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

Phase 2 Completed 37 enrolled Otsuka Pharmaceutical Development & Commercialization, Inc.

Non-randomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start: 2013-07-20
Primary completion: 2020-01-13
Completion: 2020-01-13

Publications

Garcia-Prats AJ, Frias M, van der Laan L, De Leon A, Gler MT, Schaaf HS, Hesseling AC, Malikaarjun S, Hafkin J. Delamanid Added to an Optimized Background Regimen in Children with Multidrug-Resistant Tuberculosis: Results of a Phase I/II Clinical Trial. Antimicrob Agents Chemother. 2022 May 17;66(5):e0214421. doi: 10.1128/aac.02144-21. Epub 2022 Apr 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Delamanid	Small molecule	5 mg	Oral
Subject	Delamanid	Small molecule	10 mg	Oral
Subject	Delamanid	Small molecule	25 mg	Oral
Subject	Delamanid	Small molecule	50 mg	Oral
Subject	Delamanid	Small molecule	100 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications