Lamprene (clofazimine) / Novartis 
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34 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Lamprene (clofazimine) / Novartis
ChiCTR1800014800: Multi-center, controlled clinical study of the safety, tolerability and efficacy of clofazimine in the treatment of drug-resistant tuberculosis

Completed
4
320
 
3Am(Cm) Lfx Cfz + Z E PAS(Pto) / 3Am(Cm) Lfx Cfz + Z E PAS(Pto) /18 Lfx Cfz + Z E PAS(Pto) ;3Am(Cm) Lfx+ Z E PAS(Pto) / 3Am(Cm) Lfx+ Z E PAS(Pto) /18 Lfx + Z E PAS(Pto) ;6Cm Mfx (Gfx) Cfz Z E PAS(Pto)+two 4-5 group drugs/3-6 Cm3 Mfx (Gfx) Cfz Z E PAS(Pto)+two 4-5 group drugs/21-24 Mfx (Gfx) Cfz Z E PAS(Pto)+two 4-5 group drugs ;6Cm Mfx (Gfx) Z E PAS(Pto)+two 4-5 group drugs/3-6 Cm3 Mfx (Gfx) Z E PAS(Pto)+two 4-5 group drugs/21-24 Mfx (Gfx) Z E PAS(Pto)+two 4-5 group drugs
Beijing Chest Hospital affiliated to Capital Medical University; Beijing Chest Hospital affiliated to Capital Medical University, Ministry of Science and Technology, China
Tuberculosis
 
 
ChiCTR1800020391: A randomized, multi-center, controlled trial for clofazimine-containing protocol in the treatment of newly diagnosed multidrug-resistant tuberculosis

Completed
4
144
 
6-8Cm Cfz CS Gfx Pto /6 Cfz CS GFX Pto ;6Cm Lfx CS Pto PZA/12 Lfx CS Pto PZA
Beijing Chest Hospital affiliated to Capital Medical University; Beijing Chest Hospital affiliated to Capital Medical University, Ministry of Science and Technology, China
Tuberculosis
 
 
PROSPECT, NCT05306223: A Study of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Participants With Multidrug-resistant Tuberculosis in China

Recruiting
4
212
RoW
Bedaquiline, SIRTURO, Levofloxacin, Linezolid, Cycloserine, Clofazimine, Pyrazinamide, Protionamide
Beijing Chest Hospital
Tuberculosis, Multidrug-Resistant
08/25
08/25
2015-003786-28: Research to assess effectiveness of treatment of pumonary infections with M.avium complex Onderzoek naar effectiviteit van behandeling van longinfecties met M.avium complex

Ongoing
3
123
Europe
Rifampicin, ethambutol, Azitromycine, RVG 116777//08702, RVG 117584//06445, RVG 28934, Capsule, Tablet, Lamprene, Rifadin, Myambutol, Azitromycine Teva
Radboudumc, Radboudumc
Fibrocavitary pulmonary disease caused by M.avium complex Fibrocavitaire pulmonale infectie met M.avium complex, Pulmonary infection with M.avium complex Longinfectie met M.avium complex, Diseases [C] - Respiratory Tract Diseases [C08]
 
 
STREAM, NCT02409290: The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB

Completed
3
588
RoW
Regimen A locally-used WHO-approved MDR-TB regimen (2011 guideline), Moxifloxacin, Avelox, Clofazimine, Lamprene, Ethambutol, Myambutol, Pyrazinamide, Zinamide, Isoniazid, Nydrazid, Isotamine, Prothionamide, Peteha, Kanamycin, Kantrex, Levofloxacin, Levaquin, Bedaquiline, SIRTURO
IUATLD, Inc, Medical Research Council, Institute of Tropical Medicine, Belgium, Liverpool School of Tropical Medicine, Rede TB
MDR-TB
05/22
05/23
endTB, NCT02754765: Evaluating Newly Approved Drugs for Multidrug-resistant TB

