Ignite Creation Date:
2024-05-06 @ 2:21 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04294043
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2020-03-01
Brief Title:
IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM ABATE Study
Sponsor:
Chris Goss
Organization:
Seattle Childrens Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ABATE
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 Office of Orphan Products Development OOPD
Funding Source - FDA Office of Orphan Products Development OOPD
Detailed Description:
This is a prospective multicenter open-label study in adults with CF who are colonized with M avium complex andor 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01FD006848 | FDA | None | httpsreporternihgovquickSearchR01FD006848 |