search
Back to results

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)

Primary Purpose

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

Status
Recruiting
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Bedaquiline
Clarithromycin
Ethambutol
Rifampicin
Rifabutin
Sponsored by
Janssen Pharmaceutical K.K.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has body weight greater than or equal to (>=) 40 kilograms (kg) at screening and on Day 1
  • Has radiological evidence consistent with nontuberculous mycobacterial lung disease (NTM-LD) based on a chest Computed Tomography (CT) scan taken within 6 months prior to screening or at screening
  • Has at least 2 positive sputum cultures of Mycobacterium avium complex (MAC) (sputum cultures to be taken at least 4 weeks apart): one obtained within 12 months prior to screening, which was documented while being treated for Mycobacterium avium complex lung disease (MAC-LD) for a total of at least 6 months and no longer than 36 months; and one at screening (by central microbiology laboratory)
  • Received at least 6 months and no more than 36 months of consecutive MAC-LD treatment (at least 2 antibiotics for MAC, including a macrolide), that is either ongoing or has stopped within 12 months prior to screening
  • No presence of cognitive dysfunction that would impact the completion of the patient reported outcome (PRO) assessments

Exclusion Criteria:

  • Had previous exposure to bedaquiline (BDQ)
  • Has active Tuberculosis (TB) disease
  • Has cystic fibrosis, medically unstable respiratory disease (for example, chronic obstructive pulmonary disease, bronchiectasis, asthma)
  • Has one or more cavities >=2 centimeter (cm) in diameter on a chest CT scan taken within 6 months prior to screening or at screening
  • Treatment already includes an injectable/inhaled aminoglycoside within 3 months prior to screening or the investigator deems the participant to be a candidate for an aminoglycoside at screening

Sites / Locations

  • Toyota Memorial HospitalRecruiting
  • Fukuoka University Chikushi HospitalRecruiting
  • St. Luke's International HospitalRecruiting
  • Fukui Prefectural HospitalRecruiting
  • Gifu Prefectural General Medical Center
  • Hamamatsu Rosai HospitalRecruiting
  • Seirei Hamamatsu General HospitalRecruiting
  • NHO Tenryu HospitalRecruiting
  • Matsunami General HospitalRecruiting
  • Matsunami Health Promotion ClinicRecruiting
  • National Hospital Organization Himeji Medical CenterRecruiting
  • Saitama Medical University HospitalRecruiting
  • National Hospital Organization Minami Kyoto HospitalRecruiting
  • Fukujuji HospitalRecruiting
  • Kobe City Hospital Organization Kobe City Medical Center West Hospital
  • National Hospital Organization Kochi National HospitalRecruiting
  • National Hospital Organization Fukuoka Higashi Medical CenterRecruiting
  • Saitama Prefectural Cardiovascular and Respiratory CenterRecruiting
  • Rakuwakai Otowa Hospital
  • National Hospital Organization Kyoto Medical CenterRecruiting
  • Matsusaka Municipal HospitalRecruiting
  • Musashino Red Cross HospitalRecruiting
  • Nagaoka Red Cross HospitalRecruiting
  • Nagasaki University HospitalRecruiting
  • National Hospital Organization Nagoya Medical CenterRecruiting
  • Kojunkai Daido ClinicRecruiting
  • National Hospital Organization Nishiniigata Chuo HospitalRecruiting
  • National Hospital Organization Omuta National HospitalRecruiting
  • National Hospital Organization Sagamihara National HospitalRecruiting
  • Saitama City HospitalRecruiting
  • Kinki-chuo Chest Medical CenterRecruiting
  • Hokkaido Medical CenterRecruiting
  • Tohoku Medical And Pharmaceutical University HospitalRecruiting
  • National Hospital Organization Nara Medical CenterRecruiting
  • Tokyo Shinagawa HospitalRecruiting
  • Keio University HospitalRecruiting
  • Nagano Prefectural Shinshu Medical CenterRecruiting
  • National Hospital Organization IbarakihigashiRecruiting
  • National Hospital Organization Tokyo Medical CenterRecruiting
  • National Center for Global Health and MedicineRecruiting
  • National Hospital Organization Tokyo National HospitalRecruiting
  • National Hospital Organization Ehime Medical CenterRecruiting
  • National Hospital Organization Osaka Toneyama Medical CenterRecruiting
  • Toyota Kosei HospitalRecruiting
  • JRC Wakayama Medical Center
  • Shimonoseki City HospitalRecruiting
  • Kanagawa Cardiovascular And Respiratory CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A: Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)

