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
1/2期
已完成
NCT03141060
| 适应症 | Tuberculosis, HIV Infections |
|---|
| 分期 | 1/2期 |
|---|
| 申办方 | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|
| 状态 | 已完成 |
|---|
| 受试者人数 | 37 人 |
|---|
| 干预（药物） | Delamanid, Optimized multidrug background regimen (OBR) for children with MDR-TB |
|---|
| 开始日期 | 2019年2月18日 |
|---|
| 完成日期 | 2025年4月22日 |
|---|
| 结果公布日 | 2026年6月25日 |
|---|
摘要
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 |
|---|
| Cohort 2 (>=6 to < 12 Years) | 25.0 percentage of participants |
|---|
| Cohort 3 (>=3 to < 6 Years) | 33.3 percentage of participants |
|---|
| Cohort 4 (>=0 to < 3 Years) | 25.0 percentage of participants |
|---|
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 |
|---|
| Cohort 2 (>=6 to < 12 Years) | 25.0 percentage of participants |
|---|
| Cohort 3 (>=3 to < 6 Years) | 0.0 percentage of participants |
|---|
| Cohort 4 (>=0 to < 3 Years) | 0.0 percentage of participants |
|---|
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 |
|---|
| Cohort 2 (>=6 to < 12 Years) | 12.5 percentage of participants |
|---|
| Cohort 3 (>=3 to < 6 Years) | 0.0 percentage of participants |
|---|
| Cohort 4 (>=0 to < 3 Years) | 0.0 percentage of participants |
|---|
在 BENITIONS 中查看
查看 ClinicalTrials.gov 原文
全部试验
本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。