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: 21 Sep 2018
At a glance
- Drugs Delamanid (Primary) ; Antituberculars
- Indications Tuberculosis
- Focus Pharmacokinetics
- Sponsors Otsuka Pharmaceutical Development & Commercialization
- 27 Jan 2018 Status changed from recruiting to completed.
- 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.