Group B: Rifampicin (RFP) or Rifabutin (RBT) + CAM + EB

Arm Description

Participants will receive BDQ 400 milligrams (mg) (4*100 mg tablets) once daily (qd) from Week 1-2 (loading phase), BDQ 200 mg (2*100mg tablets) bi-weekly (biw) from Week 3 to 48 (maintenance phase) and CAM 400 mg or 500 mg twice daily (2*200 mg tablets) along with EB 500-750 mg or 15 mg/kg once a day or maximum daily dose of 1.0 gram for up to Week 48.

Participants will receive maximum of 4 capsules of RFP 450 mg daily (or maximum daily dose of 600 mg), CAM 400 mg or 500 mg (2*200 mg tablets) twice a day along with EB 500-750 mg daily or 15 mg/kg once a day or maximum daily dose of 1.0 gram for up to Week 48, followed by 2 capsules of RBT 300 mg or 150 mg once a day.

Outcomes

Primary Outcome Measures

Percentage of Participants with Sputum Culture Conversion in Mycobacteria Growth Indicator Tube (MGIT) at Week 24
Percentage of participant with sputum culture conversion (defined as 3 consecutive negative sputum cultures taken at least 25 days apart) in MGIT at Week 24 will be assessed.

Secondary Outcome Measures

Percentage of Participants with Sputum Culture Conversion in 7H10 or 7H11 agar media at Week 24
Percentage of participants with sputum culture conversion (defined as 3 consecutive negative sputum cultures taken at least 25 days apart) in 7H10 or 7H11 agar media at Week 24 will be assessed.
Change from Baseline in Patient-reported Health Status on Total Score of St. George's Respiratory Questionnaire (SGRQ) at Week 24
The SGRQ is a self-administered questionnaire that has been validated in participants with airways disease, specifically in participants with bronchiectasis. The SGRQ assesses health-related quality of life in participants with chronic pulmonary disease by evaluating 3 health domains: symptoms (distress caused by respiratory symptoms); activity (effects of disturbances on mobility and physical activity); and impacts (the effect of disease on factors such as employment, personal control of one's health, and need for medication). A composite total score is derived as the sum of domain scores for symptoms, activity, and impact (0 = best possible score and 100 = worst possible score).
Percentage of Participants with Sputum Culture Conversion in MGIT and 7H10 or 7H11 agar media at Week 48 and Week 60
Percentage of participants with sputum culture conversion (defined as 3 consecutive negative sputum cultures taken at least 25 days apart) in MGIT and 7H10 or 7H11 agar media at Week 48 and Week 60 will be assessed.
Percentage of Participants with Sputum Culture Negativity in MGIT and 7H10 or 7H11 at each visit after Week 2
Percentage of participants with sputum culture negativity in MGIT and 7H10 or 7H11 at each visit after Week 2 will be assessed.
Time to Sputum Culture Conversion in MGIT up to Week 48
Sputum culture conversion is defined as 3 consecutive negative sputum cultures taken at least 25 days apart. Percentage of participants with sputum culture in 7H10 or 7H11 agar media at Week 24 will be assessed. Time to sputum culture conversion in MGIT up to Week 48 will be assessed.
Time to Positivity in MGIT up to Week 48
Time to positivity in MGIT up to week 48 will be assessed.
Change From Baseline in Patient Reported Health Status on Total Score of SGRQ at Weeks 48 and 60
