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ACTIVE NOT RECRUITING
NCT06004037
PHASE2

Study to Evaluate the Efficacy of Delpazolid as Add-on Therapy in Refractory Mycobacterium Abscessus Complex

Sponsor: LigaChem Biosciences, Inc.

View on ClinicalTrials.gov

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

DRUG

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