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
Active, no longer recruiting
Phase of Trial: Phase II
Latest Information Update: 01 Feb 2018
At a glance
- Drugs Delamanid (Primary) ; Antituberculars
- Indications Tuberculosis
- Focus Adverse reactions; Pharmacokinetics
- Sponsors Otsuka Pharmaceutical Development & Commercialization
- 27 Jan 2018 Status changed from recruiting to active, no longer recruiting.
- 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.