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Clinical trial

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

NCT01856634 is registered in ClinicalTrials.gov with Otsuka Pharmaceutical Development & Commercialization, Inc. as lead sponsor.

NCT NCT01856634
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Registry record

As filed in ClinicalTrials.gov.

Title
Phase 1, Open-label, Multiple-dose, and Age De-escalation Trial to Assess the Pharmacokinetics, Safety and Tolerability of Delamanid (OPC 67683) in Pediatric Multidrug-resistant Tuberculosis Patients on Therapy With an Optimized Background Regimen of Anti-tuberculosis Drugs
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Phase
Phase 1
Overall status
Completed
Start date
June 14, 2013
Completion date
December 28, 2017
Enrollment
37 (actual)
Sites
2

Conditions

As the registry lists them; a condition with its own page is linked.

multidrug resistant tuberculosis, pediatric