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Study to Evaluate the Efficacy of Delpazolid as Add-on Therapy in Refractory Mycobacterium Abscessus Complex
Sponsor: LigaChem Biosciences, Inc.
Summary
The purpose of this study is to evaluate the efficacy and safety of delpazolid add-on therapy in Patients with Refractory Mycobacterium abscessus Complex Pulmonary disease
Official title: A Phase 2a, Open-label, Single-arm, Multi-center Study to Evaluate the Efficacy and Safety of LCB01-0371 (Delpazolid) as Add-on Therapy in Patients With Refractory Mycobacterium Abscessus Complex Pulmonary Disease
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2024-01-16
Completion Date
2026-12-30
Last Updated
2025-08-22
Healthy Volunteers
No
Interventions
Delpazolid
Three tablets (400 mg/tablet) of delpazolid will be orally administered once daily for 12 weeks. After 3 months (12 weeks) of administration, if the investigator determines that there are clinical benefits, an additional extended treatment of up to 9 months (40 weeks) may be given, amounting to 1 year of treatment in total.
Locations (5)
Asan Medical Center
Seoul, South Korea
Bundang Seoul National University Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Bundang Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea