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A Phase 2 to Evaluate the Efficacy, Safety and Tolerability of Combinations of Bedaquiline, Moxifloxacin, PA-824 and Pyrazinamide in Adult Subjects With Drug-Sensitive or Multi Drug-Resistant Pulmonary Tuberculosis. (NC-005)

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ClinicalTrials.gov Identifier: NCT02193776
Recruitment Status : Completed
First Posted : July 18, 2014
Results First Posted : July 26, 2019
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Global Alliance for TB Drug Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Tuberculosis
Interventions Drug: PA-824
Drug: bedaquiline
Drug: moxifloxacin
Drug: pyrazinamide
Drug: isoniazid, rifampicin, pyrazinamide and ethambutol combination tablet
Enrollment 240
Recruitment Details This trial was conducted at 10 centers in 3 countries (South Africa, Tanzania, and Uganda) from 23 October 2014. Adult male and female participants with drug-sensitive (DS) or multi-drug resistant (MDR) smear-positive pulmonary tuberculosis (TB) were recruited into this open-label multi-center study.
Pre-assignment Details Participants were confirmed positive for M.tuberculosis on molecular test. DS-TB participants were to be sensitive to rifampicin and newly diagnosed with pulmonary TB (or untreated for at least 3 years). MDR-TB participants were to be resistant to rifampicin, sensitive to moxifloxacin and newly diagnosed with pulmonary TB (or treated for <=7 days).
Arm/Group Title DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide DS-TB: HRZE (Isoniazid+Rifampicin+Pyrazinamide+Ethambutol) MDR-TB: Bedaquiline (200 mg)+Moxifloxacin+PA-824+Pyrazinamide
Hide Arm/Group Description Participants with DS-TB were randomized to receive 400 milligrams (mg) bedaquiline once daily on Days 1 to 14, 200 mg three times a week (t.i.w) during Days 15 to 56 + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26. Participants with DS-TB were randomized to receive 200 mg bedaquiline + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26. Participants with DS-TB were randomized to receive combination tablets containing 75 mg isoniazid + 150 mg rifampicin + 400 mg pyrazinamide + 275 mg ethambutol orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8) with the daily dose per the participant's weight as follows: 30 to 37 kilograms (kg): 2 tablets; 38 to 54 kg: 3 tablets; 55 to 70 kg: 4 tablets; 71 kg and over: 5 tablets. Participants then entered a follow-up period up to Month 26. Participants with MDR-TB received 200 mg bedaquiline + 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.
Period Title: Overall Study
Started 59 60 61 60
Completed Day 70 Follow-up 54 56 60 60
Completed Day 140 Follow-up 52 52 58 58
Completed [1] 51 53 59 58
Not Completed 8 7 2 2
Reason Not Completed
Consent withdrawn             1             0             0             0
Failure to comply with protocol             0             1             0             0
Investigator/Sponsor decision             1             1             0             0
Death             1             0             0             0
Adverse event/Specific toxicity             5             5             2             2
[1]
Completed Treatment
Arm/Group Title DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide DS-TB: HRZE (Isoniazid+Rifampicin+Pyrazinamide+Ethambutol) MDR-TB: Bedaquiline (200 mg)+Moxifloxacin+PA-824+Pyrazinamide Total
Hide Arm/Group Description Participants with DS-TB were randomized to receive 400 mg bedaquiline once daily on Days 1 to 14, 200 mg t.i.w during Days 15 to 56 + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26. Participants with DS-TB were randomized to receive 200 mg bedaquiline + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26. Participants with DS-TB were randomized to receive combination tablets containing 75 mg isoniazid + 150 mg rifampicin + 400 mg pyrazinamide + 275 mg ethambutol orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8) with the daily dose per the participant's weight as follows: 30 to 37 kg: 2 tablets; 38 to 54 kg: 3 tablets; 55 to 70 kg: 4 tablets; 71 kg and over: 5 tablets. Participants then entered a follow-up period up to Month 26. Participants with MDR-TB received 200 mg bedaquiline + 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26. Total of all reporting groups
Overall Number of Baseline Participants 59 60 61 60 240
Hide Baseline Analysis Population Description
The safety analysis population included all participants who were randomized (for the DS participant population) or assigned (for the MDR participant population) to study drug and who received at least 1 administration of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants 60 participants 61 participants 60 participants 240 participants
35.1  (13.03) 33.9  (10.45) 33.3  (8.60) 34.0  (12.68) 34.1  (11.26)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 60 participants 61 participants 60 participants 240 participants
Female
14
  23.7%
12
  20.0%
15
  24.6%
17
  28.3%
58
  24.2%
Male
45
  76.3%
48
  80.0%
46
  75.4%
43
  71.7%
182
  75.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 60 participants 61 participants 60 participants 240 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.7%
1
   0.4%
Black or African American
46
  78.0%
49
  81.7%
49
  80.3%
53
  88.3%
197
  82.1%
White
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.7%
1
   0.4%
More than one race
13
  22.0%
11
  18.3%
12
  19.7%
5
   8.3%
41
  17.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Rate of Change in Time to Sputum Culture Positivity (TTP) Over 8 Weeks in the Mycobacterial Growth Indicator Tube (MGIT) System
Hide Description The bactericidal activity (BA) was determined by the rate of change in TTP collected from overnight sputum samples over 8 weeks of treatment in the liquid culture media MGIT system, represented by the model-fitted log(TTP) results as calculated by the regression of the observed log(TTP) results over time. The bactericidal activity of log(TTP) over Day 0 to Day 56 (BATTP[0-56]) was presented and expressed as the daily percentage change in TTP from Day 0 to Day 56. The mean BATTP (0-56) was calculated from Bayesian non-linear mixed effects regression models fitted to log(TTP) collected from sputum samples (observed from Day 0 to Day 56).
Time Frame Day 0 to Day 56 (8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intention-to-treat analysis population included all participants included in the safety analysis population for whom valid corresponding efficacy data were available. Pyrazinamide resistant participants were excluded from this analysis population (applicable to both participants with DS-TB and MDR-TB).
Arm/Group Title DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide DS-TB: HRZE (Isoniazid+Rifampicin+Pyrazinamide+Ethambutol) MDR-TB: Bedaquiline (200 mg)+Moxifloxacin+PA-824+Pyrazinamide
Hide Arm/Group Description:
Participants with DS-TB were randomized to receive 400 mg bedaquiline once daily on Days 1 to 14, 200 mg t.i.w during Days 15 to 56 + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.
Participants with DS-TB were randomized to receive 200 mg bedaquiline + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.
Participants with DS-TB were randomized to receive combination tablets containing 75 mg isoniazid + 150 mg rifampicin + 400 mg pyrazinamide + 275 mg ethambutol orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8) with the daily dose per the participant's weight as follows: 30 to 37 kg: 2 tablets; 38 to 54 kg: 3 tablets; 55 to 70 kg: 4 tablets; 71 kg and over: 5 tablets. Participants then entered a follow-up period up to Month 26.
Participants with MDR-TB received 200 mg bedaquiline + 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.
Overall Number of Participants Analyzed 57 56 59 37
Mean (Standard Deviation)
Unit of Measure: percentage change in TTP/day
4.878  (1.604) 5.182  (1.466) 4.046  (1.129) 5.194  (1.068)
2.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Hide Description A TEAE was defined as any AE which started or worsened on or after first study drug administration up to and including the Day 70 follow-up visit (or up to and including 14 days after last study drug administration for participants not having Day 70 follow-up visit). Drug-related TEAEs were defined as TEAEs for which relationship to study drug was indicated as 'possible', 'probable', 'certain' or missing. TEAEs leading to death were defined as TEAEs resulted 'fatal' outcome. Serious TEAEs were defined as TEAEs for which serious was indicated as 'yes'. TEAEs leading to discontinuation of study drug were defined as TEAEs for which action taken with study drug was indicated as 'study drug stopped'. TEAEs leading to early withdrawal from study were defined as TEAEs resulted study discontinuation. Grade III and IV TEAEs were defined as TEAEs for which severity (DMID grade) was indicated as 'Grade 3 (severe)' and 'Grade 4 (potentially life-threatening)' or missing, respectively.
Time Frame First study drug administration (Day 1) up to and including the Day 70 follow-up visit (or up to and including 14 days after last study drug administration for participants not having the Day 70 follow-up visit) (70 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population included all participants who were randomized (for the DS participant population) or assigned (for the MDR participant population) to study drug and received at least 1 administration of study drug.
Arm/Group Title DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide DS-TB: HRZE (Isoniazid+Rifampicin+Pyrazinamide+Ethambutol) MDR-TB: Bedaquiline (200 mg)+Moxifloxacin+PA-824+Pyrazinamide
Hide Arm/Group Description:
Participants with DS-TB were randomized to receive 400 mg bedaquiline once daily on Days 1 to 14, 200 mg t.i.w during Days 15 to 56 + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.
Participants with DS-TB were randomized to receive 200 mg bedaquiline + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.
Participants with DS-TB were randomized to receive combination tablets containing 75 mg isoniazid + 150 mg rifampicin + 400 mg pyrazinamide + 275 mg ethambutol orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8) with the daily dose per the participant's weight as follows: 30 to 37 kg: 2 tablets; 38 to 54 kg: 3 tablets; 55 to 70 kg: 4 tablets; 71 kg and over: 5 tablets. Participants then entered a follow-up period up to Month 26.
Participants with MDR-TB received 200 mg bedaquiline + 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.
Overall Number of Participants Analyzed 59 60 61 60
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
50
  84.7%
45
  75.0%
44
  72.1%
57
  95.0%
Drug-related TEAE
38
  64.4%
29
  48.3%
29
  47.5%
46
  76.7%
TEAE leading to death
1
   1.7%
1
   1.7%
1
   1.6%
0
   0.0%
Any serious TEAE
4
   6.8%
3
   5.0%
4
   6.6%
4
   6.7%
Drug-related serious TEAE
2
   3.4%
0
   0.0%
1
   1.6%
2
   3.3%
TEAE leading to discontinuation of study drug
6
  10.2%
5
   8.3%
2
   3.3%
2
   3.3%
TEAE leading to early withdrawal from study
5
   8.5%
5
   8.3%
2
   3.3%
2
   3.3%
Grade III TEAE
19
  32.2%
17
  28.3%
14
  23.0%
13
  21.7%
Grade IV TEAE
8
  13.6%
7
  11.7%
2
   3.3%
1
   1.7%
Time Frame TEAEs were collected from first study drug administration (Day 1) up to and including the Day 70 follow-up visit (or up to and including 14 days after last study drug administration for participants not having the Day 70 follow-up visit) (70 days).
Adverse Event Reporting Description The safety analysis population included all participants who were randomized (for the DS participant population) or assigned (for the MDR participant population) to study drug and received at least 1 administration of study drug. All-cause mortality is defined as death due to any cause for entire duration of study.
 
Arm/Group Title DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide DS-TB: HRZE (Isoniazid+Rifampicin+Pyrazinamide+Ethambutol) MDR-TB: Bedaquiline (200 mg)+Moxifloxacin+PA-824+Pyrazinamide
Hide Arm/Group Description Participants with DS-TB were randomized to receive 400 mg bedaquiline once daily on Days 1 to 14, 200 mg t.i.w during Days 15 to 56 + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26. Participants with DS-TB were randomized to receive 200 mg bedaquiline + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26. Participants with DS-TB were randomized to receive combination tablets containing 75 mg isoniazid + 150 mg rifampicin + 400 mg pyrazinamide + 275 mg ethambutol orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8) with the daily dose per the participant's weight as follows: 30 to 37 kg: 2 tablets; 38 to 54 kg: 3 tablets; 55 to 70 kg: 4 tablets; 71 kg and over: 5 tablets. Participants then entered a follow-up period up to Month 26. Participants with MDR-TB received 200 mg bedaquiline + 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.
All-Cause Mortality
DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide DS-TB: HRZE (Isoniazid+Rifampicin+Pyrazinamide+Ethambutol) MDR-TB: Bedaquiline (200 mg)+Moxifloxacin+PA-824+Pyrazinamide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/59 (3.39%)   3/60 (5.00%)   2/61 (3.28%)   4/60 (6.67%) 
Hide Serious Adverse Events
DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide DS-TB: HRZE (Isoniazid+Rifampicin+Pyrazinamide+Ethambutol) MDR-TB: Bedaquiline (200 mg)+Moxifloxacin+PA-824+Pyrazinamide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/59 (6.78%)   3/60 (5.00%)   4/61 (6.56%)   4/60 (6.67%) 
Blood and lymphatic system disorders         
Anaemia  1  0/59 (0.00%)  1/60 (1.67%)  0/61 (0.00%)  0/60 (0.00%) 
Cardiac disorders         
Pericardial effusion  1  0/59 (0.00%)  1/60 (1.67%)  0/61 (0.00%)  0/60 (0.00%) 
Hepatobiliary disorders         
Drug-induced liver injury  1  1/59 (1.69%)  0/60 (0.00%)  1/61 (1.64%)  0/60 (0.00%) 
Acute hepatic failure  1  0/59 (0.00%)  0/60 (0.00%)  1/61 (1.64%)  0/60 (0.00%) 
Infections and infestations         
Appendicitis  1  1/59 (1.69%)  0/60 (0.00%)  0/61 (0.00%)  0/60 (0.00%) 
Bronchopneumonia  1  0/59 (0.00%)  0/60 (0.00%)  0/61 (0.00%)  1/60 (1.67%) 
Gastroenteritis  1  0/59 (0.00%)  0/60 (0.00%)  1/61 (1.64%)  0/60 (0.00%) 
Malaria  1  0/59 (0.00%)  1/60 (1.67%)  0/61 (0.00%)  0/60 (0.00%) 
Pneumonia  1  0/59 (0.00%)  1/60 (1.67%)  0/61 (0.00%)  0/60 (0.00%) 
Pulmonary tuberculosis  1  0/59 (0.00%)  0/60 (0.00%)  1/61 (1.64%)  0/60 (0.00%) 
Investigations         
Alanine aminotransferase increased  1  1/59 (1.69%)  0/60 (0.00%)  0/61 (0.00%)  2/60 (3.33%) 
Aspartate aminotransferase increased  1  1/59 (1.69%)  0/60 (0.00%)  0/61 (0.00%)  2/60 (3.33%) 
Renal and urinary disorders         
Renal failure acute  1  0/59 (0.00%)  0/60 (0.00%)  1/61 (1.64%)  0/60 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Haemoptysis  1  0/59 (0.00%)  0/60 (0.00%)  1/61 (1.64%)  1/60 (1.67%) 
Pneumothorax  1  1/59 (1.69%)  0/60 (0.00%)  0/61 (0.00%)  0/60 (0.00%) 
Pneumothorax spontaneous  1  0/59 (0.00%)  1/60 (1.67%)  0/61 (0.00%)  0/60 (0.00%) 
Pulmonary artery aneurysm  1  0/59 (0.00%)  0/60 (0.00%)  0/61 (0.00%)  1/60 (1.67%) 
Pulmonary oedema  1  1/59 (1.69%)  0/60 (0.00%)  0/61 (0.00%)  0/60 (0.00%) 
1
Term from vocabulary, MedDRA (17.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide DS-TB: HRZE (Isoniazid+Rifampicin+Pyrazinamide+Ethambutol) MDR-TB: Bedaquiline (200 mg)+Moxifloxacin+PA-824+Pyrazinamide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   50/59 (84.75%)   45/60 (75.00%)   44/61 (72.13%)   57/60 (95.00%) 
Blood and lymphatic system disorders         
Anaemia  1  1/59 (1.69%)  4/60 (6.67%)  0/61 (0.00%)  1/60 (1.67%) 
Gastrointestinal disorders         
