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NCT05758493 · ClinicalTrials.gov registry record · Phase 2

Characterizing Iodine-124 Evuzumitide (AT-01) in Systemic Amyloidosis

A Phase 2 study of Amyloidosis and Transthyretin Amyloidosis, sponsored by Oregon Health and Science University.

Recruiting
Registry status
Phase 2
Development phase
150
Enrollment target
1
Study location

NCT05758493 is a Phase 2 study of Amyloidosis and Transthyretin Amyloidosis that is actively recruiting participants, run by Oregon Health and Science University. The registered enrollment target is 150 participants, below the 1,123-participant average among 28 other Amyloidosis trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05758493, a Phase 2 study of Amyloidosis and Transthyretin Amyloidosis, is actively recruiting participants, sponsored by Oregon Health and Science University.

RECRUITING
Registry status
Phase 2
Development phase
150 participants
Enrollment target
1
Study location

Study Summary

This is a single center prospective study evaluating 124I-evuzumitide in patients with systemic amyloidosis. The purpose of this study is to 1)identify and characterize the distribution and uptake of 124I-evuzumitide in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) and 2) Correlate the uptake with the structure and function of different organs, including the heart. To achieve these goals, eligible patients will undergo primarily hybrid positron emission tomography and magnetic resonance imaging (PET/MRI). In a subgroup of patients who are unable to undergo PET/MR, computed tomography will be used instead of MRI (i.e. PET/CT). In a subgroup of patients, repeat imaging with the same modality will be done at a interval of 6-12 months. Clinically available data (demographics, phenotype, imaging, laboratory) will also be collected to characterize the disease in each patient.

Interventions

  • DIAGNOSTIC_TEST 124I-Evuzamitide

Study Locations (1)

Oregon

  • Oregon Health & Science University - Portland

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2023-01-10
Est. Completion 2028-03-10
Phase Phase 2

What the Registry Record Tells You About NCT05758493

The ClinicalTrials.gov registry entry for NCT05758493 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,123-participant average among 28 other Amyloidosis trials with a reported enrollment target (87% lower). The listed sponsor is Oregon Health and Science University, which has 546 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Amyloidosis appearing as the primary indexed condition, and to 1 intervention - of which 124I-Evuzamitide is the first listed.

NCT05758493 reports 1 study location spanning 1 distinct geographic area - top geographies include Oregon.

Frequently Asked Questions

What is clinical trial NCT05758493 about?

NCT05758493 is a clinical study titled "Characterizing Iodine-124 Evuzumitide (AT-01) in Systemic Amyloidosis". This is a single center prospective study evaluating 124I-evuzumitide in patients with systemic amyloidosis. The purpose of this study is to 1)identify and characterize the distribution and uptake of 124I-evuzumitide in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) and 2) Correlate th...

What is the current status of trial NCT05758493?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2023-01-10. Estimated completion is 2028-03-10.

What conditions does trial NCT05758493 study?

This clinical trial studies the following conditions: Amyloidosis, Transthyretin Amyloidosis.

What interventions are being tested in trial NCT05758493?

The interventions under investigation include: 124I-Evuzamitide (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT05758493?

This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05758493 being conducted?

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

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

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