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A Phase 2 Trial to Evaluate the Early Bactericidal Activity, Safety and Tolerability of the Following: TMC207 Plus PA-824 Plus Pyrazinamide Plus Clofazimine, TMC207 Plus PA-824 Plus Pyrazinamide, TMC207 Plus PA-824 Plus Clofazimine Alone, TMC207 Plus Pyrazinamide Plus Clofazimine, Pyrazinamide Alone, and Clofazimine Alone; in Adult Patients With Newly Diagnosed, Smear-Positive Pulmonary Tuberculosis

Trial Profile

A Phase 2 Trial to Evaluate the Early Bactericidal Activity, Safety and Tolerability of the Following: TMC207 Plus PA-824 Plus Pyrazinamide Plus Clofazimine, TMC207 Plus PA-824 Plus Pyrazinamide, TMC207 Plus PA-824 Plus Clofazimine Alone, TMC207 Plus Pyrazinamide Plus Clofazimine, Pyrazinamide Alone, and Clofazimine Alone; in Adult Patients With Newly Diagnosed, Smear-Positive Pulmonary Tuberculosis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 01 Apr 2022

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At a glance

  • Drugs Bedaquiline (Primary) ; Clofazimine (Primary) ; Pretomanid (Primary) ; Pyrazinamide (Primary) ; Rifampicin/isoniazid/pyrazinamide/ethambutol
  • Indications Pulmonary tuberculosis
  • Focus Therapeutic Use
  • Most Recent Events

    • 16 Feb 2022 Results of joint concentration-QTcF model of BDQ, CFZ, and PRET evaluating the QT-prolonging effect of all three, presented at the 29th Conference on Retroviruses and Opportunistic Infections
    • 19 Apr 2021 Results (n=15) assessing the effect of clofazimine exposure on QT prolongation, published in the Antimicrobial Agents and Chemotherapy
    • 03 Aug 2020 Results of a population PK analysis assessing PK of clofazimine and data were obtained from participants with pulmonary TB enrolled in two studies: EBA trial (Phase 2A early bactericidal activity study of clofazimine alone or in combination with bedaquiline, pretomanid and pyrazinamide and PROBex study (prospective observational cohort study of adults treated with bedaquiline) published in the Journal of Antimicrobial Chemotherapy
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