IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorChris Goss
About this trial
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)
Eligibility criteria
Qualifiers
Written informed consent obtained from participant or participant's legal representative
Be willing and able to adhere to the study visit schedule and other protocol requirements
All genders ≥ 18 years of age at Visit 1
Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype
Disqualifiers
Hemoglobin <10g/dL
Platelets <100,000/mm3
Absolute neutrophil count < 1500/mm3
Aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), or total bilirubin ≥3 x upper limit of normal
Trial design
Treatments tested in this trial
- Gallium nitrate
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Chris Goss
Lead sponsor
Seattle Children's Hospital
Sponsor institution
Cystic Fibrosis Foundation
Collaborator
Source ClinicalTrials.gov