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)

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

129

Participants

Timeline

Start Date

January 8, 2021

Primary Completion Date

February 18, 2025

Study Completion Date

December 2, 2025

Conditions
Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)
Interventions
DRUG

Bedaquiline

Participants will receive BDQ tablets only/

DRUG

Clarithromycin

Participants will receive CAM 400 or 500 mg twice a day.

DRUG

Ethambutol

Participants will receive 500 to 750 mg daily (maximum daily dose of 1.0 gram \[g\]) or 15 mg/kg once a day.

DRUG

Rifampicin

Participants will receive daily dose is 450 mg (maximum 600 mg) RFP capsule once a day.

DRUG

Rifabutin

Participants will receive daily dose of RBT 300 mg or 150 mg capsules once a day.

Trial Locations (55)

112

Taipei Veterans General Hospital, Taipei

10002

National Taiwan University Hospital, Taipei

40705

Taichung Veterans General Hospital, Taichung

61469

Chonnam National University Hospital, Gwangju

80756

Kaohsiung Medical University Chung Ho Memorial Hospital, Kaohsiung City

818-8502

Fukuoka University Chikushi Hospital, Chikushino-shi

104 8560

St. Luke's International Hospital, Chūōku

910-0846

Fukui Prefectural Hospital, Fukui-shi

319-1113

National Hospital Organization Ibarakihigashi, Funaishikawa

500-8717

Gifu Prefectural General Medical Center, Gifu

430-8525

Hamamatsu Rosai Hospital, Hamamatsu

430-8558

Seirei Hamamatsu General Hospital, Hamamatsu

434-8511

National Hospital Organization Tenryu Hospital, Hamamatue

501-6062

Matsunami General Hospital, Hashima-gun

Matsunami Health Promotion Clinic, Hashimagun Kasamatsucho

670-8520

National Hospital Organization Himeji Medical Center, Himeji

350-0495

Saitama Medical University Hospital, Iruma-gun

610-0113

National Hospital Organization Minami Kyoto Hospital, Jōyō

204-0022

Fukujuji Hospital, Kiyose

653-0013

Kobe City Medical Center West Hospital, Kobe Nagata-Ku

780-8077

National Hospital Organization Kochi National Hospital, Kochi

811-3195

National Hospital Organization Fukuoka Higashi Medical Center, Koga

360-0197

Saitama Prefectural Cardiovascular and Respiratory Center, Kumagaya

607-8062

Rakuwakai Otowa Hospital, Kyoto

612-8555

National Hospital Organization Kyoto Medical Center, Kyoto

515-8544

Matsusaka Municipal Hospital, Matsusaka

180-8610

Musashino Red Cross Hospital, Musashino

940-2085

Nagaoka Red Cross Hospital, Nagaoka

852-8501

Nagasaki University Hospital, Nagasaki

457-8511

Kojunkai Daido Clinic, Nagoya

460-0001

National Hospital Organization Nagoya Medical Center, Nagoya

950-2085

National Hospital Organization Nishiniigata Chuo Hospital, Niigata

837-0911

National Hospital Organization Omuta Hospital, Omuta

252-0392

National Hospital Organization Sagamihara National Hospital, Sagamihara

336-8522

Saitama City Hospital, Saitama-shi

591-8555

Kinki-chuo Chest Medical Center, Sakai

063-0005

Hokkaido Medical Center, Sapporo Nishi-Ku

983-8512

Tohoku Medical And Pharmaceutical University Hospital, Sendai

630-8053

National Hospital Organization Nara Medical Center, Shichijō

140-8522

Tokyo Shinagawa Hospital, Shinagawa-ku

162-8655

National Center for Global Health and Medicine, Shinjuku

160-8582

Keio University Hospital, Shinjuku-ku

386-8610

Nagano Prefectural Shinshu Medical Center, Suzaka

152-8902

National Hospital Organization Tokyo Medical Center, Tokyo

204-8585

National Hospital Organization Tokyo National Hospital, Tokyo

560-8552

National Hospital Organization Osaka Toneyama Medical Center, Toyonaka-shi

470-0396

Toyota Kosei Hospital, Toyota

471-8513

Toyota Memorial Hospital, Toyota-shi

791-0281

National Hospital Organization Ehime Medical Center, Tōon

640 8558

JRC Wakayama Medical Center, Wakayama

750-0041

Shimonoseki City Hospital, Yamaguchi

236-0051

Kanagawa Cardiovascular And Respiratory Center, Yokohama

403-720

The Catholic University of Korea, Incheon St. Mary's Hospital, Incheon

05505

Asan Medical Center, Seoul

135-230

Samsung Medical Center, Seoul

Sponsors
All Listed Sponsors
lead

Janssen Pharmaceutical K.K.

INDUSTRY

NCT04630145 - 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) | Biotech Hunter | Biotech Hunter