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

NCT04294043 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-10-01

No results posted yet for this study

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)

Conditions

  • Nontuberculous Mycobacterium Infection

Interventions

DRUG

Gallium nitrate

Study subjects will receive an infusion of gallium nitrate.

Sponsors & Collaborators

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • Chris Goss

    lead OTHER

Principal Investigators

  • Christopher H. Goss, MD, MSc · University of Washington, Seattle Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-17
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04294043 on ClinicalTrials.gov