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A Multicenter, Phase 2b/c, Open-label, Randomized, Dose-finding Trial to Evaluate the Safety and Efficacy of a 4 Month Regimen of OPC-167832 in Combination With Delamanid and Bedaquiline in Subjects With Drug-susceptible Pulmonary Tuberculosis in Comparison With Standard Treatment

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Trial Profile

A Multicenter, Phase 2b/c, Open-label, Randomized, Dose-finding Trial to Evaluate the Safety and Efficacy of a 4 Month Regimen of OPC-167832 in Combination With Delamanid and Bedaquiline in Subjects With Drug-susceptible Pulmonary Tuberculosis in Comparison With Standard Treatment

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 15 Apr 2025

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At a glance

  • Drugs Bedaquiline (Primary) ; Delamanid (Primary) ; Quabodepistat (Primary) ; Ethambutol; Isoniazid; Pyrazinamide; Rifampicin
  • Indications Pulmonary tuberculosis
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Otsuka Pharmaceutical Development & Commercialization

Most Recent Events

  • 27 Jun 2024 Status changed from active, no longer recruiting to completed.
  • 21 Mar 2024 According to an Otsuka Pharmaceutical Development & Commercialization Media Release, full results of this phase 2b/c, randomized trial are expected by the end of 2024.
  • 21 Mar 2024 According to an Otsuka Pharmaceutical Development & Commercialization Media Release, this study is being held across six clinical research sites in South Africa.

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