Global Alliance for TB Drug Development 
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21 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
TBI-223 / Global Alliance for TB Drug Development
RAD-TB, NCT06192160: Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis

Suspended
2
315
RoW
Isoniazid, INH, Rifampicin, RIF, Pyrazinamide, PZA, Ethambutol, EMB, Bedaquiline, BDQ, Pretomanid, Pa, Linezolid, LZD, TBI-223, Sutezolid, SZD
National Institute of Allergy and Infectious Diseases (NIAID), TB Alliance
Pulmonary Tuberculosis
03/26
03/27
pretomanid (PA-824) / Global Alliance for TB Drug Development
ZeNix, NCT03086486: Various Doses and Durations of Linezolid Plus Bedaquiline & Pretomanid in Participants With Drug Resistant Tuberculosis

Completed
3
181
RoW
Pretomanid, PA-824, Pa, Linezolid, L, Lin, Zyvox, Bedaquiline, TMC-207, B, Sirturo, Placebo Linezolid
Global Alliance for TB Drug Development
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR, Tuberculosis, Extensively Drug-Resistant Tuberculosis, Pre-XDR-TB, XDR-TB
02/21
02/22
NCT05040126: Modified BPaL Regimen for Managing Pre-XDR TB and MDR (TI/NR) TB in India

Active, not recruiting
3
400
RoW
Linezolid, Bedaquiline, Pretomanid
Tuberculosis Research Centre, India, International Union Against Tuberculosis and Lung Diseases, Sarvodaya Charitable Trust Hospital, Ghatkopar, Mumbai, Shatabdi Centenary Hospital, Govandi, Mumbai, King George's Medical College and Hospital, Lucknow, SN Medical College, Agra, Govt Medical College & Hospital, Bhavnagar, Govt. Medical College & Hospital, Surat, National Institute for Tuberculosis and Respiratory Diseases, New Delhi, Rajan Babu Institute of Pulmonary Medicine and Tuberculosis, Delhi, Govt.Rajaji Medical college and hospital, Madurai
Pre-Extensively Drug-Resistant Pulmonary TB, Treatment Intolerant Multidrug-Resistant Pulmonary TB, Non-responsive Multidrug-Resistant Pulmonary TB
12/24
12/24
NCT06905522: A PAN-USR TB Multi-Center Trial

Not yet recruiting
3
610
NA
Bedaquiline (B), Sitafloxacin (S), Linezolid (L), Pyrazinamide (Z), Isoniazid (H), Rifampicin (R), Ethambutol (E), Moxifloxacin (M), Pretomanid (Pa)
Shenzhen Third People's Hospital, First Affiliated Hospital of Zhejiang University, Beijing Chest Hospital of Capital Medical University, Shenyang Tenth People's Hospital, The Sixth People's Hospital of the Xinjiang Uygur Autonomous Region, The Fourth Hospital of Inner Mongolia Autonomous Region, Guizhou Aerospace Hospital
Pulmonary Tuberculosis
01/29
12/29
PRACTECAL-EE, NCT04207112: Economic Evaluation of New MDR TB Regimens

Completed
2/3
73
RoW
Bedaquiline, Sirturo, R207910, TMC207, Pretomanid, PA-824, Moxifloxacin, Avelox, BAY 12-8039, Linezolid, Zyvox, Clofazimine, Lamprene, Standard Drugs
Medecins Sans Frontieres, Netherlands, London School of Hygiene and Tropical Medicine, Ministry of Health, Republic of Uzbekistan, Ministry of Public Health, Republic of Belarus, THINK TB & HIV Investigative Network, University of Liverpool, Wits Health Consortium (Pty) Ltd
Multi-drug Resistant Tuberculosis, Extensively Drug-Resistant Tuberculosis, Pulmonary Tuberculoses
08/22
08/22
TB-PRACTECAL, NCT02589782: Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s)

