Trial intelligence / Profile preview

Delamanid + OBR in Children With MDR-TB

NCT03141060Phase 2Completed

Sponsor
National Institute of Allergy and Infectious Diseases
Start
Feb 2019
Primary completion
Apr 2025
Modality
Small Molecules
Countries
3
01

Overview

Phase 2, open-label trial of delamanid in multidrug-resistant tuberculosis (MDR-TB) (4 cohorts), sponsored by National Institute of Allergy and Infectious Diseases. Primary endpoints: Percentage of Participants With Adverse Events of >= Grade 3 Severity at Week 24, Percentage of Participants With Adverse Events of >= Grade 3 Assessed to be at Least Possibly Related to the Study Drug at Week 24 and 5 more. Started Feb 2019; status: completed.

02

Drugs

delamanid
03

Conditions

multidrug-resistant tuberculosis (MDR-TB)

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