37
Participants
Start Date
June 14, 2013
Primary Completion Date
December 10, 2017
Study Completion Date
December 28, 2017
100 mg Delamanid
100 mg Delamanid BID for 10 days
50 mg Delamanid
50 mg Delamanid BID for 10 days
25 mg Pediatric Formulation Delamanid
25 mg Pediatric Formulation Delamanid BID for 10 days
10 mg Delamanid Pediatric Formulation
Patients \> 10 kg will receive DPF 10 mg BID for 10 days
5 mg Delamanid Pediatric Formulation
"Patients \> 8 kg and ≤ 10 kg will receive DPF 5 mg BID for 10 days~Patients ≤ 8 kg will receive DPF 5 mg QD for 10 days"
Optimized Background Regimen
Selection and administration of the treatment medications (i.e. OBRs) will be based on WHO's Guidelines for the programmatic management of drug-resistant TB, in conjunction with national TB program guidelines in each country
De La Salle Health Sciences Institute, Dasmariñas
Brooklyn Chest Hospital, Ysterplaat
Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY