# A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB)

> **NCT01859923** · PHASE2 · COMPLETED · sponsor: **Otsuka Pharmaceutical Development & Commercialization, Inc.** · enrollment: 37 (actual)

## Conditions studied

- Multidrug Resistant Tuberculosis

## Interventions

- **DRUG:** Delamanid
- **DRUG:** Delamanid Pediatric Formulation (DPF)
- **DRUG:** Optimized Background Regimen (OBR)

## Key facts

- **NCT ID:** NCT01859923
- **Lead sponsor:** Otsuka Pharmaceutical Development & Commercialization, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2013-07-20
- **Primary completion:** 2020-01-13
- **Final completion:** 2020-01-13
- **Target enrollment:** 37 (ACTUAL)
- **Last updated:** 2020-11-23


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01859923

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01859923, "A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB)". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT01859923. Licensed CC0.

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