Completed
3
754
RoW
Bedaquiline, Sirturo, Delamanid, Deltyba, OPC-67683, Clofazimine, Lamprene, Levofloxacin, Moxifloxacin, Linezolid, Pyrazinamide, Control arm MDR-TB regimen, consistent with WHO guidelines
Médecins Sans Frontières, France, Partners in Health, Harvard Medical School (HMS and HSDM), Epicentre, Institute of Tropical Medicine, Belgium, Socios En Salud, Peru, Interactive Research and Development
Tuberculosis, Multidrug-Resistant, Infection, Bacterial, Pulmonary Tuberculoses
06/23
06/23
NCT04062201: Building Evidence for Advancing New Treatment for Rifampicin Resistant Tuberculosis (RR-TB) Comparing a Short Course of Treatment (Containing Bedaquiline, Delamanid and Linezolid) With the Current South African Standard of Care

Completed
3
402
RoW
Bedaquiline Oral Tablet, Sirturo, Linezolid Oral Tablet, Zyvox, Delamanid in Oral Dosage Form, Deltyba, Clofazimine Oral Product, Lamprene, Levofloxacin Oral Tablet, Isoniazid Oral Product, INH, Ethambutol Oral Product, Pyrazinamide Oral Product
Wits Health Consortium (Pty) Ltd, Regents of the University of California, University of Cape Town, Perinatal HIV Research Unit of the University of the Witswatersrand
Tuberculosis, Pre-XDR-TB, Extensively Drug-Resistant Tuberculosis, Multi Drug Resistant Tuberculosis, Rifampicin Resistant Tuberculosis
04/24
04/24
CleaR-MAC, NCT04616924: RHB-204 for the Treatment of Pulmonary Mycobacterium Avium Complex Disease

Active, not recruiting
3
125
US
RHB-204, Clarithromycin 158.3mg, Rifabutin 40mg and Clofazimine 13.3mg, Placebo
RedHill Biopharma Limited
Pulmonary Mycobacterium Avium Complex Infection, Bronchiectasis, Lung Diseases
12/23
12/24
2021-006613-10: A Phase 3, Multicenter, Open-label, Rater-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Bedaquiline for the Treatment of Multibacillary Leprosy When Combined With Rifampicin and Clofazimine

Not yet recruiting
3
386
RoW
Bedaquiline, Rifampicin, Clofazimine, Dapsone, Tablet, Capsule, Rifampicin Sandoz, Lamprene, Dapsone
Janssen Pharmaceutica NV, Janssen Pharmaceutica NV
Multibacillary Leprosy, Leprosy, Diseases [C] - Bacterial Infections and Mycoses [C01]
 
 
endTB-Q, NCT03896685: Evaluating Newly Approved Drugs in Combination Regimens for Multidrug-Resistant TB With Fluoroquinolone Resistance

Active, not recruiting
3
323
RoW
Bedaquiline 100 MG, TMC207, Delamanid 50 MG Oral Tablet, Clofazimine 100 MG Oral Capsule, Linezolid 600Mg Tab, Control arm MDR-TB regimen, designed according to latest WHO guidelines
Médecins Sans Frontières, France, Partners in Health, Harvard Medical School (HMS and HSDM), Epicentre, Institute of Tropical Medicine, Belgium, Socios En Salud, Peru, Interactive Research and Development, University of San Francisco
Tuberculosis, Multidrug-Resistant, Tuberculosis, Pulmonary Tuberculoses, Mycobacterial Infections, Bacterial Infections, Gram-Positive Bacterial Infections
09/24
11/24
ICoN-1, NCT06418711: Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation Suspension

Recruiting
3
234
US
Clofazimine Inhalation Suspension, MNKD-101, Placebo
Mannkind Corporation
MAC Lung Disease, Treatment Refractory MAC Lung Disease, Mycobacterium Infections, Nontuberculous
08/26
12/28
INSPIRE-BDLL, NCT06649721: Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BDLL Chinese Cohort

Not yet recruiting
3
120
RoW
bedaquiline, BDQ, B, delamanid, DLM, D, linezolid, LZD, L, Levofloxacin, LFX, Clofazimine, CFZ, C
Huashan Hospital, Beijing Chest Hospital
Drug-resistant Tuberculosis, Pulmonary Tuberculosis, Rifampin-resistant Tuberculosis
06/27
06/27
INSPIRE-CODA, NCT06081361: Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contezolid, Delamanid and Bedaquiline Cohort