The SGRQ is a self-administered questionnaire that has been validated in participants with airways disease, specifically in participants with bronchiectasis. The SGRQ assesses health-related quality of life in participants with chronic pulmonary disease by evaluating 3 health domains: symptoms (distress caused by respiratory symptoms); activity (effects of disturbances on mobility and physical activity); and impacts (the effect of disease on factors such as employment, personal control of one's health, and need for medication). A composite total score is derived as the sum of domain scores for symptoms, activity, and impact (0 = best possible score and 100 = worst possible score). A within patient reduction from baseline in score of 4 units is generally recognized as a clinically meaningful improvement in quality of life.
Change From Baseline in Lung Function Parameters (Forced Vital Capacity) at Weeks 24, 48, and 60
The lung function parameters including forced expiration volume will be assessed.
Change From Baseline in Lung Function Parameters (Inspiratory Capacity) at Weeks 24, 48, and 60
The lung function parameters including Inspiratory Capacity will be assessed.
Change From Baseline in Lung Function Parameters (Functional Residual Capacity and Total Lung Capacity) at Weeks 24, 48, and 60
The lung function parameters including functional residual capacity and total lung capacity will be assessed.
Percentage of Participants who Undergo a Change in Their Mycobacterium Avium Complex-lung Disease (MAC-LD) Treatment Regimen by Week 24 and by Week 48 in Group A and by Week 60 in Group B
Percentage of participants who undergo a change in their MAC-LD treatment regimen will be assessed.
Number of Participants with Adverse Events (AE)
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
Number of Participants with Clinical Laboratory Abnormalities
Number of participants with clinical laboratory abnormalities (Hematology, Clinical chemistry, and Urinalysis) will be assessed.
Number of Participants with 12-Lead Electrocardiogram (ECG) Abnormalities
Number of participants with 12-Lead ECG Abnormalities will be assessed.
Number of Participants with Vital Signs Abnormalities
Number of participants with vital signs abnormalities (body temperature [axillary], heart rate, respiratory rate, oxygen saturation, blood pressure [systolic and diastolic]) will be assessed.
Number of Participants with Physical Examination Abnormalities
Number of Participants with physical examination abnormalities (all body systems [including height and body weight measurement] and observation for skin events/reactions) will be assessed.
Number of Participants with Visual Examination Abnormalities
Number of participants with visual examination abnormalities (visual acuity testing, color discrimination, visual field testing, and fundoscopy and audiology) will be assessed.
Maximum Plasma Concentration (Cmax) of Bedaquiline and its Metabolite M2
Cmax is defined as maximum observed analyte concentration.
Minimum Plasma Concentration Between 0 Hour and the Dosing Interval (tau) (Ctrough) of Bedaquiline and its Metabolite M2
Ctrough is the minimum plasma concentration between 0 hour and dosing interval (tau).
Area Under the Plasma Concentration-time Curve From Time Zero to End of Dosing Interval (tau) (AUC [0-tau]) of Bedaquiline and its Metabolite M2
AUC (0-tau) is area under the plasma concentration-time curve from time zero to end of dosing interval (tau).
Cmax of Clarithromycin and its Metabolite 4-OH CAM
Cmax is defined as maximum observed analyte concentration.
C (0-trough) of Clarithromycin and its Metabolite 4-OH CAM
Ctrough is the minimum plasma concentration between 0 hour and dosing interval (tau).
AUC (0-tau) of Clarithromycin and its Metabolite 4-OH CAM
AUC (0-tau) is area under the plasma concentration-time curve from time zero to end of dosing interval (tau).

Full Information

First Posted
November 12, 2020
Last Updated
October 10, 2023
Sponsor
Janssen Pharmaceutical K.K.
search

