Phase 2, Open-label, Multiple-dose Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Delamanid (OPC-67683) in Pediatric Multidrug-resistant Tuberculosis Patients on Therapy With an Optimized Background Regimen of Anti-tuberculosis Drugs Over a 6-Month Treatment Period

Trial Profile

Phase 2, Open-label, Multiple-dose Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Delamanid (OPC-67683) in Pediatric Multidrug-resistant Tuberculosis Patients on Therapy With an Optimized Background Regimen of Anti-tuberculosis Drugs Over a 6-Month Treatment Period

Recruiting
Phase of Trial: Phase II

Latest Information Update: 22 Mar 2017

At a glance

  • Drugs Delamanid (Primary) ; Antituberculars
  • Indications Tuberculosis
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Otsuka Pharmaceutical Development & Commercialization
  • Most Recent Events

    • 10 Mar 2017 Planned End Date changed from 1 Nov 2019 to 1 Feb 2020.
    • 10 Mar 2017 Planned primary completion date changed from 1 Nov 2018 to 1 Feb 2020.
    • 12 Feb 2016 Planned number of patients changed from 12 to 36 as reported by ClinicalTrials.gov.
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