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IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study)
NCT04294043 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG Gallium nitrate
Study Locations (10)
Alabama
- University of Alabama at Birmingham — Birmingham
Colorado
- National Jewish Health — Denver
Maryland
- Johns Hopkins University — Baltimore
Minnesota
- The Minnesota Cystic Fibrosis Center — Minneapolis
Ohio
- Nationwide Children's Hospital — Columbus
Pennsylvania
- University of Pittsburgh Medical Center — Pittsburgh
South Carolina
- Medical University of South Carolina — Charleston
Texas
- University of Texas Southwestern — Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2021-06-17 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04294043
The ClinicalTrials.gov registry entry for NCT04294043 describes a study currently listed as recruiting. 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 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Chris Goss, which has 2 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 Nontuberculous Mycobacterium Infection appearing as the primary indexed condition, and to 1 intervention — of which Gallium nitrate 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: NCT04294043 reports 10 study locations spanning 10 distinct geographic areas — top geographies include Alabama, Colorado, Maryland. 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 NCT04294043 about?
NCT04294043 is a clinical study titled "IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study)". 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)
What is the current status of trial NCT04294043?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2021-06-17. Estimated completion is 2027-03-31.
What conditions does trial NCT04294043 study?
This clinical trial studies the following conditions: Nontuberculous Mycobacterium Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04294043?
The interventions under investigation include: Gallium nitrate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04294043?
This trial is sponsored by Chris Goss, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04294043 being conducted?
This trial has 10 study locations across Alabama, Colorado, Maryland, Minnesota, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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