1. Study Identification

Unique Protocol Identification Number
NCT04630145
Brief Title
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)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 8, 2021 (Actual)
Primary Completion Date
September 23, 2025 (Anticipated)
Study Completion Date
February 10, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Pharmaceutical K.K.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)
Arm Type
Experimental
Arm Description
Participants will receive BDQ 400 milligrams (mg) (4*100 mg tablets) once daily (qd) from Week 1-2 (loading phase), BDQ 200 mg (2*100mg tablets) bi-weekly (biw) from Week 3 to 48 (maintenance phase) and CAM 400 mg or 500 mg twice daily (2*200 mg tablets) along with EB 500-750 mg or 15 mg/kg once a day or maximum daily dose of 1.0 gram for up to Week 48.
Arm Title
Group B: Rifampicin (RFP) or Rifabutin (RBT) + CAM + EB
Arm Type
Active Comparator
Arm Description
Participants will receive maximum of 4 capsules of RFP 450 mg daily (or maximum daily dose of 600 mg), CAM 400 mg or 500 mg (2*200 mg tablets) twice a day along with EB 500-750 mg daily or 15 mg/kg once a day or maximum daily dose of 1.0 gram for up to Week 48, followed by 2 capsules of RBT 300 mg or 150 mg once a day.
Intervention Type
Drug
Intervention Name(s)
Bedaquiline
Intervention Description
Participants will receive BDQ tablets only/
Intervention Type
Drug
Intervention Name(s)
Clarithromycin
Intervention Description
Participants will receive CAM 400 or 500 mg twice a day.
Intervention Type
Drug
Intervention Name(s)
Ethambutol
Intervention Description
Participants will receive 500 to 750 mg daily (maximum daily dose of 1.0 gram [g]) or 15 mg/kg once a day.
Intervention Type
Drug
Intervention Name(s)
Rifampicin
Intervention Description
Participants will receive daily dose is 450 mg (maximum 600 mg) RFP capsule once a day.
Intervention Type
Drug
Intervention Name(s)
Rifabutin
Intervention Description
Participants will receive daily dose of RBT 300 mg or 150 mg capsules once a day.
Primary Outcome Measure Information:
Title
Percentage of Participants with Sputum Culture Conversion in Mycobacteria Growth Indicator Tube (MGIT) at Week 24
Description
Percentage of participant with sputum culture conversion (defined as 3 consecutive negative sputum cultures taken at least 25 days apart) in MGIT at Week 24 will be assessed.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants with Sputum Culture Conversion in 7H10 or 7H11 agar media at Week 24
Description
Percentage of participants with sputum culture conversion (defined as 3 consecutive negative sputum cultures taken at least 25 days apart) in 7H10 or 7H11 agar media at Week 24 will be assessed.
Time Frame
Up to Week 24
Title
Change from Baseline in Patient-reported Health Status on Total Score of St. George's Respiratory Questionnaire (SGRQ) at Week 24
Description
The SGRQ is a self-administered questionnaire that has been validated in participants with airways disease, specifically in participants with bronchiectasis. The SGRQ assesses health-related quality of life in participants with chronic pulmonary disease by evaluating 3 health domains: symptoms (distress caused by respiratory symptoms); activity (effects of disturbances on mobility and physical activity); and impacts (the effect of disease on factors such as employment, personal control of one's health, and need for medication). A composite total score is derived as the sum of domain scores for symptoms, activity, and impact (0 = best possible score and 100 = worst possible score).
Time Frame
Baseline and Week 24
Title
Percentage of Participants with Sputum Culture Conversion in MGIT and 7H10 or 7H11 agar media at Week 48 and Week 60
Description
Percentage of participants with sputum culture conversion (defined as 3 consecutive negative sputum cultures taken at least 25 days apart) in MGIT and 7H10 or 7H11 agar media at Week 48 and Week 60 will be assessed.
Time Frame
Up to Week 48 and Week 60
Title
Percentage of Participants with Sputum Culture Negativity in MGIT and 7H10 or 7H11 at each visit after Week 2
Description
Percentage of participants with sputum culture negativity in MGIT and 7H10 or 7H11 at each visit after Week 2 will be assessed.
Time Frame
From Week 2 to Week 60
Title
Time to Sputum Culture Conversion in MGIT up to Week 48
Description