Completed
2/3
552
RoW
Bedaquiline, Sirturo, R207910, TMC207, Pretomanid, PA-824, Moxifloxacin, Avelox, Linezolid, Zyvox, Clofazimine, Lamprene, Locally accepted standard of care which is consistent with the WHO recommendations for the treatment of M/XDR-TB.
Medecins Sans Frontieres, Netherlands, London School of Hygiene and Tropical Medicine, Global Alliance for TB Drug Development, University College, London, Drugs for Neglected Diseases, Swiss Tropical & Public Health Institute, eResearch Technology, Inc., Ministry of Health, Republic of Uzbekistan, World Health Organization, Ministry of Public Health, Republic of Belarus, THINK TB & HIV Investigative Network, University of Liverpool, Wits Health Consortium (Pty) Ltd, Rutgers, The State University of New Jersey, University of California, San Francisco
Tuberculosis, Multidrug-Resistant, Extensively Drug-Resistant Tuberculosis, Tuberculosis, Pulmonary
08/22
08/22
PRACTECAL-PKPD, NCT04081077: Sub Study

Active, not recruiting
2/3
240
RoW
Bedaquiline, Sirturo, R207910, TMC207, Pretomanid, PA-824, Moxifloxacin, Avelox, BAY 12-8039, Linezolid, Zyvox, Clofazimine, Lamprene
Medecins Sans Frontieres, Netherlands, London School of Hygiene and Tropical Medicine, Global Alliance for TB Drug Development, University College, London, Drugs for Neglected Diseases, Swiss Tropical & Public Health Institute, eResearch Technology, Inc., Ministry of Health, Republic of Uzbekistan, World Health Organization, Ministry of Public Health, Republic of Belarus, THINK TB & HIV Investigative Network, University of Liverpool, Wits Health Consortium (Pty) Ltd, Hackensack Meridian Health, University of California, San Francisco, Minsk Republican Research and Practical Centre for Pulmonology and Tuberculosis
Multi-drug Resistant Tuberculosis, Extensively Drug-Resistant Tuberculosis, Pulmonary Tuberculosis
09/22
09/22
PRACTECAL-PRO, NCT03942354: Patient-reported Experiences and Quality of Life Outcomes in the TB-PRACTECAL Clinical Trial

Completed
2/3
137
RoW
Bedaquiline, Sirturo, R207910, TMC207, Pretomanid, PA-824, Moxifloxacin, Avelox, BAY 12-8039, Linezolid, Zyvox, Clofazimine, Lamprene, Directly observed therapy (DOT)
Medecins Sans Frontieres, Netherlands, University of Sussex, London School of Hygiene and Tropical Medicine, THINK TB & HIV Investigative Network, Wits Health Consortium (Pty) Ltd, Ministry of Public Health, Republic of Belarus, Ministry of Health, Republic of Uzbekistan
Multidrug Resistant Tuberculosis
05/22
05/22
PRISM-TB, NCT06441006: Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis

Not yet recruiting
2/3
400
RoW
Bedaquiline, Sirturo, Linezolid, Zyvox, Pretomanid, Pretamyl, Moxifloxacin, Avelox, Control Arm FQ-S MDR/RR-TB regimen, designed according to latest international guidelines
University of California, San Francisco, Johns Hopkins University
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR
08/31
08/31
panTB-HM, NCT05686356: A Pan-TB Regimen Targeting Host and Microbe

Active, not recruiting
2/3
352
RoW
Sutezolid, N-acetyl cysteine, NAC, Pretomanid, Bedaquiline, Rifafour
The Aurum Institute NPC, Ludwig-Maximilians - University of Munich, Stichting Katholieke Universiteit, Wits Health Consortium (Pty) Ltd, Instituto Nacional de Saúde, Mozambique, National Institute for Medical Research, Tanzania, University of Stellenbosch, Sequella, Inc., Global Alliance for TB Drug Development
Tuberculosis
01/26
01/26
PaSEM, NCT04179500: A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis

Completed
2
26
RoW
Pretomanid, Pa-824, Doprevla, Pa, Bedaquiline, Sirturo, B, moxifloxacin, Avelox, M, pyrazinamide, Pyzina, Tebrazid, Z
Global Alliance for TB Drug Development
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR, Tuberculosis, Drug-Resistant Tuberculosis
06/23
07/24
NCT06058299: Phase 2 Trial Assessing TBAJ876 or Bedaquiline, with Pretomanid and Linezolid in Adults with Drug-sensitive Pulmonary Tuberculosis

Active, not recruiting
2
309
RoW
TBAJ-876, Pretomanid, PA-824, Dovprela, Linezolid, Zyvox, Bedaquiline, Sirturo, TMC207, HRZE, HR
Global Alliance for TB Drug Development
Pulmonary TB, Pulmonary Tuberculosis, Drug Sensitive Tuberculosis
12/24
06/26
PARADIGM4TB, NCT06114628: Platform Assessing Regimens and Durations In a Global Multisite Consortium for TB

Recruiting
2
2500
RoW
GSK3036656, BTZ-043, Bedaquiline (B), Delamanid (D), Pretomanid (Pa), Moxifloxacin (M), Linezolid (L), Pyrazinamide (Z), Rifampicin (R), Isoniazid (H), Ethambutol (E)
University College, London, Radboud University Medical Center, London School of Hygiene and Tropical Medicine, University of Oxford, Research Center Borstel, Lygature, TASK Applied Science, Vita-Salute San Raffaele University, Helmholtz Zentrum Munchen, KNCV Tuberculosis Foundation, Critical Path Institute, European Lung Foundation, Instituto de Saude Publica da Universidade do Porto, University of Liverpool, Institut de Recherche Pour le Developpment, University of Hamburg-Eppendorf, University of California, San Francisco, TB Alliance, Find, University of Milano, University of St Andrews, Uppsala University, European Respiratory Society, Tuberculosis Network European Trialsgroup, Janssen, LP, Otsuka Pharmaceutical Development & Commercialization, Inc., German Center for Infection Research, LMU University Hospital Munich, University of Cambridge, GlaxoSmithKline
Pulmonary Tuberculosis
02/27
08/27
NCT05971602: Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis

Terminated
2
93
RoW
Delamanid, Bedaquiline, OPC-167832, and Sutezolid (DBOS), Pretomanid, Bedaquiline, OPC-167832, and Sutezolid (PBOS), Isoniazid, Rifampicin, Pyrazinamide, Ethambutol (HRZE), Pretomanid or Delamanid, Bedaquiline, OPC-167832, and Sutezolid (XBOS), Isoniazid and Rifampicin (HR)
Bill & Melinda Gates Medical Research Institute, Global Alliance for TB Drug Development, Janssen Pharmaceuticals, Otsuka Pharmaceutical Co., Ltd.
Pulmonary Tuberculosis
02/25
02/25
A Single Center, Randomized, Open Study on Pharmacokinetic Characteristics and Food Effect ( PA-824-1X02 ), ChiCTR2200066301: Phase I Clinical Study to Evaluate the Pharmacokinetics, Safety, Tolerance and Food Effect of Pretomanid (PA-824) Tablets in Chinese Healthy Subjects

Recruiting
1
16
 
8 subjects in group 1 take a single dose of 200mg under fasted state on Day1 and 200mg after a high-fat meal on Day10; 8 subjects in group 2 take a single dose of 200mg after a high-fat meal on Day1 and 200mg under fasted state on Day10
Peking University Third Hospital; Shenyang Hongqi Pharmaceutical Co., Ltd, Own funds
Tuberculosis
 
 
NCT03896750: Single-Dose Study to Evaluate the PKs of Pretomanid in Participants With Renal Impairment Compared to Participants With Normal Renal Function

