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A Study of Bedaquiline Administered as Part of a Treatment Regimen With Clarithromycin and Ethambutol in Adult Patients With Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)
Sponsor: Janssen Pharmaceutical K.K.
Summary
The purpose of the study is to evaluate the efficacy of bedaquiline (BDQ) compared with rifamycin when administered as part of a treatment regimen with clarithromycin (CAM) and ethambutol (EB) in adult participants with treatment-refractory Mycobacterium avium complex-lung disease (MAC-LD) at Week 24 for microbiological assessment in mycobacteria growth indicator tube (MGIT).
Official title: A Phase 2/3, Multicenter, Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy and Safety of Bedaquiline Administered as Part of a Treatment Regimen With Clarithromycin and Ethambutol in Adult Patients With Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)
Key Details
Gender
All
Age Range
20 Years - 79 Years
Study Type
INTERVENTIONAL
Enrollment
129
Start Date
2021-01-08
Completion Date
2025-11-14
Last Updated
2026-04-15
Healthy Volunteers
No
Interventions
Bedaquiline
Participants will receive BDQ tablets only/
Clarithromycin
Participants will receive CAM 400 or 500 mg twice a day.
Ethambutol
Participants will receive 500 to 750 mg daily (maximum daily dose of 1.0 gram \[g\]) or 15 mg/kg once a day.
Rifampicin
Participants will receive daily dose is 450 mg (maximum 600 mg) RFP capsule once a day.
Rifabutin
Participants will receive daily dose of RBT 300 mg or 150 mg capsules once a day.
Locations (55)
Fukuoka University Chikushi Hospital
Chikushino-shi, Japan
St. Luke's International Hospital
Chūōku, Japan
Fukui Prefectural Hospital
Fukui-shi, Japan
National Hospital Organization Ibarakihigashi
Funaishikawa, Japan
Gifu Prefectural General Medical Center
Gifu, Japan
Hamamatsu Rosai Hospital
Hamamatsu, Japan
Seirei Hamamatsu General Hospital
Hamamatsu, Japan
National Hospital Organization Tenryu Hospital
Hamamatue, Japan
Matsunami General Hospital
Hashima-gun, Japan
Matsunami Health Promotion Clinic
Hashimagun Kasamatsucho, Japan
National Hospital Organization Himeji Medical Center
Himeji, Japan
Saitama Medical University Hospital
Iruma-gun, Japan
National Hospital Organization Minami Kyoto Hospital
Jōyō, Japan
Fukujuji Hospital
Kiyose, Japan
Kobe City Medical Center West Hospital
Kobe Nagata-Ku, Japan
National Hospital Organization Kochi National Hospital
Kochi, Japan
National Hospital Organization Fukuoka Higashi Medical Center
Koga, Japan
Saitama Prefectural Cardiovascular and Respiratory Center
Kumagaya, Japan
Rakuwakai Otowa Hospital
Kyoto, Japan
National Hospital Organization Kyoto Medical Center
Kyoto, Japan
Matsusaka Municipal Hospital
Matsusaka, Japan
Musashino Red Cross Hospital
Musashino, Japan
Nagaoka Red Cross Hospital
Nagaoka, Japan
Nagasaki University Hospital
Nagasaki, Japan
Kojunkai Daido Clinic
Nagoya, Japan
National Hospital Organization Nagoya Medical Center
Nagoya, Japan
National Hospital Organization Nishiniigata Chuo Hospital
Niigata, Japan
National Hospital Organization Omuta Hospital
Omuta, Japan
National Hospital Organization Sagamihara National Hospital
Sagamihara, Japan
Saitama City Hospital
Saitama-shi, Japan
Kinki-chuo Chest Medical Center
Sakai, Japan
Hokkaido Medical Center
Sapporo Nishi-Ku, Japan
Tohoku Medical And Pharmaceutical University Hospital
Sendai, Japan
National Hospital Organization Nara Medical Center
Shichijō, Japan
Tokyo Shinagawa Hospital
Shinagawa-ku, Japan
National Center for Global Health and Medicine
Shinjuku, Japan
Keio University Hospital
Shinjuku-ku, Japan
Nagano Prefectural Shinshu Medical Center
Suzaka, Japan
National Hospital Organization Tokyo Medical Center
Tokyo, Japan
National Hospital Organization Tokyo National Hospital
Tokyo, Japan
National Hospital Organization Osaka Toneyama Medical Center
Toyonaka-shi, Japan
Toyota Kosei Hospital
Toyota, Japan
Toyota Memorial Hospital
Toyota-shi, Japan
National Hospital Organization Ehime Medical Center
Tōon, Japan
JRC Wakayama Medical Center
Wakayama, Japan
Shimonoseki City Hospital
Yamaguchi, Japan
Kanagawa Cardiovascular And Respiratory Center
Yokohama, Japan
Chonnam National University Hospital
Gwangju, South Korea
The Catholic University of Korea, Incheon St. Mary's Hospital
Incheon, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan