Clinical trialNCT01856634CompletedPhase 1Interventional

Pharmacokinetic and Safety Trial to Determine the Appropriate Dose for Pediatric Patients With Multidrug Resistant Tuberculosis

SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.Enrollment37Multidrug Resistant TuberculosisPediatric

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of this trial is to determine the pediatric dose of delamanid that is equivalent to the adult dose already shown to be effective against multidrug-resistant tuberculosis.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Jeffrey Hafkin, MD
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

2 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Philippines

de la Salle Health Sciences Institute
Dasmariñas, Cavite, Philippines

South Africa

Brooklyn Chest Hospital
Ysterplaat, Cape Town, South Africa

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

10 mg Delamanid Pediatric Formulation100 mg Delamanid25 mg Pediatric Formulation Delamanid5 mg Delamanid Pediatric Formulation50 mg DelamanidOptimized Background Regimen

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 14 Jun 2013
Primary completion: 10 Dec 2017
Completion: 28 Dec 2017
Last update posted: 30 Jan 2018
Registered enrollment: 37
Registry id: NCT01856634

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.