Otsuka Pharmaceutical Development & Commercialization, Inc.
Deltyba™, Delamanid, OPC-67683
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A Phase 3, Multicenter,Randomized, Double-blind, Placebo-controlled, Parallel Group Trial to Evaluate the Safety and Efficacy of Delamanid Administered Orally as 200 mg Total Daily Dose for Six Months in Patients With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis The purpose of this trial is to evaluate the efficacy of Delamanid administered orally as 100 mg twice daily (BID) for 2 months followed by 200 mg once daily (QD) for 4 months in combination with an optimized background regimen (OBR) versus placebo with OBR during the 6-month intensive phase of MDR-TB treatment. This trial is a multicenter, randomized, double-blind, stratified, placebo-controlled trial conducted globally in 2 parallel groups at approximately 15 sites qualified to treat MDR-TB. In addition, a subtrial comprised of human immunodeficiency virus (HIV) positive patients who will be on antiretrovirals (ARVs) during the trial and will be randomized to OBR plus placebo or OBR plus Delamanid will be conducted at a limited number of these sites that have been prequalified as having an integrated approach to TB and HIV treatment and management and a sufficient population of MDR-TB patients co-infected with HIV for enrollment.