RecruitingPhase 1NCT04294043

IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study)

A Phase 1b, Multi-center Study of Intravenous (IV) Gallium Nitrate in Patients With Cystic Fibrosis (CF) Who Are Colonized With Nontuberculous Mycobacteria (NTM) (The ABATE Study)


Sponsor

Chris Goss

Enrollment

40 participants

Start Date

Jun 17, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to assess the safety and tolerability of two 5-day infusion cycles of IV gallium in adult patients with CF who are infected with NTM. Funding Source - FDA Office of Orphan Products Development (OOPD)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Gallium nitrate for people with nontuberculous mycobacterium infection. The study is currently recruiting participants at 10 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGallium nitrate

Study subjects will receive an infusion of gallium nitrate.


Locations(10)

University of Alabama at Birmingham

Birmingham, Alabama, United States

National Jewish Health

Denver, Colorado, United States

Johns Hopkins University

Baltimore, Maryland, United States

The Minnesota Cystic Fibrosis Center

Minneapolis, Minnesota, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

University of Texas Southwestern

Dallas, Texas, United States

University of Vermont Medical Center

Burlington, Vermont, United States

University of Washington Medical Center

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT04294043


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