Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis
Фаза 2
Прекращено
NCT05971602
| Заболевание | Pulmonary Tuberculosis |
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| Фаза | Фаза 2 |
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| Спонсор | Gates Medical Research Institute |
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| Статус | Прекращено |
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| Участники | 93 участн. |
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| Вмешательство | Delamanid, Bedaquiline, OPC-167832, and Sutezolid (DBOS), Pretomanid, Bedaquiline, OPC-167832, and Sutezolid (PBOS), Isoniazid, Rifampicin, Pyrazinamide, Ethambutol (HRZE), Pretomanid or Delamanid, Bedaquiline, OPC-167832, and Sutezolid (XBOS), Isoniazid and Rifampicin (HR) |
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| Дата начала | 26.07.2023 |
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| Дата завершения | 6.02.2025 |
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| Публикация результатов | 20.05.2026 |
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Кратко
This multicenter, two-stage, open-label, randomized trial will aim to assess the efficacy, safety, optimal duration, and pharmacokinetics (PK) of Delamanid, Bedaquiline, OPC-167832, and Sutezolid (DBOS) and Pretomanid, Bedaquiline, OPC-167832, and Sutezolid (PBOS) in adult participants with drug sensitive tuberculosis (DS-TB) and rifampicin or multi-drug resistant TB (RR/MDR-TB).
Percentage of Participants With DS-TB Reporting ≥ Grade 3 Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Two weeks after the end of treatment [19 weeks for Arm 1 (DBOS) and Arm 2 (PBOS), and 28 weeks for Arm 3 (HRZE)] · percentage of participants
| Arm 1: Delamanid + Bedaquiline + OPC-167832 + Sutezolid (DBOS) | 16.7 percentage of participants |
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| Arm 2: Pretomanid + Bedaquiline + OPC-167832 + Sutezolid (PBOS) | 6.3 percentage of participants |
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| Arm 1: Delamanid + Bedaquiline + OPC-167832 + Sutezolid (DBOS) | 10 percentage of participants |
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| Arm 2: Pretomanid + Bedaquiline + OPC-167832 + Sutezolid (PBOS) | 3.1 percentage of participants |
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| Arm 3: HRZE-Regimen | 6.5 percentage of participants |
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| Arm 3: HRZE-Regimen | 6.5 percentage of participants |
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Percentage of Participants With Pulmonary DS-TB With Unfavorable Outcome Status
Through Week 17 post-randomization for Arm 1 (DBOS) and Arm 2 (PBOS), and Week 26 post-randomization for Arm 3 (HRZE) · Percentage of participants
| Arm 1: Delamanid + Bedaquiline + OPC-167832 + Sutezolid (DBOS) | 9.1 Percentage of participants |
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| Arm 2: Pretomanid + Bedaquiline + OPC-167832 + Sutezolid (PBOS) | 0 Percentage of participants |
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| Arm 3: HRZE-Regimen | 18.8 Percentage of participants |
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| Unstratified treatment differences | -9.7 (95% CI -37.0–13.9) |
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