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
Phase of Trial: Phase I
Latest Information Update: 22 Mar 2017
At a glance
- Drugs Delamanid (Primary) ; Antituberculars
- Indications Tuberculosis
- Focus Pharmacokinetics
- 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.