Clinical Trials Logo

Clinical Trial 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).


Clinical Trial Description

This study will assess the safety, tolerability, pharmacokinetics, and efficacy of delamanid plus an optimized background regimen in pediatric participants with MDR-TB over a 6-month treatment period. This long-term study, an extension of Study 242-12-232, will be conducted in participants who have completed Study 242-12-232. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01859923
Study type Interventional
Source Otsuka Pharmaceutical Development & Commercialization, Inc.
Contact
Status Completed
Phase Phase 2
Start date July 20, 2013
Completion date January 13, 2020

See also
  Status Clinical Trial Phase
Recruiting NCT05017324 - Sequencing Mycobacteria and Algorithm-determined Resistant Tuberculosis Treatment Trial N/A
Active, not recruiting NCT02496572 - Effectiveness of a Simplified Short Regimen for Multidrug Resistant Tuberculosis in Uzbekistan Phase 3
Completed NCT03942354 - Patient-reported Experiences and Quality of Life Outcomes in the TB-PRACTECAL Clinical Trial
Completed NCT02454205 - An Open-label RCT to Evaluate a New Treatment Regimen for Patients With Multi-drug Resistant Tuberculosis Phase 2/Phase 3
Recruiting NCT05081401 - Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)
Completed NCT01856634 - Pharmacokinetic and Safety Trial to Determine the Appropriate Dose for Pediatric Patients With Multidrug Resistant Tuberculosis Phase 1
Active, not recruiting NCT03867136 - Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T) Phase 4
Not yet recruiting NCT04484129 - MDR-TB Close Contacts Tracing in China (TCCT Study)
Completed NCT00727844 - Linezolid to Treat Extensively-Drug Resistant Tuberculosis Phase 2
Active, not recruiting NCT04421495 - Safety and Effectiveness of Delamanid-containing Regimen for MDR-TB Patients in China Phase 4
Active, not recruiting NCT04717908 - Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T)-PLUS N/A
Not yet recruiting NCT03604848 - NGS-Guided(G) Regimens(R) of Anti-tuberculosis(A) Drugs for the Control(C) and Eradication(E) of MDR-TB N/A
Recruiting NCT02120638 - Optimization of MDR-TB Treatment Regimen Based on the Molecular Drug Susceptibility Results of Pyrazinamide Phase 3
Recruiting NCT05534750 - Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis (TEDITUB) Phase 2