IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study) (ABATE)
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|ClinicalTrials.gov Identifier: NCT04294043|
Recruitment Status : Recruiting
First Posted : March 3, 2020
Last Update Posted : June 23, 2021
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|
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 (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT04294043
|Contact: Lauren Braam, MIHfirstname.lastname@example.org|
|United States, Colorado|
|National Jewish Health||Not yet recruiting|
|Denver, Colorado, United States, 80206|
|Contact: Alix Wilson email@example.com|
|United States, Washington|
|University of Washington Medical Center||Recruiting|
|Seattle, Washington, United States, 98195|
|Contact: Teresa Gambol TGambol@medicine.washington.edu|
|Principal Investigator:||Christopher H. Goss, MD, MSc||University of Washington, Seattle Children's Hospital|