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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Chris Goss
Study ID
NCT04294043
Phase
PHASE1
Status
Recruiting
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Conditions

  • Nontuberculous Mycobacterium Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gallium nitrate — DRUG
    Study subjects will receive an infusion of gallium nitrate.

Study Details

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)

Key Dates

Start date
Jun 17, 2021
Status verified
Sep 2025
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Infusion of IV Gallium
    Gallium nitrate will be infused continuously over 5 days at 200 mg/m2/day. Study drug will be administered via a peripheral IV catheter, a peripherally inserted central catheter (PICC) line, midline catheter, or a chronic indwelling vascular access device using an ambulatory infusion pump infused over 24 hours for 5 sequential days for each cycle. There is a maximum of 2 cycles.

Primary Outcome Measure

Adverse Events of Special Interest [ Time Frame: Baseline to Day 57 ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Kathryn Monroe
[email protected]
2056385599
National Jewish HealthDenverColorado80206
Johns Hopkins UniversityBaltimoreMaryland21205
Jeanne Pinto
[email protected]
The Minnesota Cystic Fibrosis CenterMinneapolisMinnesota55455
CF Trials Contact
[email protected]
Nationwide Children's HospitalColumbusOhio43205
Diana Gilmore
[email protected]
University of Pittsburgh Medical CenterPittsburghPennsylvania15224
Adrienne DeRicco
[email protected]
Medical University of South CarolinaCharlestonSouth Carolina29425
Ashley Warden
[email protected]
University of Texas SouthwesternDallasTexas75390
Ashley Keller
[email protected]
University of Vermont Medical CenterBurlingtonVermont05401
University of Washington Medical CenterSeattleWashington98195
Lauren Bartlett
[email protected]

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALNational Jewish Health· Denver, COJohns Hopkins University· Baltimore, MDThe Minnesota Cystic Fibrosis Center· Minneapolis, MNNationwide Children's Hospital· Columbus, OHUniversity of Pittsburgh Medical Center· Pittsburgh, PA

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