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

January 10, 2024 updated by: Chris Goss

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)

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
    • Colorado
      • Denver, Colorado, United States, 80206
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • Johns Hopkins University
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Not yet recruiting
        • The Minnesota Cystic Fibrosis Center
        • Contact:
    • Ohio
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
    • Texas
    • Vermont
      • Burlington, Vermont, United States, 05401
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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. All sexes ≥ 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.

  5. 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:

    1. The two most recent NTM culture results from sputum or bronchoalveolar lavage (BAL) taken at least 28 days apart are positive.

      OR

    2. 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.
  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 at one 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 Patient Registry (CFF PR)
  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
    • Absolute neutrophil count < 1500/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 (e.g., cystic fibrosis transmembrane conductance regulator (CFTR) modulators, ibuprofen, azithromycin, inhaled tobramycin, Cayston, etc.) within 28 days prior to Visit 1 (Day 1)
  13. Use of azithromycin within 14 days prior to the screening visit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to Day 57

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to Day 57
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.
Day 6 to Day 111

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chris Goss

Collaborators

Cystic Fibrosis Foundation

Investigators

  • Principal Investigator: Christopher H. Goss, MD, MSc, University of Washington, Seattle Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2021

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

March 1, 2020

First Submitted That Met QC Criteria

March 1, 2020

First Posted (Actual)

March 3, 2020

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABATE-IP-18
  • R01FD006848 (U.S. FDA Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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