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

NCT04294043 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: ABATE-IP-18R01FD006848
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 10

Brief Summary

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)

Conditions

Nontuberculous Mycobacterium Infection

Keywords

Cystic Fibrosis; Gallium Nitrate; IV Gallium; Nontuberculous mycobacterium; NTM; Mycobacterium abscessus; mycobacterium avium

Outcome Measures

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.

  Baseline to Day 57

Secondary Outcomes (2)

• Clinically significant abnormal laboratory measures. (safety)

  Baseline to Day 57

• NTM clearance (efficacy)

  Day 6 to Day 111

Study Arms (1)

Infusion of IV Gallium

EXPERIMENTAL

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.

Drug: Gallium nitrate

Interventions

Gallium nitrate DRUG

Study subjects will receive an infusion of gallium nitrate.

Also known as: Ga, GaN3O9, IV gallium, ganite

Infusion of IV Gallium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Documentation of persistently positive NTM culture results that are positive for the same species or sub-species (either M. avium complex, M. abscessus complex, or both M. avium and M. abscessus). Persistently positive cultures are those which meet ONE of the following criteria, after first ignoring any negative culture results that occur within 7 days of a positive culture:
• The two most recent NTM culture results from sputum or BAL taken at least 28 days apart are positive.
• At least one NTM culture result in the previous 4 months from sputum or BAL is positive. If there are four or more cultures in the last 12-months at least 3 out of the 4 most recent cultures must be positive for NTM. If there are three or fewer cultures in the past 12 months, then at least 2 of the 3 most recent cultures must be positive for NTM even if some of those cultures are more than 12 months ago.
• Current NTM species or subspecies has never been treated or previous treatment was associated with clearance of NTM and completed \> 2 years prior to Day 1
• FEV1 ≥ 25 % of predicted value at Screening
• Able to expectorate sputum
• Clinically stable with no significant changes in health status within 7 days prior to Day 1
• Enrolled in the CFF Patient Registry (CFF PR)
• Willing to discontinue chronic azithromycin use for the duration of the study
• 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

You may not qualify if:

• Any of the following abnormal lab values at screening:
• 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
• Serum creatinine \> 2.0 mg/dl and ≥1.5 x upper limit of normal
• Ionized calcium ≤ lower limit of normal (only performed if total calcium is ≤ lower limit of normal)
• History of solid organ or hematological transplantation
• Use of bisphosphonates within 7 days prior to Day 1
• Known sensitivity to gallium
• Use of any investigational drug and/or participated in any interventional clinical trial within 28 days prior to Day 1
• In the opinion of the Investigator, features of active NTM disease are present (e.g., clinical worsening is likely due to NTM disease despite definitive treatment of co-pathogens and/or acute exacerbations)
• Undergoing treatment for NTM disease or anticipate beginning treatment within 3 months
• Current diagnosis of osteoporosis
• For people of childbearing potential:

Sponsors & Collaborators

• Chris Goss: lead
• Cystic Fibrosis Foundation: collaborator

Study Sites (10)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

National Jewish Health

Denver, Colorado, 80206, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21205, United States

RECRUITING

The Minnesota Cystic Fibrosis Center

Minneapolis, Minnesota, 55455, United States

RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

University of Texas Southwestern

Dallas, Texas, 75390, United States

RECRUITING

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

RECRUITING

University of Washington Medical Center

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Mycobacterium Infections, Nontuberculous; Cystic Fibrosis; Mycobacterium avium-intracellulare Infection

Interventions

gallium nitrate; Gallium

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Metals

Study Officials

• Christopher H. Goss, MD, MSc

  University of Washington, Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natallia Cameron

CONTACT

206-884-7550; Natallia.Cameron@seattlechildrens.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine and Pediatrics, University of Washington

Study Record Dates

• First Submitted: March 1, 2020
• First Posted: March 3, 2020
• Study Start: June 17, 2021
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)