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

NCT01856634 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2018-01-30

No results posted yet for this study

Summary

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.

Conditions

  • Multidrug Resistant Tuberculosis
  • Pediatric

Interventions

DRUG

100 mg Delamanid

100 mg Delamanid BID for 10 days

DRUG

50 mg Delamanid

50 mg Delamanid BID for 10 days

DRUG

25 mg Pediatric Formulation Delamanid

25 mg Pediatric Formulation Delamanid BID for 10 days

DRUG

10 mg Delamanid Pediatric Formulation

Patients \> 10 kg will receive DPF 10 mg BID for 10 days

DRUG

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

DRUG

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

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Principal Investigators

  • Jeffrey Hafkin, MD · Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-14
Primary Completion
2017-12-10
Completion
2017-12-28

Countries

  • Philippines
  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01856634 on ClinicalTrials.gov