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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.
 
ClinicalTrials.gov Identifier: NCT04294043
Recruitment Status : Recruiting
First Posted : March 3, 2020
Last Update Posted : January 12, 2023
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Chris Goss, Seattle Children's Hospital

Tracking Information
First Submitted Date  ICMJE March 1, 2020
First Posted Date  ICMJE March 3, 2020
Last Update Posted Date January 12, 2023
Actual Study Start Date  ICMJE June 17, 2021
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2020)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2020)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study)
Official Title  ICMJE 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)
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
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Nontuberculous Mycobacterium Infection
Intervention  ICMJE Drug: Gallium nitrate
Study subjects will receive an infusion of gallium nitrate.
Other Names:
  • Ga
  • GaN3O9
  • IV gallium
  • ganite
Study Arms  ICMJE 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.
Intervention: Drug: Gallium nitrate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 1, 2020)		 40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2025
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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. 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., 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Natallia Cameron 206-884-7550 Natallia.Cameron@seattlechildrens.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04294043
Other Study ID Numbers  ICMJE ABATE-IP-18
R01FD006848 ( U.S. FDA Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Chris Goss, Seattle Children's Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Chris Goss
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Cystic Fibrosis Foundation
Investigators  ICMJE
Principal Investigator: Christopher H. Goss, MD, MSc University of Washington, Seattle Children's Hospital
PRS Account Seattle Children's Hospital
Verification Date January 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP