Overview

A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB)

Status:
Completed
Trial end date:
2020-01-13
Target enrollment:
Participant gender:
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).
Phase:
Phase 2
Details
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.