ENCORE - Study to Evaluate Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium avium Complex (MAC)
Enrolling By Invitation
18-99 years
All
Phase
3
5 participants needed
1 Location
Brief description of study
The purpose of this study is to evaluate the effect and safety of amikacin liposome inhalation suspension (ALIS) study treatment on patient-reported symptoms in subjects newly diagnosed with NTM lung infection caused by MAC who have not started standard treatment.
This is an experimental clinical research study, and ALIS is an experimental drug. “Experimental” means that the study treatment is currently being tested in clinical research studies.
ALIS has not been approved for use in the treatment of patients with newly diagnosed NTM lung infection caused by MAC. However, ALIS was approved by the US Food and Drug Administration (FDA) for the treatment of MAC lung disease in adult patients who have received at least 6 months of treatment of multidrug therapy but who are not responsive and have limited or no other treatment options.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: lung infection,mycobaterium
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Age: Between 18 Years - 99 Years
-
Gender: All
Updated on
22 Aug 2024.
Study ID: 844692
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