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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2024
  • participants needed
    40
  • sponsor
    Chris Goss
Updated on 15 March 2022

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

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.

Details
Condition Nontuberculous Mycobacterium Infection
Treatment Gallium nitrate
Clinical Study IdentifierNCT04294043
SponsorChris Goss
Last Modified on15 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Written informed consent obtained from subject or subject's legal representative
Be willing and able to adhere to the study visit schedule and other protocol requirements
Greater than or equal to 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 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)
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
Current NTM species or subspecies has never been treated or previous treatment was
Able to expectorate sputum
associated with clearance of NTM and completed > 2 years prior to Day 1
Forced expiratory volume in 1 second (FEV1) ≥ 25 % of predicted value at Screening
Clinically stable with no significant changes in health status within 7 days prior to Day 1
Enrolled in the CFF Cystic Fibrosis Foundation Patient Registry (CFFPR)
Willing to discontinue chronic azithromycin use for the duration of the study

Exclusion Criteria

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
History of solid organ or hematological transplantation
Ionized calcium ≤ lower limit of normal (only performed if total calcium is ≤ lower limit of normal)
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
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
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
New initiation of chronic therapy (greater than 21 days) within 28 days prior to the Enrollment Visit
For people able to father a child: unwilling to use adequate contraception (as
determined by the investigator) during the study
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