Vomiting  1  4/59 (6.78%)  1/60 (1.67%)  4/61 (6.56%)  7/60 (11.67%) 
Nausea  1  3/59 (5.08%)  1/60 (1.67%)  1/61 (1.64%)  5/60 (8.33%) 
Diarrhoea  1  3/59 (5.08%)  1/60 (1.67%)  0/61 (0.00%)  3/60 (5.00%) 
Infections and infestations         
Urinary tract infection  1  2/59 (3.39%)  0/60 (0.00%)  2/61 (3.28%)  4/60 (6.67%) 
Influenza  1  3/59 (5.08%)  0/60 (0.00%)  3/61 (4.92%)  0/60 (0.00%) 
Vulvovaginal candidiasis  1  0/59 (0.00%)  0/60 (0.00%)  0/61 (0.00%)  4/60 (6.67%) 
Investigations         
Blood uric acid increased  1  15/59 (25.42%)  13/60 (21.67%)  9/61 (14.75%)  27/60 (45.00%) 
Alanine aminotransferase increased  1  3/59 (5.08%)  5/60 (8.33%)  2/61 (3.28%)  2/60 (3.33%) 
Aspartate aminotransferase increased  1  3/59 (5.08%)  3/60 (5.00%)  3/61 (4.92%)  3/60 (5.00%) 
Amylase increased  1  0/59 (0.00%)  0/60 (0.00%)  1/61 (1.64%)  10/60 (16.67%) 
Gamma-glutamyltransferase increased  1  0/59 (0.00%)  2/60 (3.33%)  0/61 (0.00%)  6/60 (10.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  10/59 (16.95%)  5/60 (8.33%)  6/61 (9.84%)  13/60 (21.67%) 
Myalgia  1  5/59 (8.47%)  2/60 (3.33%)  1/61 (1.64%)  3/60 (5.00%) 
Pain in extremity  1  0/59 (0.00%)  2/60 (3.33%)  0/61 (0.00%)  4/60 (6.67%) 
Nervous system disorders         
Dizziness  1  3/59 (5.08%)  1/60 (1.67%)  3/61 (4.92%)  1/60 (1.67%) 
Renal and urinary disorders         
Haematuria  1  0/59 (0.00%)  0/60 (0.00%)  0/61 (0.00%)  4/60 (6.67%) 
Respiratory, thoracic and mediastinal disorders         
Haemoptysis  1  1/59 (1.69%)  3/60 (5.00%)  6/61 (9.84%)  6/60 (10.00%) 
Pleuritic pain  1  0/59 (0.00%)  0/60 (0.00%)  0/61 (0.00%)  6/60 (10.00%) 
Skin and subcutaneous tissue disorders         
Pruritus generalised  1  4/59 (6.78%)  4/60 (6.67%)  8/61 (13.11%)  2/60 (3.33%) 
Pruritus  1  3/59 (5.08%)  2/60 (3.33%)  3/61 (4.92%)  2/60 (3.33%) 
Rash  1  3/59 (5.08%)  0/60 (0.00%)  2/61 (3.28%)  1/60 (1.67%) 
1
Term from vocabulary, MedDRA (17.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Investigator or any Sub-Investigator shall submit any oral or written publication or abstract concerning this study to the Sponsor not less than thirty (30) days prior to submission to any journal, other publication or meeting for review and removal of confidential information.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Almari Conradie, Director, Clinical Operations
Organization: TB Alliance
Phone: +27 12 991 6328
EMail: almari.conradie@tballiance.org
Layout table for additonal information
Responsible Party: Global Alliance for TB Drug Development
ClinicalTrials.gov Identifier: NCT02193776    
Other Study ID Numbers: NC-005-(J-M-Pa-Z)
First Submitted: July 16, 2014
First Posted: July 18, 2014
Results First Submitted: February 22, 2019
Results First Posted: July 26, 2019
Last Update Posted: July 26, 2019