Health TrialsbyHealthPanel

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

ConditionNontuberculous Mycobacterium Infection
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Gallium nitrate

    Drug

    Study subjects will receive an infusion of gallium nitrate.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Infusion of IV GalliumExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse Events of Special Interest

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.

Time frame
Baseline to Day 57

Secondary outcomes

1

Clinically significant abnormal laboratory measures. (safety)

Proportion of patients experiencing clinically significant abnormal laboratory measures. Clinically significant abnormal laboratory measures are identified by the site investigator.

Time frame
Baseline to Day 57
2

NTM clearance (efficacy)

Proportion of subjects who were NTM culture positive at baseline and have at least 2 sequential negative NTM cultures between visits 2 (Day 6) and 7 (Day 111). Those negative cultures must be at least 2 weeks apart.

Time frame
Day 6 to Day 111

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chris Goss

Lead sponsor

Seattle Children's Hospital

Sponsor institution

Cystic Fibrosis Foundation

Collaborator

Source ClinicalTrials.gov
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