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ABATE-IP-18: A Phase 1b, Multi-center Study of IV Gallium Nitrate in Patients with Cystic Fibrosis who are Colonized with Nontuberculous Mycobacteria (The ABATE Study)

Recruiting

The purpose of this research study is to test the safety of giving two separate 5-day infusions (starting on Day 1 and again around Day 15) through a vein with a drug called gallium nitrate. Laboratory tests suggest that this drug may be able to fight Nontuberculous Mycobacteria (NTM) infections

I'm interested
Visit the Study Website

Male or Female
18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of cystic fibrosis
• persistent Nontuberculous Mycobacterium lung infection (NTM)
• able to expectorate sputum
• enrolled in the CFF Patient Registry
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• history of solid organ or hematological transplantation
• current diagnosis of osteoporosis
• women who are pregnant or breast feeding
• men and women who are unwilling to practice a medically acceptable form of contraception

Drug: Gallium nitrate

Rare Diseases, Breathing, Lung & Sleep Health

CF, Cystic Fibrosis, Nontuberculous Mycobacterium Infection, NTM

Cystic Fibrosis Research Team Study - cftrials@umn.edu
Joanne Billings
PHASE1
STUDY00020585
See this study on ClinicalTrials.gov

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