Phase 1, Open-label, Multiple-dose, and Age De-escalation Trial to Assess the Pharmacokinetics, Safety and Tolerability of Delamanid (OPC 67683) in Paediatric Multidrug-resistant Tuberculosis Patients on Therapy With an Optimized Background Regimen of Anti-tuberculosis Drugs

Trial Profile

Phase 1, Open-label, Multiple-dose, and Age De-escalation Trial to Assess the Pharmacokinetics, Safety and Tolerability of Delamanid (OPC 67683) in Paediatric Multidrug-resistant Tuberculosis Patients on Therapy With an Optimized Background Regimen of Anti-tuberculosis Drugs

Recruiting
Phase of Trial: Phase I

Latest Information Update: 22 Mar 2017

At a glance

  • Drugs Delamanid (Primary) ; Antituberculars
  • Indications Tuberculosis
  • Focus Pharmacokinetics
  • Most Recent Events

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