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A Phase IIa Trial to Evaluate the Safety, Tolerability, Extended Early Bactericidal Activity and Pharmacokinetics of 14 Days' Treatment With Four Oral Doses of PA-824 in Adult Participants With Newly Diagnosed, Uncomplicated, Smear-Positive, Pulmonary Tuberculosis

Trial Profile

A Phase IIa Trial to Evaluate the Safety, Tolerability, Extended Early Bactericidal Activity and Pharmacokinetics of 14 Days' Treatment With Four Oral Doses of PA-824 in Adult Participants With Newly Diagnosed, Uncomplicated, Smear-Positive, Pulmonary Tuberculosis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Oct 2019

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At a glance

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

    • 30 Sep 2019 Results of Modeling and Simulation of Pretomanid Pharmacodynamics in Pulmonary Tuberculosis Patients using data from PA-824-CL-007 and PA-824-CL-010 studies, published in the Antimicrobial Agents and Chemotherapy
    • 24 May 2010 Results have been published in Antimicrobial Agents and Chemotherapy.
    • 28 Oct 2008 Primary endpoint 'Bacteriological response rate' has been met.
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