Sputum culture conversion is defined as 3 consecutive negative sputum cultures taken at least 25 days apart. Percentage of participants with sputum culture in 7H10 or 7H11 agar media at Week 24 will be assessed. Time to sputum culture conversion in MGIT up to Week 48 will be assessed.
Time Frame
Up to Week 48
Title
Time to Positivity in MGIT up to Week 48
Description
Time to positivity in MGIT up to week 48 will be assessed.
Time Frame
Up to Week 48
Title
Change From Baseline in Patient Reported Health Status on Total Score of SGRQ at Weeks 48 and 60
Description
The SGRQ is a self-administered questionnaire that has been validated in participants with airways disease, specifically in participants with bronchiectasis. The SGRQ assesses health-related quality of life in participants with chronic pulmonary disease by evaluating 3 health domains: symptoms (distress caused by respiratory symptoms); activity (effects of disturbances on mobility and physical activity); and impacts (the effect of disease on factors such as employment, personal control of one's health, and need for medication). A composite total score is derived as the sum of domain scores for symptoms, activity, and impact (0 = best possible score and 100 = worst possible score). A within patient reduction from baseline in score of 4 units is generally recognized as a clinically meaningful improvement in quality of life.
Time Frame
From baseline to Week 48 and Week 60
Title
Change From Baseline in Lung Function Parameters (Forced Vital Capacity) at Weeks 24, 48, and 60
Description
The lung function parameters including forced expiration volume will be assessed.
Time Frame
At Weeks 24, 48, and 60
Title
Change From Baseline in Lung Function Parameters (Inspiratory Capacity) at Weeks 24, 48, and 60
Description
The lung function parameters including Inspiratory Capacity will be assessed.
Time Frame
At Weeks 24, 48, and 60
Title
Change From Baseline in Lung Function Parameters (Functional Residual Capacity and Total Lung Capacity) at Weeks 24, 48, and 60
Description
The lung function parameters including functional residual capacity and total lung capacity will be assessed.
Time Frame
At Weeks 24, 48, and 60
Title
Percentage of Participants who Undergo a Change in Their Mycobacterium Avium Complex-lung Disease (MAC-LD) Treatment Regimen by Week 24 and by Week 48 in Group A and by Week 60 in Group B
Description
Percentage of participants who undergo a change in their MAC-LD treatment regimen will be assessed.
Time Frame
Week 24 and Week 48 (Group A) and by week 60 (Group B)
Title
Number of Participants with Adverse Events (AE)
Description
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
Time Frame
Up to Week 60
Title
Number of Participants with Clinical Laboratory Abnormalities
Description
Number of participants with clinical laboratory abnormalities (Hematology, Clinical chemistry, and Urinalysis) will be assessed.
Time Frame
Up to Week 60
Title
Number of Participants with 12-Lead Electrocardiogram (ECG) Abnormalities
Description
Number of participants with 12-Lead ECG Abnormalities will be assessed.
Time Frame
Up to Week 60
Title
Number of Participants with Vital Signs Abnormalities
Description
Number of participants with vital signs abnormalities (body temperature [axillary], heart rate, respiratory rate, oxygen saturation, blood pressure [systolic and diastolic]) will be assessed.
Time Frame
Up to Week 60
Title
Number of Participants with Physical Examination Abnormalities
Description
Number of Participants with physical examination abnormalities (all body systems [including height and body weight measurement] and observation for skin events/reactions) will be assessed.
Time Frame
Up to Week 60
Title
Number of Participants with Visual Examination Abnormalities
Description
Number of participants with visual examination abnormalities (visual acuity testing, color discrimination, visual field testing, and fundoscopy and audiology) will be assessed.
Time Frame
Up to Week 60
Title
Maximum Plasma Concentration (Cmax) of Bedaquiline and its Metabolite M2
Description
Cmax is defined as maximum observed analyte concentration.
Time Frame
Day 1, Weeks 2, 8, 12, 24 and Week 48
Title
Minimum Plasma Concentration Between 0 Hour and the Dosing Interval (tau) (Ctrough) of Bedaquiline and its Metabolite M2
Description
Ctrough is the minimum plasma concentration between 0 hour and dosing interval (tau).