Completed
1
12
US
PA-824
National Institute of Allergy and Infectious Diseases (NIAID)
Renal Impairment, Tuberculosis
08/24
10/24
NCT02422524: Pretomanid in Adults With Hepatic Impairment

Terminated
1
14
US
PA-824
National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis
08/23
11/23
NCT05586230: Study of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children With Rifampicin-Resistant Tuberculosis

Recruiting
1
72
RoW
Pretomanid, Pa, Optimized background regimen (OBR) for multidrug-resistant TB (MDR-TB)
National Institute of Allergy and Infectious Diseases (NIAID), Global Alliance for TB Drug Development, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
Tuberculosis, Rifampicin Resistant Tuberculosis
01/26
01/26
NCT05609552: Biodistribution and Pharmacokinetics of Pretomanid in Tuberculosis Patients Using 18F-Pretomanid PET

Recruiting
N/A
20
US
18F-Pretomanid PET/CT
Johns Hopkins University, National Heart, Lung, and Blood Institute (NHLBI)
Tuberculosis
02/26
02/27
bedaquiline analogue (TBAJ-587) / Global Alliance for TB Drug Development
NCT04890535: Evaluation of the Safety, Tolerability, PK of TBAJ-587 in Healthy Adults

Completed
1
106
Europe
TBAJ-587, Placebo
Global Alliance for TB Drug Development, QPS Holdings LLC
Tuberculosis
02/23
02/23
TBAJ-876 / Global Alliance for TB Drug Development
NCT05526911: A Phase 1, Drug-Drug Interaction Study of TBAJ-876 in Healthy Adults

Completed
1
28
US
TBAJ-876, Midazolam, Digoxin
Global Alliance for TB Drug Development
Pulmonary Disease, Tuberculosis, Pulmonary, Tuberculosis, Multi Drug Resistant Tuberculosis, Drug Sensitive Tuberculosis, Drug-resistant Tuberculosis, Mycobacterium Tuberculosis Infection
09/22
09/22
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
TBI-223 / Global Alliance for TB Drug Development
RAD-TB, NCT06192160: Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis

Suspended
2
315
RoW
Isoniazid, INH, Rifampicin, RIF, Pyrazinamide, PZA, Ethambutol, EMB, Bedaquiline, BDQ, Pretomanid, Pa, Linezolid, LZD, TBI-223, Sutezolid, SZD
National Institute of Allergy and Infectious Diseases (NIAID), TB Alliance
Pulmonary Tuberculosis
03/26
03/27
pretomanid (PA-824) / Global Alliance for TB Drug Development
ZeNix, NCT03086486: Various Doses and Durations of Linezolid Plus Bedaquiline & Pretomanid in Participants With Drug Resistant Tuberculosis

Completed
3
181
RoW
Pretomanid, PA-824, Pa, Linezolid, L, Lin, Zyvox, Bedaquiline, TMC-207, B, Sirturo, Placebo Linezolid
Global Alliance for TB Drug Development
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR, Tuberculosis, Extensively Drug-Resistant Tuberculosis, Pre-XDR-TB, XDR-TB
02/21
02/22
NCT05040126: Modified BPaL Regimen for Managing Pre-XDR TB and MDR (TI/NR) TB in India

Active, not recruiting
3
400
RoW
Linezolid, Bedaquiline, Pretomanid
Tuberculosis Research Centre, India, International Union Against Tuberculosis and Lung Diseases, Sarvodaya Charitable Trust Hospital, Ghatkopar, Mumbai, Shatabdi Centenary Hospital, Govandi, Mumbai, King George's Medical College and Hospital, Lucknow, SN Medical College, Agra, Govt Medical College & Hospital, Bhavnagar, Govt. Medical College & Hospital, Surat, National Institute for Tuberculosis and Respiratory Diseases, New Delhi, Rajan Babu Institute of Pulmonary Medicine and Tuberculosis, Delhi, Govt.Rajaji Medical college and hospital, Madurai
Pre-Extensively Drug-Resistant Pulmonary TB, Treatment Intolerant Multidrug-Resistant Pulmonary TB, Non-responsive Multidrug-Resistant Pulmonary TB
12/24
12/24
NCT06905522: A PAN-USR TB Multi-Center Trial

