9 completed, 2 active not recruiting, 1 recruiting, 1 terminated. 14 Phase 3, 5 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 14 | Completed 9, Active not recruiting 2, Recruiting 1, Terminated 1, Unknown 1 |
| Phase 2 | 5 | Completed 3, Recruiting 1, Unknown 1 |
Follow Clofazimine: new trials by email Literature Review of Clofazimine trials Research Report on Clofazimine
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BDLL Chinese Cohort bedaquiline, delamanid, linezolid - Drug-resistant Tuberculosis, Pulmonary Tuberculosis | Phase 3 | Active not recruiting | Huashan Hospital | 120 | 2024-11-27 | 2025-09-02 |
| Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contezolid, Delamanid and Bedaquiline Cohort Bedaquiline, Delamanid, Contezolid - Pulmonary Tuberculosis, Rifampicin-resistant Tuberculosis | Phase 3 | Active not recruiting | Beijing Chest Hospital | 186 | 2023-12-22 | 2025-04-01 |
| RHB-204 for the Treatment of Pulmonary Mycobacterium Avium Complex Disease RHB-204, Placebo - Pulmonary Mycobacterium Avium Complex Infection, Bronchiectasis | Phase 3 | Terminated | RedHill Biopharma Limited | 12 | 2020-12-01 | 2025-03-18 |
| Economic Evaluation of New MDR TB Regimens Bedaquiline, Pretomanid, Moxifloxacin - Multi-drug Resistant Tuberculosis, Extensively Drug-Resistant Tuberculosis | Phase 2 / Phase 3 | Completed | Medecins Sans Frontieres, Netherlands | 73 | 2020-10-20 | 2024-04-22 |
| Evaluating Newly Approved Drugs in Combination Regimens for Multidrug-Resistant TB With Fluoroquinolone Resistance (endTB-Q) Bedaquiline 100 MG, Delamanid 50 MG Oral Tablet, Clofazimine 100 MG Oral Capsule - Tuberculosis, Multidrug-Resistant, Tuberculosis | Phase 3 | Completed | Médecins Sans Frontières, France | 323 | 2020-04-06 | 2025-02-10 |
| Finding the Optimal Regimen for Mycobacterium Abscessus Treatment Amikacin, Tigecycline, Imipenem - Pulmonary Disease Due to Mycobacteria (Diagnosis) | Phase 2 / Phase 3 | Recruiting | The University of Queensland | 300 | 2020-03-02 | 2026-05-11 |
| 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 Bedaquiline Oral Tablet, Linezolid Oral Tablet, Delamanid in Oral Dosage Form - Tuberculosis, Pre-XDR-TB | Phase 3 | Completed | Wits Health Consortium (Pty) Ltd | 402 | 2019-08-22 | 2024-08-28 |
| PRACTECAL-PKPD Sub Study Bedaquiline, Pretomanid, Moxifloxacin - Multi-drug Resistant Tuberculosis, Extensively Drug-Resistant Tuberculosis | Phase 2 / Phase 3 | Unknown | Medecins Sans Frontieres, Netherlands | 240 | 2019-08-06 | 2021-05-14 |
| Two-month Regimens Using Novel Combinations to Augment Treatment Effectiveness for Drug-sensitive Tuberculosis Rifampicin, Isoniazid, Pyrazinamide - Tuberculosis, Pulmonary | Phase 2 / Phase 3 | Completed | University College, London | 675 | 2018-03-21 | 2023-08-14 |
| Open Label Efficacy and Safety of Anti-MAP (Mycobacterium Avium Ssp. Paratuberculosis) Therapy in Adult Crohn's Disease RHB-104 (fixed-dose combination: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine) - Crohn Disease | Phase 3 | Completed | RedHill Biopharma Limited | 54 | 2017-03-18 | 2021-02-24 |
| Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s) Bedaquiline, Pretomanid, Moxifloxacin - Tuberculosis, Multidrug-Resistant, Extensively Drug-Resistant Tuberculosis | Phase 2 / Phase 3 | Completed | Medecins Sans Frontieres, Netherlands | 552 | 2017-01-01 | 2024-05-01 |
| Evaluating Newly Approved Drugs for Multidrug-resistant TB Bedaquiline, Delamanid, Clofazimine - Tuberculosis, Multidrug-Resistant, Infection, Bacterial | Phase 3 | Completed | Médecins Sans Frontières, France | 754 | 2016-12-01 | 2025-02-10 |
| The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB Regimen A locally-used WHO-approved MDR-TB regimen (2011 guideline), Moxifloxacin, Clofazimine - MDR-TB | Phase 3 | Completed | IUATLD, Inc | 588 | 2016-03-01 | 2023-09-28 |
| Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium Avium Complex Disease (MAC) Plus AIDS Ethambutol hydrochloride, Clarithromycin, Clofazimine - Mycobacterium Avium-intracellulare Infection, HIV Infections | Phase 3 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 400 | 2021-11-04 |
Tuberculosis, Multidrug-Resistant (8) · Tuberculosis, Pulmonary (8) · Extensively Drug-Resistant Tuberculosis (5) · Tuberculosis (4) · Bacterial Infections (2) · Lung Diseases (2) · Acquired Immunodeficiency Syndrome (1) · Bronchiectasis (1) · Crohn Disease (1) · Disease (1) · Gram-Positive Bacterial Infections (1) · HIV Infections (1) · Mycobacterium Infections (1) · Mycobacterium Infections, Nontuberculous (1) · Mycobacterium avium-intracellulare Infection (1)
Medecins Sans Frontieres, Netherlands (3) · Médecins Sans Frontières, France (2) · RedHill Biopharma Limited (2) · Beijing Chest Hospital (1) · Huashan Hospital (1) · IUATLD, Inc (1) · National Institute of Allergy and Infectious Diseases (NIAID) (1) · The University of Queensland (1) · University College, London (1) · Wits Health Consortium (Pty) Ltd (1)
South Africa (6) · India (4) · Belarus (3) · United States (3) · China (2) · Georgia (2) · Israel (2) · Kazakhstan (2) · Lesotho (2) · Pakistan (2) · Peru (2) · Singapore (2) · Uganda (2) · Uzbekistan (2) · Australia (1)
Carole Mitnick, Sc.D (2) · Lorenzo Guglielmetti, MD (2) · Andrew Nunn, PhD (1) · Bern Nyang'wa, MB BS, MPH (1) · Bern-Thomas Nyang'wa, MD (1) · Cohn D (1) · David Y Graham, MD (1) · Fisher E (1) · Francesca M Conradie (1) · Horsburgh CR (1) · Ira N Kalfus, MD (1) · June L Almenoff, MD, PhD (1) · Kevin L. Winthrop, MD, MPH (1) · Nicholas Paton (1) · Sarah Meredith, MD (1)
PMID 26929418, PMID 30102705, PMID 30865791, PMID 31676905, PMID 34489274, PMID 34563240, PMID 35028659, PMID 35698158, PMID 36546625, PMID 36808186, PMID 37980911, PMID 38037119, PMID 38462751, PMID 38842323, PMID 39879593, PMID 40414233, PMID 40683298, PMID 41917253, PMID 42270675, PMID 42341301