7 completed, 3 active not recruiting, 2 terminated, 2 unknown. 16 Phase 2, 5 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 16 | Completed 7, Active not recruiting 3, Terminated 2, Unknown 2, Not yet recruiting 1, Recruiting 1 |
| Phase 3 | 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 |
|---|---|---|---|---|---|---|
| Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours), Ceftriaxone for Injection, Amoxicillin - Mycobacterium Abscessus Pulmonary Disease, Mycobacterium Abscessus Infection | Phase 2 | Not yet recruiting | The University of Queensland | 300 | 2027-04-01 | 2026-03-20 |
| Ultra-Short Course Bedaquiline, Clofazimine, Pyrazinamide and Delamanid Versus Standard Therapy for Drug-Susceptible Tuberculosis Bedaquiline (BDQ), Clofazimine (CFZ), Pyrazinamide (PZA) - Tuberculosis, Pulmonary, HIV | Phase 2 | Active not recruiting | Brigham and Women's Hospital | 94 | 2023-11-24 | 2026-08-05 |
| Linezolid Dosing Strategies in Drug-Resistant TB Linezolid 600 mg, Linezolid 1200 mg (QD), Linezolid 1200 mg (TIW) - Tuberculosis, Multidrug-Resistant, Tuberculosis | Phase 2 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 138 | 2022-09-27 | 2026-10-02 |
| Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine to Treat MDR-TB Delamanid, Levofloxacin, Bedaquiline - Tuberculosis, Multidrug-Resistant | Phase 2 | Active not recruiting | Boston University | 271 | 2022-06-07 | 2026-07-08 |
| Pharmacokinetic Study With a Loading Dose of Clofazimine in Adult Patients With Nontuberculous Mycobacterial Disease Clofazimine - Nontuberculous Mycobacterial Diseases | Phase 2 | Completed | Radboud University Medical Center | 12 | 2022-02-14 | 2023-08-16 |
| Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST Study Rifapentine, Rifampicin, Isoniazid - HIV, Tuberculosis | Phase 2 | Terminated | National Institute of Allergy and Infectious Diseases (NIAID) | 104 | 2021-11-05 | 2026-07-08 |
| 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 |
| Dual Therapy With Interferon Beta-1b and Clofazimine for COVID-19 Interferon beta-1b, Clofazimine - COVID-19 | Phase 2 | Unknown | The University of Hong Kong | 81 | 2020-07-14 | 2020-07-15 |
| 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 |
| 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 |
| A Phase 2A Evaluation of the Safety, Tolerability, Pharmacokinetics, Efficacy of Clofazimine (CFZ) in Cryptosporidiosis Clofazimine, Placebo - Cryptosporidiosis | Phase 2 | Terminated | University of Washington | 33 | 2017-12-14 | 2019-08-13 |
| Clofazimine in the Treatment of Pulmonary Mycobacterium Avium Complex (MAC) Clofazimine, sugar pill - Mycobacterium Avium Complex | Phase 2 | Active not recruiting | Oregon Health and Science University | 102 | 2017-04-11 | 2026-05-06 |
| 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 |
| Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With Clofazimine (C)-TMC207 (J)-PA-824 (Pa)-Pyrazinamide (Z) TMC207 (J), PA-824 (PA), pyrazinamide (Z) - Pulmonary Tuberculosis | Phase 2 | Completed | Global Alliance for TB Drug Development | 105 | 2012-10-01 | 2016-12-13 |
| A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium Avium Infection in HIV-Infected Individuals. Ciprofloxacin hydrochloride, Ethambutol hydrochloride, Amikacin sulfate - Mycobacterium Avium-intracellulare Infection, HIV Infections | Phase 2 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 90 | 2021-11-03 |
Tuberculosis, Pulmonary (7) · Tuberculosis, Multidrug-Resistant (5) · Extensively Drug-Resistant Tuberculosis (3) · Tuberculosis (3) · Mycobacterium Infections, Nontuberculous (2) · Mycobacterium avium-intracellulare Infection (2) · Acquired Immunodeficiency Syndrome (1) · COVID-19 (1) · Cryptosporidiosis (1) · Disease (1) · HIV Infections (1) · Infections (1) · Lung Diseases (1)
Medecins Sans Frontieres, Netherlands (3) · National Institute of Allergy and Infectious Diseases (NIAID) (3) · The University of Queensland (2) · Boston University (1) · Brigham and Women's Hospital (1) · Global Alliance for TB Drug Development (1) · Oregon Health and Science University (1) · Radboud University Medical Center (1) · The University of Hong Kong (1) · University College, London (1) · University of Washington (1)
South Africa (7) · Belarus (3) · Haiti (3) · Philippines (3) · India (2) · Malawi (2) · Netherlands (2) · Singapore (2) · Thailand (2) · United States (2) · Uzbekistan (2) · Australia (1) · Botswana (1) · Brazil (1) · China (1)
Andreas Diacon, MD (1) · Bern Nyang'wa, MB BS, MPH (1) · Bern-Thomas Nyang'wa, MD (1) · Charles Horsburgh, MD (1) · Constance A. Benson (1) · DM Parenti (1) · Ivan FN Hung, MD FRCP (1) · J Ellner (1) · John Metcalfe, MD, PhD, MPH (1) · Kevin Winthrop, MD (1) · Nicholas Paton (1) · Payam Nahid, MD (1) · Sean Wasserman, MBChB, PhD (1) · Sedona Sweeny (1)
PMID 25622149, PMID 30102705, PMID 30139372, PMID 32277809, PMID 34489274, PMID 34748385, PMID 35698158, PMID 36546625, PMID 36808186, PMID 37980911, PMID 38842323, PMID 39378281, PMID 40064371, PMID 40414233, PMID 40915311, PMID 41510291, PMID 41917253, PMID 42270675
U01AI152980 (1), U01AI170426 (1)