, has completed, sponsored by Quince Therapeutics S.p.A..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized, single-blind, single-center, concurrently controlled, exploratory, Phase I study to determine the in vivo kinetics (24-hour post-infusion recovery and T50 survival) of EryDex System (EDS) -processed autologous red blood cells (RBC) in non-patient volunteers. A total of 12 non-patient volunteer subjects will be enrolled and assigned to one of the 2 groups (6 subjects in active arm group, 6 subjects in sham arm group).
Primary Outcome
The 24-hour recovery of autologous RBCs loaded with DSP or sham using the EDS will be greater than 75% with 95% confidence. For RBC kinetics and recovery will be reported as mean, 2-sided 95% CI on the mean, standard deviation, minimum and maximum.
Conditions Studied
Interventions
- DRUG DSP loaded RBC using EryDex System
- DRUG Sham treated RBC using the EryDex System
Study Locations (1)
New Hampshire
- Dartmouth-Hitchcock Medical Center - Lebanon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2015-01 |
| Est. Completion | 2015-06 |
| Phase | Phase 1 |
What the finished NCT02380924 record still lists
NCT02380924 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which DSP loaded RBC using EryDex System is the first listed.
NCT02380924 reports a single indexed study location in New Hampshire.
Frequently Asked Questions
What is clinical trial NCT02380924 about?
NCT02380924 is a clinical study titled "Recovery and Survival of EryDex in Non-patient Volunteers". This is a randomized, single-blind, single-center, concurrently controlled, exploratory, Phase I study to determine the in vivo kinetics (24-hour post-infusion recovery and T50 survival) of EryDex System (EDS) -processed autologous red blood cells (RBC) in non-patient volunteers. A total of 12 non-p...
What is the current status of trial NCT02380924?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2015-01. Estimated completion is 2015-06.
What conditions does trial NCT02380924 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT02380924?
The interventions under investigation include: DSP loaded RBC using EryDex System (DRUG), Sham treated RBC using the EryDex System (DRUG).
Who is sponsoring clinical trial NCT02380924?
This trial is sponsored by Quince Therapeutics S.p.A., which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02380924 being conducted?
This trial has 1 study location across New Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02380924's enrollment target sits among peer trials
10 1035th of 1090 higher than 35 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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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