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NCT04294043 · ClinicalTrials.gov registry record · Phase 1
IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study)
A Phase 1 study of Nontuberculous Mycobacterium Infection, sponsored by Chris Goss.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 10
- Study locations
NCT04294043: Recruiting Phase 1 study of Nontuberculous Mycobacterium Infection, sponsored by Chris Goss.
NCT04294043 is a Phase 1 study of Nontuberculous Mycobacterium Infection that is actively recruiting participants, run by Chris Goss. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). The trial reports 10 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04294043, a Phase 1 study of Nontuberculous Mycobacterium Infection, is actively recruiting participants, sponsored by Chris Goss.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 10
- Study locations
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)
Primary Outcome
Proportion of patients experiencing one or more Adverse Events of Special Interest (AESI). AESIs include the occurrence of either (1) a serious adverse event (SAE) of grade 3 or higher including hospitalizations or (2) study drug discontinuation because of an AE.
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 |
What NCT04294043 shows while recruiting
NCT04294043 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
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.
NCT04294043 lists 10 locations in 10 states (Alabama, Colorado, Maryland).
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.
What interventions are being tested in trial NCT04294043?
The interventions under investigation include: Gallium nitrate (DRUG).
Who is sponsoring clinical trial NCT04294043?
This trial is sponsored by Chris Goss, which has 6 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Nontuberculous Mycobacterium Infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04294043's enrollment target sits among peer trials
40 1131st of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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