NCT06004037已完成2 期
A Phase 2a, Open-label, Single-arm, Multi-center Study to Evaluate the Efficacy and Safety of LCB01-0371 (Delpazolid) as Add-on Therapy in Patients With Refractory Mycobacterium Abscessus Complex Pulmonary Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 7
- 主要终点
- semi-quantitative scale (SQS) change versus baseline
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of delpazolid add-on therapy in Patients with Refractory Mycobacterium abscessus Complex Pulmonary disease
详细描述
Delpazolid, which demonstrates effects similar to other oxazolidinone-class drugs and has confirmed good safety, aims to evaluate its efficacy in MABC-PD patients who are unresponsive to guideline-based treatments
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-screening: Adults aged 19 years or above
- •Pre-screening: Patients diagnosed with MABC (including subspecies abscessus, bolletii, and massiliense) pulmonary disease in radiologic and microbiologic evaluations
- •LCB01-0371 MIC ≤ 8 μg/mL for MABC
- •Patients who continue to show positivity for MABC even after treatments based on the guidelines of ATS/ERS/ESCMID/IDSA for at least 6 months prior to screening, and who meet all of the following criteria:
- •Patients who have been confirmed positive at least once in the last sputum or bronchoscopy sample culture performed prior to screening
- •Patients who have not achieved culture conversion (at least 3 consecutive negative mycobacteria cultures in the sputum or bronchoscopy sample collected at an interval of at least 4 weeks) within 6 months prior to screening
- •Patients who can voluntarily expectorate sputum at screening
- •Patients with a life expectancy of 12 weeks or more
- •Patients with adequate organ function who meet the following criteria:
- •Hemoglobin > 9.0 g/dL (without transfusion within 2 weeks prior to measurement)
- •Absolute neutrophil count ≥ 1,500/µL (without administration of G-CSF within 2 weeks prior to measurement)
- •Platelet ≥ 100,000/µL
- •Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
- •Alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤ 2.5 × ULN
- •Serum creatinine ≤ 1.5 × ULN or creatinine clearance >30 mL/min (calculated with the Cockcroft-Gault formula)
- •Patients who voluntarily provided a written consent to participate in the clinical study
排除标准
- •Patients who cannot swallow the study drug tablet due to dysphagia, nasogastric tube insertion, etc.
- •Patients diagnosed with cystic fibrosis
- •Patients who have received a lung transplant
- •Patients with disseminated or extrapulmonary nontuberculous mycobacteria
- •Patients with known active pulmonary tuberculosis
- •Patients with NTM infections other than MABC
- •Patients with an active pulmonary malignancy within 1 year prior to screening or Patients with other malignancies that require chemotherapy or radiotherapy
- •Patients who has received linezolid for MABC treatment within 3 months prior to screening
- •Patients with known HIV positivity or a suspected infection thereof or Patients with a known active hepatitis B or C infection
- •Patients who currently have a clinically significant cardiovascular disease
- •Patients with severe cardiac failure (New York Heart Association [NYHA] class III/IV) that occurred within 24 weeks prior to screening
- •Patients with pulmonary embolism or deep venous thrombosis that occurred within 24 weeks prior to screening
- •Patients whose multidrug therapy for treatment of MABC was changed within 4 weeks prior to screening (Discontinuation, dose adjustment, change of administration route, etc., are allowed.)
- •Patients for whom the administration of contraindicated concomitant drugs that correspond to the following cannot be discontinued during the clinical study or for whom their administration is necessary
- •Administration of a new antibacterial agent for the prioritized treatment of NTM, especially MABC, other than background therapy
- •Monoamine oxidase inhibitors
- •Serotonin reuptake inhibitor or serotonin 5-HT1 receptor agonists
- •Meperidine or buspirone
- •Drugs that lower epilepsy threshold; tramadol, etc.
- •Tricyclic Antidepressant
- •Other investigational products: If there is a history of administration within 30 days prior to screening, it falls under the exclusion criteria.
- •Pregnant or breastfeeding women and women of childbearing potential who do not agree to practice appropriate contraceptive methods*:
研究组 & 干预措施
delpazolid
Experimental
In addition to background therapy for MABC, patients will be given orally three tablets (400 mg/tablet) of LCB01-0371 for 12 weeks.
干预措施: Delpazolid (Drug)
结局指标
主要结局
semi-quantitative scale (SQS) change versus baseline
时间窗: 12 weeks
The SQS using liquid media and solid media will be scored a point of 1-7, with lower scores representing a reducing bacterial load.
次要结局
- Change from baseline in SQS(4 weeks and 8 weeks)
- Sputum culture conversion rate(12 weeks)
- Time to culture conversion(12 weeks)
- Time to positivity in the liquid culture automated system (MGIT)(12 weeks)
- Negative sputum culture rate at each time point after baseline(12 weeks)
- Change from baseline in the inflammatory marker(12 weeks)
- Change from baseline in the CT score(12 weeks)
- Quality of Life Questionnaire-Bronchiectasis(12 weeks)
- Six-minute walk test(12 weeks)
- Extended administration(After 12 weeks)
研究者
研究点 (7)
Loading locations...
相似试验
招募中
3 期
A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus ErythematosusSystemic Lupus ErythematosusNCT06617325UCB Biopharma SRL450
已完成
3 期
A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus ErythematosusSystemic Lupus ErythematosusNCT04294667UCB Biopharma SRL321
终止
2 期
Efficacy, Safety and Tolerability of PF-06687234 as Add-on Therapy to Infliximab in Active UC Subjects Not in Remission.Ulcerative ColitisNCT03269695Pfizer20
尚未招募
1 期
Dalpiciclib Isethionate Tablets Combined With Abiraterone Acetate Tablets (I) and Prednisone Tablets (AA-P) Versus Placebo Combined With AA-P in Treatment of High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)NCT06099990Jiangsu HengRui Medicine Co., Ltd.660
终止
1 期
A Phase Ib Study of AZD5462 on Top of Dapagliflozin in Participants With Heart Failure and Moderate Renal ImpairmentRenal ImpairmentHeart FailureNCT06639087AstraZeneca8