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NCT03157167 · ClinicalTrials.gov registry record · Phase 1
An Evaluation of Tc 99m Tilmanocept by Intravenous (IV) and Subcutaneous (SC) Injection in Kaposi Sarcoma (KS)
A Phase 1 study, sponsored by Navidea Biopharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT03157167: Completed Phase 1 study, sponsored by Navidea Biopharmaceuticals.
NCT03157167 is a Phase 1 study that has completed, run by Navidea Biopharmaceuticals. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03157167, a Phase 1 study, has completed, sponsored by Navidea Biopharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
To determine the safety of escalating IV doses of Tc 99m tilmanocept in HIV (human immunodeficiency virus) subjects with confirmed KS and to compare results obtained from subcutaneous and IV administrations of Tc 99m tilmanocept in the same subjects.
Primary Outcome
Cohort 1 (100 mcg/ 5mCi) was conducted first. A safety data review meeting was held after completion of Cohort 1 and again after completion of Cohort 2 at which the principal investigators and sponsor representatives reviewed the safety data to determine whether to proceed to the next cohort. All cohorts were evaluated for safety. Safety evaluations included AEs, clinical laboratory tests, vital signs, physical examinations, and ECGs. The data table includes the number of safety signals detect
Interventions
- DRUG Tc99m-tilmanocept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2017-12-01 |
| Est. Completion | 2020-03-30 |
| Phase | Phase 1 |
What the finished NCT03157167 record still lists
NCT03157167 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which Tc99m-tilmanocept is the first listed.
NCT03157167 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03157167 about?
NCT03157167 is a clinical study titled "An Evaluation of Tc 99m Tilmanocept by Intravenous (IV) and Subcutaneous (SC) Injection in Kaposi Sarcoma (KS)". To determine the safety of escalating IV doses of Tc 99m tilmanocept in HIV (human immunodeficiency virus) subjects with confirmed KS and to compare results obtained from subcutaneous and IV administrations of Tc 99m tilmanocept in the same subjects.
What is the current status of trial NCT03157167?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2017-12-01. Estimated completion is 2020-03-30.
What interventions are being tested in trial NCT03157167?
The interventions under investigation include: Tc99m-tilmanocept (DRUG).
Who is sponsoring clinical trial NCT03157167?
This trial is sponsored by Navidea Biopharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03157167's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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