Recruiting
3
186
RoW
Bedaquiline, BDQ, Delamanid, DLM, Contezolid, CZD, Levofloxacin, LFX, Moxifloxacin, MFX, Clofazimine, CFZ, Linezolid, LZD, Cycloserine, CS, Prothionamide, Pto, Pyrazinamide, PZA, Para-Aminosalicylic Acid, PAS, Ethambutol, EMB
Beijing Chest Hospital, National Medical Center for Infectious Diseases
Pulmonary Tuberculosis, Rifampicin-resistant Tuberculosis
10/26
12/26
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
FORMaT, NCT04310930: Finding the Optimal Regimen for Mycobacterium Abscessus Treatment

Recruiting
2/3
300
Europe, RoW
Amikacin, Tigecycline, Imipenem, Cefoxitin, Azithromycin, Clarithromycin, Clofazimine, Ethambutol, Linezolid, co-trimoxazole, Doxycycline, Moxifloxacin, Bedaquiline, Rifabutin
The University of Queensland, Australian Government Department of Health and Ageing, Children's Hospital Foundation, Cystic Fibrosis Foundation, Newcastle University, Griffith University, Erasmus Medical Center, Monash University, University of Copenhagen, Hôpital Cochin, South Australian Health and Medical Research Institute, University of Melbourne, James Cook University, Queensland, Australia, Murdoch Childrens Research Institute
Pulmonary Disease Due to Mycobacteria (Diagnosis)
06/29
06/30
NCT04465695: Dual Therapy With Interferon Beta-1b and Clofazimine for COVID-19

Recruiting
2
81
RoW
Interferon beta-1b, Clofazimine
The University of Hong Kong
COVID-19
06/21
09/21
2021-002062-40: Blood concentrations of clofazimine after a higher starting dose ('loading dose') in adult patients with infections caused by nontuberculous mycobacteria

Ongoing
2
10
Europe
Capsule, Lamprene
Radboud university medical center, Radboud university medical center
Nontuberculous mycobacterial disease, Infection caused by nontuberculous mycobaceria, Diseases [C] - Bacterial Infections and Mycoses [C01]
 
 
2020-000050-10: Finding the best treatment for lung disease from infection with Mycobacterium abscessus.

Not yet recruiting
2
300
Europe
Amikacin, Tigecycline, Imipenem and Cilastatin, Cefoxitin, Azithromycin, Clofazimine, Ethambutol, Clarithromycin, Linezolid, Trimethoprim and Sulfamethoxazole, Doxycycline, Moxifloxacin, Bedaquiline, Rifabutin, Solution for injection, Powder for solution for infusion, Film-coated tablet, Powder for oral suspension, Capsule, Tablet, Capsule, hard, Clofazimine "Lamprene", Trimethoprim and Sulfamethoxazole "SAD"
University of Queensland, Medical Research Futures Fund, Cystic Fibrosis Foundation, Anonymous Donor, Thoracic Society of Australia and New Zealand, The University of Queensland, Children's Hospital Foundation
Mycobacterium abscessus pulmonary disease, Nontuberculous mycobacterium (NTM) are a group of bacteria. These bacteria can cause significant lung damage in both healthy people and those with underlying lung disease., Diseases [C] - Respiratory Tract Diseases [C08]
 
 
C-LOAD, NCT05294146: Pharmacokinetic Study With a Loading Dose of Clofazimine in Adult Patients With Nontuberculous Mycobacterial Disease

Completed
2
12
Europe
Clofazimine, Lamprene
Radboud University Medical Center
Nontuberculous Mycobacterial Diseases
05/23
08/23
NCT04311502: Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST Study

Completed
2
104
RoW
Clofazimine (CFZ), Rifapentine (RPT), Isoniazid (INH), Pyrazinamide (PZA), Ethambutol (EMB), Rifampicin (RIF), Pyridoxine (vitamin B6)
National Institute of Allergy and Infectious Diseases (NIAID)
HIV, Tuberculosis
06/24
06/24
NCT02968212: Clofazimine in the Treatment of Pulmonary Mycobacterium Avium Complex (MAC)

Active, not recruiting
2
102
US
Clofazimine, Lamprene, sugar pill, placebo
Oregon Health and Science University, National Heart, Lung, and Blood Institute (NHLBI), National Jewish Health, The University of Texas Health Science Center at Tyler, National Institute of Allergy and Infectious Diseases (NIAID), University of Chicago, Temple University, University of South Florida
Mycobacterium Avium Complex
05/25
05/25
NCT05007821: Linezolid Dosing Strategies in Drug-Resistant TB

Active, not recruiting
2
138
RoW
Linezolid 600 mg, LZD, Linezolid 1200 mg (QD), Linezolid 1200 mg (TIW), Bedaquiline 200 mg, BDQ, Bedaquiline 100 mg, Delamanid 300 mg, DLM, Clofazimine 300 mg, CFZ, Clofazimine 100 mg
National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, Multidrug-Resistant, Tuberculosis, Tuberculosis, Pulmonary
03/25
03/26
PRESCIENT, NCT05556746: Ultra-Short Course Bedaquiline, Clofazimine, Pyrazinamide and Delamanid Versus Standard Therapy for Drug-Susceptible TB

Recruiting
2
156
RoW
Bedaquiline, Clofazimine, Pyrazinamide, Delamanid, Rifampin, Isoniazid, Ethambutol
Brigham and Women's Hospital, University of Cape Town, Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic, University of Stellenbosch, University of California, Los Angeles, Harvard School of Public Health (HSPH)
Tuberculosis, Pulmonary, HIV
06/25
01/27
DRAMATIC, NCT03828201: Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine to Treat MDR-TB

Recruiting
2
220
RoW
Delamanid, Deltyba, Levofloxacin, Levaquin, Bedaquiline, Sirturo, Clofazimine, Lamprene, Linezolid, Zyvox
Boston University, Novartis Pharmaceuticals, Pfizer, Otsuka Pharmaceutical Co., Ltd., University of California, San Francisco, Westat, National Institute of Allergy and Infectious Diseases (NIAID), University of Colorado, Denver, Harvard Medical School (HMS and HSDM), National Lung Hospital, Vietnam, De La Salle Health Sciences Institute, Philippines
Tuberculosis, Multidrug-Resistant
05/27
05/27
ACTRN12621001702808p: A Study of Clofazimine Inhalation Suspension (MNKD-101) in Healthy Volunteers

Not yet recruiting
1
40
 
MannKind Corporation, MannKind Corporation
Pulmonary Nontuberculous Mycobacteria Infections
 
 
ACTRN12621001702808: A Study of Clofazimine Inhalation Suspension (MNKD-101) in Healthy Volunteers

Completed
1
40
 
MannKind Corporation, MannKind Corporation
Pulmonary Nontuberculous Mycobacteria Infections
 
 
NCT04334070: Lamprene Multiple Patient Program

Available
N/A
NA
Lamprene®/Clofazimine
Novartis Pharmaceuticals
Non-Tuberculous Mycobacterial (NTM) Infections
 
 
TB-TRUSTplus, NCT04717908: Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T)-PLUS

Completed
N/A
89
RoW
Bedaquiline, BDQ, Pyrazinamide, PZA, Linezolid, LZD, Cycloserine, Cs, Clofazimine, CFZ
Huashan Hospital
Multidrug Resistant Tuberculosis
06/24
06/24
NCT00018044: Study of Mycobacterial Infections

Recruiting
N/A
1000
US
Clofazimine
National Institute of Allergy and Infectious Diseases (NIAID), Children's National Health System, University of Miami
Mycobacterium Infections
 
 
ChiCTR2100054533: Treatment Responses of Regimen Containing Clofazimine for M.avium complex Pulmonary Diseases

Not yet recruiting
N/A
48
 
Drug sensitivity test of Clofazimine and Macrolide
Beijing Chest Hospital; Beijing Chest Hospital, Beijing financial funds for science and technology
MAC Pulmonary Disease
 
 
NCT03625739: Population Pharmacokinetics of Anti-tuberculosis Drugs in Children With Tuberculosis

Recruiting
N/A
800
RoW
anti-tuberculosis drug, Isoniazid, Rifampicin, Pyrazinamide, Ethambutol, Levofloxacin, Moxifloxacin, Gatifloxacin, Amikacin, Capreomycin, Kanamycin (Streptomycin), Ethionamide, Cycloserine, terizidone, Clofazimine, Bedaquiline, Delamanid, p-aminosalicylic acid, Imipenem-cilastatind, Amoxicillin-clavulanate, Thioacetazone
Beijing Children's Hospital, Shandong University, Hopital Universitaire Robert-Debre, Rennes University Hospital
Tuberculosis
10/26
12/26

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