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Clinical Trial Summary

The purpose of this trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of long-term (6-month) treatment with delamanid plus an optimized background regimen (OBR) of other anti-tuberculosis drugs in pediatric participants who completed Study 242-12-232 (NCT01856634).


Clinical Trial Description

This study will assess the safety, tolerability, pharmacokinetics, and efficacy of delamanid plus an optimized background regimen in pediatric participants with MDR-TB over a 6-month treatment period. This long-term study, an extension of Study 242-12-232, will be conducted in participants who have completed Study 242-12-232. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01859923
Study type Interventional
Source Otsuka Pharmaceutical Development & Commercialization, Inc.
Contact
Status Completed
Phase Phase 2
Start date July 20, 2013
Completion date January 13, 2020

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