Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis
2상
조기 종료
NCT05971602
| 대상 질환 | Pulmonary Tuberculosis |
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| 임상 단계 | 2상 |
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| 스폰서 | Gates Medical Research Institute |
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| 상태 | 조기 종료 |
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| 참여자 수 | 93 명 |
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| 중재(약물) | 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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| 시작일 | 2023년 7월 26일 |
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| 완료일 | 2025년 2월 6일 |
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| 결과 공개일 | 2026년 5월 20일 |
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요약
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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