Current preclinical and clinical development of Cfz for TB indications
| Phase | Date | Trial name (identifier) | Sponsor | Design | Treatment arms (Cfz daily dose) | Primary endpoint |
|---|---|---|---|---|---|---|
| Phase III | 2011–2016 | STREAM (ISRCTN78372190)17 | International Union Against Tuberculosis and Lung Disease | Non-inferiority | Bangladesh regimen16 vs locally used WHO MDR-TB regimen (Cfz=50–100 mg) | Proportion of patients with a favourable outcome (cure or completion) 27 months after randomisation |
| Phase II | 2012–2013 | NC-003 (NCT01691534)50 | Global Alliance for TB Drug Development | Superiority | Bedaquiline (J), PA-824 (PA), Z, Cfz vs. J-PA-Z vs. J-PA-Cfz vs. J-Z-Cfz vs. Z alone vs. Cfz alone vs. Rifafour (Cfz=100–300 mg) | Early bactericidal activity (rate of change of log CFU per mL sputum) |
Cfz, clofazimine; CFU, clofazimine; MDR-TB, multidrug-resistant tuberculosis; TB, tuberculosis.