Not yet recruiting
3
610
NA
Bedaquiline (B), Sitafloxacin (S), Linezolid (L), Pyrazinamide (Z), Isoniazid (H), Rifampicin (R), Ethambutol (E), Moxifloxacin (M), Pretomanid (Pa)
Shenzhen Third People's Hospital, First Affiliated Hospital of Zhejiang University, Beijing Chest Hospital of Capital Medical University, Shenyang Tenth People's Hospital, The Sixth People's Hospital of the Xinjiang Uygur Autonomous Region, The Fourth Hospital of Inner Mongolia Autonomous Region, Guizhou Aerospace Hospital
Pulmonary Tuberculosis
01/29
12/29
PRACTECAL-EE, NCT04207112: Economic Evaluation of New MDR TB Regimens

Completed
2/3
73
RoW
Bedaquiline, Sirturo, R207910, TMC207, Pretomanid, PA-824, Moxifloxacin, Avelox, BAY 12-8039, Linezolid, Zyvox, Clofazimine, Lamprene, Standard Drugs
Medecins Sans Frontieres, Netherlands, London School of Hygiene and Tropical Medicine, Ministry of Health, Republic of Uzbekistan, Ministry of Public Health, Republic of Belarus, THINK TB & HIV Investigative Network, University of Liverpool, Wits Health Consortium (Pty) Ltd
Multi-drug Resistant Tuberculosis, Extensively Drug-Resistant Tuberculosis, Pulmonary Tuberculoses
08/22
08/22
TB-PRACTECAL, NCT02589782: Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s)

Completed
2/3
552
RoW
Bedaquiline, Sirturo, R207910, TMC207, Pretomanid, PA-824, Moxifloxacin, Avelox, Linezolid, Zyvox, Clofazimine, Lamprene, Locally accepted standard of care which is consistent with the WHO recommendations for the treatment of M/XDR-TB.
Medecins Sans Frontieres, Netherlands, London School of Hygiene and Tropical Medicine, Global Alliance for TB Drug Development, University College, London, Drugs for Neglected Diseases, Swiss Tropical & Public Health Institute, eResearch Technology, Inc., Ministry of Health, Republic of Uzbekistan, World Health Organization, Ministry of Public Health, Republic of Belarus, THINK TB & HIV Investigative Network, University of Liverpool, Wits Health Consortium (Pty) Ltd, Rutgers, The State University of New Jersey, University of California, San Francisco
Tuberculosis, Multidrug-Resistant, Extensively Drug-Resistant Tuberculosis, Tuberculosis, Pulmonary
08/22
08/22
PRACTECAL-PKPD, NCT04081077: Sub Study

Active, not recruiting
2/3
240
RoW
Bedaquiline, Sirturo, R207910, TMC207, Pretomanid, PA-824, Moxifloxacin, Avelox, BAY 12-8039, Linezolid, Zyvox, Clofazimine, Lamprene
Medecins Sans Frontieres, Netherlands, London School of Hygiene and Tropical Medicine, Global Alliance for TB Drug Development, University College, London, Drugs for Neglected Diseases, Swiss Tropical & Public Health Institute, eResearch Technology, Inc., Ministry of Health, Republic of Uzbekistan, World Health Organization, Ministry of Public Health, Republic of Belarus, THINK TB & HIV Investigative Network, University of Liverpool, Wits Health Consortium (Pty) Ltd, Hackensack Meridian Health, University of California, San Francisco, Minsk Republican Research and Practical Centre for Pulmonology and Tuberculosis
Multi-drug Resistant Tuberculosis, Extensively Drug-Resistant Tuberculosis, Pulmonary Tuberculosis
09/22
09/22
PRACTECAL-PRO, NCT03942354: Patient-reported Experiences and Quality of Life Outcomes in the TB-PRACTECAL Clinical Trial

