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COMPLETED Phase 1

BioRBC Survival in Adults With Prior Antibody Response to BioRBCs

NCT02077751 · View on ClinicalTrials.gov ↗

Study Summary

Objective: To gather safety and efficacy BioRBC data from adult subjects who previously developed transient BioRBC antibody responses by redosing them and observing for adverse clinical or laboratory (i.e., a positive BioRBC antibody titer) outcomes to determine if RBC kinetic study results differ from the previous study. Hypothesis: BioRBC survival studies performed in adult subjects who previously developed a transient BioRBC antibody response will: 1) be associated with no adverse clinical or laboratory events; 2) experience a second transient, BioRBC antibody response; and 3) display a pattern of RBC survival that is identical to their prior dosing with BioRBCs at the same dose.

Conditions Studied

Interventions

  • DRUG biotin labelled RBCs

Study Locations (1)

Iowa

  • University of Iowa — Iowa City

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2013-05
Est. Completion 2019-12
Phase Phase 1

Sponsor

John A Widness

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02077751

The ClinicalTrials.gov registry entry for NCT02077751 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is John A Widness, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Anemia appearing as the primary indexed condition, and to 1 intervention — of which biotin labelled RBCs is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02077751 reports 1 study location spanning 1 distinct geographic area — top geographies include Iowa. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02077751 about?

NCT02077751 is a clinical study titled "BioRBC Survival in Adults With Prior Antibody Response to BioRBCs". Objective: To gather safety and efficacy BioRBC data from adult subjects who previously developed transient BioRBC antibody responses by redosing them and observing for adverse clinical or laboratory (i.e., a positive BioRBC antibody titer) outcomes to determine if RBC kinetic study results differ f...

What is the current status of trial NCT02077751?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2013-05. Estimated completion is 2019-12.

What conditions does trial NCT02077751 study?

This clinical trial studies the following conditions: Anemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02077751?

The interventions under investigation include: biotin labelled RBCs (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02077751?

This trial is sponsored by John A Widness, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02077751 being conducted?

This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial