IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study) (NCT04294043) | Clinical Trial Compass
RecruitingPhase 1
IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study)
United States40 participantsStarted 2021-06-17
Plain-language 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 Office of Orphan Products Development (OOPD)
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Written informed consent obtained from participant or participant's legal representative
✓. Be willing and able to adhere to the study visit schedule and other protocol requirements
✓. All genders ≥ 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
✓. 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:
✓. The two most recent NTM culture results from sputum or BAL taken at least 28 days apart are positive.
✓. 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.
✓. 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
Exclusion criteria
✕. Any of the following abnormal lab values at screening:
. History of solid organ or hematological transplantation
✕. 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