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
NCT03141060
| Condition | Tuberculosis, HIV Infections |
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| Phase | Phase 1/2 |
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| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
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| Status | Completed |
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| Enrollment | 37 participants |
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| Interventions | Delamanid, Optimized multidrug background regimen (OBR) for children with MDR-TB |
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| Start date | Feb 18, 2019 |
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| Completion date | Apr 22, 2025 |
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| Results posted | Jun 25, 2026 |
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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.
Percentage of Participants With Adverse Events of ≥ Grade 3 Severity
Measured from entry through Week 24 · percentage of participants
| Cohort 1 (>=12 to < 18 Years) | 18.2 percentage of participants |
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| Cohort 2 (>=6 to < 12 Years) | 25.0 percentage of participants |
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| Cohort 3 (>=3 to < 6 Years) | 33.3 percentage of participants |
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| Cohort 4 (>=0 to < 3 Years) | 25.0 percentage of participants |
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Percentage of Participants With Adverse Events of ≥ Grade 3 Assessed by the Core Team to be at Least Possibly Related to the Study Drug
Measured from entry through Week 24 · percentage of participants
| Cohort 1 (>=12 to < 18 Years) | 9.1 percentage of participants |
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| Cohort 2 (>=6 to < 12 Years) | 25.0 percentage of participants |
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| Cohort 3 (>=3 to < 6 Years) | 0.0 percentage of participants |
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| Cohort 4 (>=0 to < 3 Years) | 0.0 percentage of participants |
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Percentage of Participants Who Were Terminated From Study Treatment Due to a Drug-related Adverse Event
Measured from entry through Week 24 · percentage of participants
| Cohort 1 (>=12 to < 18 Years) | 9.1 percentage of participants |
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| Cohort 2 (>=6 to < 12 Years) | 12.5 percentage of participants |
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| Cohort 3 (>=3 to < 6 Years) | 0.0 percentage of participants |
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| Cohort 4 (>=0 to < 3 Years) | 0.0 percentage of participants |
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