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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04294043
Recruitment Status : Recruiting
First Posted : March 3, 2020
Last Update Posted : March 10, 2022
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Chris Goss, Seattle Children's Hospital

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 OOPD

Condition or disease Intervention/treatment Phase
Nontuberculous Mycobacterium Infection Drug: Gallium nitrate Phase 1

Detailed Description:

This is a prospective, multicenter open-label study in adults with CF who are colonized with M. avium complex and/or M. abscessus complex.

Subjects will receive two 5-day infusion cycles of IV gallium. The study will evaluate the safety and antimycobacterial effect of two 5-day infusions of IV gallium.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b, Multi-center Study of Intravenous (IV) Gallium Nitrate in Patients With Cystic Fibrosis (CF) Who Are Colonized With Nontuberculous Mycobacteria (NTM) (The ABATE Study)
Actual Study Start Date : June 17, 2021
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2024

Arm Intervention/treatment
Experimental: Infusion of IV Gallium
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
Study subjects will receive an infusion of gallium nitrate.
Other Names:
  • Ga
  • GaN3O9
  • IV gallium
  • ganite

Primary Outcome Measures :
  1. Adverse Events of Special Interest [ Time Frame: Baseline to Day 57 ]
    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.

Secondary Outcome Measures :
  1. Clinically significant abnormal laboratory measures. (safety) [ Time Frame: Baseline to Day 57 ]
    Proportion of patients experiencing clinically significant abnormal laboratory measures. Clinically significant abnormal laboratory measures are identified by the site investigator.

  2. NTM clearance (efficacy) [ Time Frame: Day 6 to Day 111 ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Written informed consent obtained from subject or subject's legal representative
  2. Be willing and able to adhere to the study visit schedule and other protocol requirements
  3. Greater than or equal to 18 years of age at Visit 1
  4. Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:

    • Sweat chloride ≥ 60 milliequivalent (mEq)/liter by quantitative pilocarpine iontophoresis test (QPIT)
    • Two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
    • Abnormal nasal potential difference (NPD) (change in NPD in response to a low chloride solution and isoproteronol of less than -5 mV)
  5. Documentation of NTM culture positive defined as follows:

    • Two positive NTM culture results from sputum (or BAL) at least 28 days apart (these are the two qualifying positive cultures)
    • Both qualifying positive culture results include M. avium complex, M. abscessus complex, or both M. avium and M. abscessus
    • Both qualifying positive culture results include the same species or subspecies
    • No cultures negative for NTM since the first of the two qualifying positive culture results
  6. 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
  7. Forced expiratory volume in 1 second (FEV1) ≥ 25 % of predicted value at Screening
  8. Able to expectorate sputum
  9. Clinically stable with no significant changes in health status within 7 days prior to Day 1
  10. Enrolled in the CFF Cystic Fibrosis Foundation Patient Registry (CFFPR)
  11. Willing to discontinue chronic azithromycin use for the duration of the study

Exclusion Criteria:

  1. Any of the following abnormal lab values at screening:

    • Hemoglobin <10g/dL
    • Platelets <100,000/mm3
    • White blood cells (WBC) < 4,500/mm3
    • Aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transferase (GGT), or alkaline phosphatase (ALP) ≥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)
  2. History of solid organ or hematological transplantation
  3. Use of bisphosphonates within 7 days prior to Day 1
  4. Known sensitivity to gallium
  5. Use of any investigational drug and/or participated in any interventional clinical trial within 28 days prior to Day 1
  6. 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)
  7. Undergoing treatment for NTM disease or anticipate beginning treatment within 3 months
  8. Current diagnosis of osteoporosis
  9. For people of childbearing potential:

    • Positive pregnancy test at Visit 1 or
    • Lactating or
    • Unwilling to practice a medically acceptable form of contraception (acceptable forms of contraception: abstinence, hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent), unless surgically sterilized or postmenopausal during the study
  10. For people able to father a child: unwilling to use adequate contraception (as determined by the investigator) during the study
  11. Has any other condition that, in the opinion of the Site Investigator/designee, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
  12. New initiation of chronic therapy (greater than 21 days) within 28 days prior to the Enrollment Visit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04294043

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Contact: Lauren Braam, MIH 206-884-1487

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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Justin Wade   
United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Alix Wilson   
United States, Florida
University of Florida Not yet recruiting
Gainesville, Florida, United States, 32610
Contact: Noni Graham   
United States, Maryland
Johns Hopkins University Not yet recruiting
Baltimore, Maryland, United States, 21205
Contact: Britany Zeglin   
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Diana Gilmore   
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Elizabeth Hartigan   
United States, South Carolina
Medical University of South Carolina Not yet recruiting
Charleston, South Carolina, United States, 29425
Contact: Ashley Warden   
United States, Texas
University of Texas Southwestern Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Ashley Keller   
United States, Vermont
University of Vermont Medical Center Recruiting
Burlington, Vermont, United States, 05401
Contact: Julie Sweet   
United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Teresa Gambol   
Sponsors and Collaborators
Chris Goss
Cystic Fibrosis Foundation
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Principal Investigator: Christopher H. Goss, MD, MSc University of Washington, Seattle Children's Hospital
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Responsible Party: Chris Goss, Professor of Medicine and Pediatrics, University of Washington, Seattle Children's Hospital Identifier: NCT04294043    
Other Study ID Numbers: ABATE-IP-18
R01FD006848 ( U.S. FDA Grant/Contract )
First Posted: March 3, 2020    Key Record Dates
Last Update Posted: March 10, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chris Goss, Seattle Children's Hospital:
Cystic Fibrosis
Gallium Nitrate
IV Gallium
Nontuberculous mycobacterium
Mycobacterium abscessus
mycobacterium avium
Additional relevant MeSH terms:
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Mycobacterium Infections
Mycobacterium Infections, Nontuberculous
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Gallium nitrate
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antineoplastic Agents