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NCT03364686 · ClinicalTrials.gov registry record · Phase 2

Transfusion of Biotin-Labeled Red Blood Cells

A Phase 2 study, sponsored by Gladwin, Mark, MD.

Terminated
Registry status
Phase 2
Development phase
6
Enrollment target

NCT03364686: Clinical Trial Phase 2 study, sponsored by Gladwin, Mark, MD.

NCT03364686 is a Phase 2 study that was terminated before completion, run by Gladwin, Mark, MD. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03364686, a Phase 2 study, was terminated before completion, sponsored by Gladwin, Mark, MD.

TERMINATED
Registry status
Phase 2
Development phase
6 participants
Enrollment target

Study Summary

The purpose of this research is to evaluate the impact of genetic and biologic factors in blood donors on red blood cell storage stability after autologous transfusion over the different range of storage period of 5-7 days and 35-42 days in healthy volunteers.

Primary Outcome

This will be determined using enumeration of biotinylated red blood cells obtained by flow cytometry from blood samples obtained at various time points from subjects with specified genetic mutations, compared with control subjects without the specified mutation. Percentage of Biotin Labeled Red Blood Cells is determined by Biotin Labeled Red Blood Cells in circulation at each time point/baseline Biotin Labeled Red Blood Cells in circulation x 100.

Interventions

  • BIOLOGICAL Biotin-Labeled Red Blood Cells

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2019-09-16
Est. Completion 2021-06-29
Phase Phase 2
Gladwin, Mark, MD

11 total trials

Why NCT03364686 stopped before completion

NCT03364686 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 1 intervention - of which Biotin-Labeled Red Blood Cells is the first listed.

NCT03364686 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03364686 about?

NCT03364686 is a clinical study titled "Transfusion of Biotin-Labeled Red Blood Cells". The purpose of this research is to evaluate the impact of genetic and biologic factors in blood donors on red blood cell storage stability after autologous transfusion over the different range of storage period of 5-7 days and 35-42 days in healthy volunteers.

What is the current status of trial NCT03364686?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2019-09-16. Estimated completion is 2021-06-29.

What interventions are being tested in trial NCT03364686?

The interventions under investigation include: Biotin-Labeled Red Blood Cells (BIOLOGICAL).

Who is sponsoring clinical trial NCT03364686?

This trial is sponsored by Gladwin, Mark, MD, which has 11 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03364686's enrollment target sits among peer trials

6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT03364686, the US trial registry maintained by the National Library of Medicine. NCT03364686 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.