Completed
2/3
137
RoW
Bedaquiline, Sirturo, R207910, TMC207, Pretomanid, PA-824, Moxifloxacin, Avelox, BAY 12-8039, Linezolid, Zyvox, Clofazimine, Lamprene, Directly observed therapy (DOT)
Medecins Sans Frontieres, Netherlands, University of Sussex, London School of Hygiene and Tropical Medicine, THINK TB & HIV Investigative Network, Wits Health Consortium (Pty) Ltd, Ministry of Public Health, Republic of Belarus, Ministry of Health, Republic of Uzbekistan
Multidrug Resistant Tuberculosis
05/22
05/22
PRISM-TB, NCT06441006: Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis

Not yet recruiting
2/3
400
RoW
Bedaquiline, Sirturo, Linezolid, Zyvox, Pretomanid, Pretamyl, Moxifloxacin, Avelox, Control Arm FQ-S MDR/RR-TB regimen, designed according to latest international guidelines
University of California, San Francisco, Johns Hopkins University
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR
08/31
08/31
panTB-HM, NCT05686356: A Pan-TB Regimen Targeting Host and Microbe

Active, not recruiting
2/3
352
RoW
Sutezolid, N-acetyl cysteine, NAC, Pretomanid, Bedaquiline, Rifafour
The Aurum Institute NPC, Ludwig-Maximilians - University of Munich, Stichting Katholieke Universiteit, Wits Health Consortium (Pty) Ltd, Instituto Nacional de Saúde, Mozambique, National Institute for Medical Research, Tanzania, University of Stellenbosch, Sequella, Inc., Global Alliance for TB Drug Development
Tuberculosis
01/26
01/26
PaSEM, NCT04179500: A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis

Completed
2
26
RoW
Pretomanid, Pa-824, Doprevla, Pa, Bedaquiline, Sirturo, B, moxifloxacin, Avelox, M, pyrazinamide, Pyzina, Tebrazid, Z
Global Alliance for TB Drug Development
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR, Tuberculosis, Drug-Resistant Tuberculosis
06/23
07/24
NCT06058299: Phase 2 Trial Assessing TBAJ876 or Bedaquiline, with Pretomanid and Linezolid in Adults with Drug-sensitive Pulmonary Tuberculosis

Active, not recruiting
2
309
RoW
TBAJ-876, Pretomanid, PA-824, Dovprela, Linezolid, Zyvox, Bedaquiline, Sirturo, TMC207, HRZE, HR
Global Alliance for TB Drug Development
Pulmonary TB, Pulmonary Tuberculosis, Drug Sensitive Tuberculosis
12/24
06/26
PARADIGM4TB, NCT06114628: Platform Assessing Regimens and Durations In a Global Multisite Consortium for TB

Recruiting
2
2500
RoW
GSK3036656, BTZ-043, Bedaquiline (B), Delamanid (D), Pretomanid (Pa), Moxifloxacin (M), Linezolid (L), Pyrazinamide (Z), Rifampicin (R), Isoniazid (H), Ethambutol (E)
University College, London, Radboud University Medical Center, London School of Hygiene and Tropical Medicine, University of Oxford, Research Center Borstel, Lygature, TASK Applied Science, Vita-Salute San Raffaele University, Helmholtz Zentrum Munchen, KNCV Tuberculosis Foundation, Critical Path Institute, European Lung Foundation, Instituto de Saude Publica da Universidade do Porto, University of Liverpool, Institut de Recherche Pour le Developpment, University of Hamburg-Eppendorf, University of California, San Francisco, TB Alliance, Find, University of Milano, University of St Andrews, Uppsala University, European Respiratory Society, Tuberculosis Network European Trialsgroup, Janssen, LP, Otsuka Pharmaceutical Development & Commercialization, Inc., German Center for Infection Research, LMU University Hospital Munich, University of Cambridge, GlaxoSmithKline
Pulmonary Tuberculosis
02/27
08/27
NCT05971602: Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis

