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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)
Status: 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
Sex: Male or Female
Age Group: 18 years and over
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
Conditions:
Rare Diseases, Breathing, Lung & Sleep Health
Keywords:
CF, Cystic Fibrosis, Nontuberculous Mycobacterium Infection, NTM
Study Contact: Cystic Fibrosis Research Team Study - cftrials@umn.edu
Principal Investigator: Joanne Billings
Phase: PHASE1
IRB Number: STUDY00020585
See this study on ClinicalTrials.gov