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NCT02865434 · ClinicalTrials.gov registry record · Phase 1
Evaluating Safety of Escalating Doses of Tilmanocept by IV Injection and SPECT Imaging in Subjects With and Without RA
A Phase 1 study of Arthritis, Rheumatoid, sponsored by Navidea Biopharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
- 1
- Study location
NCT02865434: Completed Phase 1 study of Arthritis, Rheumatoid, sponsored by Navidea Biopharmaceuticals.
NCT02865434 is a Phase 1 study of Arthritis, Rheumatoid that has completed, run by Navidea Biopharmaceuticals. The registered enrollment target is 39 participants, below the 640-participant average among 27 other Arthritis, Rheumatoid trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02865434, a Phase 1 study of Arthritis, Rheumatoid, has completed, sponsored by Navidea Biopharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
- 1
- Study location
Study Summary
Prospective, open-label, multicenter, dose escalation, safety with pharmacokinetics (PK) and dosimetry study of injected Tc 99m tilmanocept in the detection of and assessment of localization to skeletal joints in subjects with and without active RA by SPECT imaging.
Primary Outcome
Number of participants that experienced pharmacologic activity or ADR in each dose group.
Conditions Studied
Interventions
- DRUG Tc99m-tilmanocept
- PROCEDURE SPECT Imaging (60 Minutes post-injection)
- PROCEDURE SPECT Imaging (180 Minutes post-injection)
- PROCEDURE Whole body planar SPECT imaging (15 Minutes post-injection)
- PROCEDURE Whole body planar SPECT imaging (60 Minutes post-injection)
Study Locations (1)
Ohio
- Kettering Medical Center - Kettering
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2017-01 |
| Est. Completion | 2018-06 |
| Phase | Phase 1 |
What the finished NCT02865434 record still lists
NCT02865434 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 640-participant average among 27 other Arthritis, Rheumatoid trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Arthritis, Rheumatoid appearing as the primary indexed condition, and to 5 interventions - of which Tc99m-tilmanocept is the first listed.
NCT02865434 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT02865434 about?
NCT02865434 is a clinical study titled "Evaluating Safety of Escalating Doses of Tilmanocept by IV Injection and SPECT Imaging in Subjects With and Without RA". Prospective, open-label, multicenter, dose escalation, safety with pharmacokinetics (PK) and dosimetry study of injected Tc 99m tilmanocept in the detection of and assessment of localization to skeletal joints in subjects with and without active RA by SPECT imaging.
What is the current status of trial NCT02865434?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2017-01. Estimated completion is 2018-06.
What conditions does trial NCT02865434 study?
This clinical trial studies the following conditions: Arthritis, Rheumatoid.
What interventions are being tested in trial NCT02865434?
The interventions under investigation include: Tc99m-tilmanocept (DRUG), SPECT Imaging (60 Minutes post-injection) (PROCEDURE), SPECT Imaging (180 Minutes post-injection) (PROCEDURE), Whole body planar SPECT imaging (15 Minutes post-injection) (PROCEDURE), Whole body planar SPECT imaging (60 Minutes post-injection) (PROCEDURE).
Who is sponsoring clinical trial NCT02865434?
This trial is sponsored by Navidea Biopharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02865434 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02865434's enrollment target sits among peer trials
39 25th of 27 higher than 3 of 27 other Arthritis, Rheumatoid trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Arthritis, Rheumatoid 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.
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