Terminated
2
93
RoW
Delamanid, Bedaquiline, OPC-167832, and Sutezolid (DBOS), Pretomanid, Bedaquiline, OPC-167832, and Sutezolid (PBOS), Isoniazid, Rifampicin, Pyrazinamide, Ethambutol (HRZE), Pretomanid or Delamanid, Bedaquiline, OPC-167832, and Sutezolid (XBOS), Isoniazid and Rifampicin (HR)
Bill & Melinda Gates Medical Research Institute, Global Alliance for TB Drug Development, Janssen Pharmaceuticals, Otsuka Pharmaceutical Co., Ltd.
Pulmonary Tuberculosis
02/25
02/25
A Single Center, Randomized, Open Study on Pharmacokinetic Characteristics and Food Effect ( PA-824-1X02 ), ChiCTR2200066301: Phase I Clinical Study to Evaluate the Pharmacokinetics, Safety, Tolerance and Food Effect of Pretomanid (PA-824) Tablets in Chinese Healthy Subjects

Recruiting
1
16
 
8 subjects in group 1 take a single dose of 200mg under fasted state on Day1 and 200mg after a high-fat meal on Day10; 8 subjects in group 2 take a single dose of 200mg after a high-fat meal on Day1 and 200mg under fasted state on Day10
Peking University Third Hospital; Shenyang Hongqi Pharmaceutical Co., Ltd, Own funds
Tuberculosis
 
 
NCT03896750: Single-Dose Study to Evaluate the PKs of Pretomanid in Participants With Renal Impairment Compared to Participants With Normal Renal Function

Completed
1
12
US
PA-824
National Institute of Allergy and Infectious Diseases (NIAID)
Renal Impairment, Tuberculosis
08/24
10/24
NCT02422524: Pretomanid in Adults With Hepatic Impairment

Terminated
1
14
US
PA-824
National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis
08/23
11/23
NCT05586230: Study of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children With Rifampicin-Resistant Tuberculosis

Recruiting
1
72
RoW
Pretomanid, Pa, Optimized background regimen (OBR) for multidrug-resistant TB (MDR-TB)
National Institute of Allergy and Infectious Diseases (NIAID), Global Alliance for TB Drug Development, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
Tuberculosis, Rifampicin Resistant Tuberculosis
01/26
01/26
NCT05609552: Biodistribution and Pharmacokinetics of Pretomanid in Tuberculosis Patients Using 18F-Pretomanid PET

Recruiting
N/A
20
US
18F-Pretomanid PET/CT
Johns Hopkins University, National Heart, Lung, and Blood Institute (NHLBI)
Tuberculosis
02/26
02/27
bedaquiline analogue (TBAJ-587) / Global Alliance for TB Drug Development
NCT04890535: Evaluation of the Safety, Tolerability, PK of TBAJ-587 in Healthy Adults

Completed
1
106
Europe
TBAJ-587, Placebo
Global Alliance for TB Drug Development, QPS Holdings LLC
Tuberculosis
02/23
02/23
TBAJ-876 / Global Alliance for TB Drug Development
NCT05526911: A Phase 1, Drug-Drug Interaction Study of TBAJ-876 in Healthy Adults

Completed
1
28
US
TBAJ-876, Midazolam, Digoxin
Global Alliance for TB Drug Development
Pulmonary Disease, Tuberculosis, Pulmonary, Tuberculosis, Multi Drug Resistant Tuberculosis, Drug Sensitive Tuberculosis, Drug-resistant Tuberculosis, Mycobacterium Tuberculosis Infection
09/22
09/22

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