drugset / Trial / NCT03141060
Evaluating the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination With Optimized Multidrug Background Regimen (OBR) for Multidrug-Resistant Tuberculosis (MDR-TB) in Children With MDR-TB With and Without HIV
Phase 1/2
Completed
37 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Otsuka Pharmaceutical Development & Commercialization, Inc. · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This Phase I/II study evaluated the pharmacokinetics, safety, and tolerability of the anti-tuberculosis (TB) drug delamanid (DLM) in combination with an optimized multidrug background regimen (OBR) for multidrug-resistant tuberculosis (MDR-TB) in children with MDR-TB with and without HIV.
Timeline
- Start
- 2019-02-18
- Primary completion
- 2025-04-22
- Completion
- 2025-05-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Delamanid | Small molecule | 15 mg | Oral |
| Subject | Delamanid | Small molecule | 25 mg | Oral |
| Subject | Delamanid | Small molecule | 50 mg | Oral |
| Subject | Delamanid | Small molecule | 100 mg | Oral |