Time Frame
Day 1, Weeks 2, 8, 12, 24 and Week 48
Title
Area Under the Plasma Concentration-time Curve From Time Zero to End of Dosing Interval (tau) (AUC [0-tau]) of Bedaquiline and its Metabolite M2
Description
AUC (0-tau) is area under the plasma concentration-time curve from time zero to end of dosing interval (tau).
Time Frame
Day 1, Weeks 2, 8, 12, 24 and Week 48
Title
Cmax of Clarithromycin and its Metabolite 4-OH CAM
Description
Cmax is defined as maximum observed analyte concentration.
Time Frame
Day 1, Weeks 2, 8, 12 and 24
Title
C (0-trough) of Clarithromycin and its Metabolite 4-OH CAM
Description
Ctrough is the minimum plasma concentration between 0 hour and dosing interval (tau).
Time Frame
Day 1, Weeks 2, 8, 12 and 24
Title
AUC (0-tau) of Clarithromycin and its Metabolite 4-OH CAM
Description
AUC (0-tau) is area under the plasma concentration-time curve from time zero to end of dosing interval (tau).
Time Frame
Day 1, Weeks 2, 8, 12 and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has body weight greater than or equal to (>=) 40 kilograms (kg) at screening and on Day 1 Has radiological evidence consistent with nontuberculous mycobacterial lung disease (NTM-LD) based on a chest Computed Tomography (CT) scan taken within 6 months prior to screening or at screening Has at least 2 positive sputum cultures of Mycobacterium avium complex (MAC) (sputum cultures to be taken at least 4 weeks apart): one obtained within 12 months prior to screening, which was documented while being treated for Mycobacterium avium complex lung disease (MAC-LD) for a total of at least 6 months; and one at screening (by central microbiology laboratory) Received at least 6 months of consecutive MAC-LD treatment (at least 2 antibiotics for MAC, including a macrolide), that is either ongoing or has stopped within 12 months prior to screening No presence of cognitive dysfunction that would impact the completion of the patient reported outcome (PRO) assessments Exclusion Criteria: Had previous exposure to bedaquiline (BDQ) Has active Tuberculosis (TB) disease Has cystic fibrosis, medically unstable respiratory disease (for example, chronic obstructive pulmonary disease, bronchiectasis, asthma) Has one or more cavities >=2 centimeter (cm) in diameter on a chest CT scan taken within 6 months prior to screening or at screening Treatment already includes an injectable/inhaled aminoglycoside within 3 months prior to screening or the investigator deems the participant to be a candidate for an injectable/inhaled aminoglycoside during screening period or at Day 1
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Pharmaceutical K.K., Japan clinical Trials
Organizational Affiliation
Janssen Pharmaceutical K.K.
Official's Role
Study Director
Facility Information:
Facility Name
Toyota Memorial Hospital
City
Aichi
ZIP/Postal Code
471-8513
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fukuoka University Chikushi Hospital
City
Chikushino-shi
ZIP/Postal Code
818-8502
Country
Japan
Individual Site Status
Recruiting
Facility Name
St. Luke's International Hospital
City
Chuo-ku
ZIP/Postal Code
104-8560
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fukui Prefectural Hospital
City
Fukui-shi
ZIP/Postal Code
910-0846
Country
Japan
Individual Site Status
Recruiting
Facility Name
Gifu Prefectural General Medical Center
City
Gifu
ZIP/Postal Code
500-8717
Country
Japan
Individual Site Status
Completed
Facility Name
Hamamatsu Rosai Hospital
City
Hamamatsu-shi
ZIP/Postal Code
430-8525
Country
Japan
Individual Site Status
Recruiting
Facility Name
Seirei Hamamatsu General Hospital
City
Hamamatsu
ZIP/Postal Code
430-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
NHO Tenryu Hospital
City
Hamamatue
ZIP/Postal Code
434-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Matsunami General Hospital
City
Hashima-gun
ZIP/Postal Code
501-6062
Country
Japan
Individual Site Status
Recruiting
Facility Name
Matsunami Health Promotion Clinic
City
Hashimagun Kasamatsucho
ZIP/Postal Code
501-6062
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Himeji Medical Center
City
Himeji
ZIP/Postal Code
670-8520
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saitama Medical University Hospital
City
Iruma-gun
ZIP/Postal Code
350-0495
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Minami Kyoto Hospital
City
Joyo
ZIP/Postal Code
610-0113
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fukujuji Hospital
City
Kiyose
ZIP/Postal Code
204-0022
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kobe City Hospital Organization Kobe City Medical Center West Hospital
City
Kobe Nagata-Ku
ZIP/Postal Code
653-0013
Country
Japan
Individual Site Status
Completed
Facility Name
National Hospital Organization Kochi National Hospital
City
Kochi
ZIP/Postal Code
780-8077
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Fukuoka Higashi Medical Center
City
Koga
ZIP/Postal Code
811-3195
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saitama Prefectural Cardiovascular and Respiratory Center
City
Kumagaya
ZIP/Postal Code
360-0197
Country
Japan
Individual Site Status
Recruiting
Facility Name
Rakuwakai Otowa Hospital
City
Kyoto
ZIP/Postal Code
607-8062
Country
Japan
Individual Site Status
Completed
Facility Name
National Hospital Organization Kyoto Medical Center
City
Kyoto
ZIP/Postal Code
612-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Matsusaka Municipal Hospital
City
Matsusaka
ZIP/Postal Code
515-8544
Country
Japan
Individual Site Status
Recruiting
Facility Name
Musashino Red Cross Hospital
City
Musashino
ZIP/Postal Code
180-8610
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagaoka Red Cross Hospital
City
Nagaoka
ZIP/Postal Code
940-2085
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagasaki University Hospital
City
Nagasaki-shi
ZIP/Postal Code
852-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Nagoya Medical Center
City
Nagoya-shi
ZIP/Postal Code
460-0001
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kojunkai Daido Clinic
City
Nagoya
ZIP/Postal Code
457-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Nishiniigata Chuo Hospital
City
Niigata
ZIP/Postal Code
950-2085
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Omuta National Hospital
City
Omuta
ZIP/Postal Code
837-0911
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Sagamihara National Hospital
City
Sagamihara
ZIP/Postal Code
252-0392
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saitama City Hospital
City
Saitama-shi
ZIP/Postal Code
336-8522
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kinki-chuo Chest Medical Center
City
Sakai
ZIP/Postal Code
591-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hokkaido Medical Center
City
Sapporo Nishi-Ku
ZIP/Postal Code
063-0005
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tohoku Medical And Pharmaceutical University Hospital
City
Sendai
ZIP/Postal Code
983-8512
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Nara Medical Center
City
Shichijo, Nara-city
ZIP/Postal Code
630-8053
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Shinagawa Hospital
City
Shinagawa-ku
ZIP/Postal Code
140-8522
Country
Japan
Individual Site Status
Recruiting
Facility Name
Keio University Hospital
City
Shinjuku-ku
ZIP/Postal Code
160-8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagano Prefectural Shinshu Medical Center
City
Suzaka
ZIP/Postal Code
386-8610
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Ibarakihigashi
City
Tokai-mura
ZIP/Postal Code
319-1113
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Tokyo Medical Center
City
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Center for Global Health and Medicine
City
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Tokyo National Hospital
City
Tokyo
ZIP/Postal Code
204-8585
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Ehime Medical Center
City
Toon
ZIP/Postal Code
791-0281
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Osaka Toneyama Medical Center
City
Toyonaka-shi
ZIP/Postal Code
560-8552
Country
Japan
Individual Site Status
Recruiting
Facility Name
Toyota Kosei Hospital
City
Toyota
ZIP/Postal Code
470-0396
Country
Japan
Individual Site Status
Recruiting
Facility Name
JRC Wakayama Medical Center
City
Wakayama
ZIP/Postal Code
640-8558
Country
Japan
Individual Site Status
Completed
Facility Name
Shimonoseki City Hospital
City
Yamaguchi
ZIP/Postal Code
750-0041
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kanagawa Cardiovascular And Respiratory Center
City
Yokohama
ZIP/Postal Code
236-0051
Country
Japan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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)

We'll reach out to this number within 24 hrs