jRCT2071220118暂停不适用
A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter, Prospective Study to Assess the Efficacy, Safety, and Pharmacokinetics of Orally Administered Epetraborole in Patients with Treatment-refractory Mycobacterium avium Complex Lung Disease (MACrO2)
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 60
- 主要终点
- By-subject sputum conversion monthly through Month 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Male or female patients who are 18 years of age or older.
- •Willing and able to provide written informed consent.
- •Patients with a diagnosis of treatment-refractory MAC lung disease consisting of all of the following (a) Microbiological, (b) Clinical, and (c) Radiographic criteria:
- •a. Microbiological criteria:
- •One Pre-Study MAC-positive respiratory specimen. Documentation of a MAC positive specimen collected per standard of care within 6 months prior to signing the informed consent form (ICF).
- •One Screening MAC-positive expectorated or induced sputum sample.
- •b. Clinical criteria: At least 2 of the following patient-reported clinical symptoms:
- •Cough with sputum production
- •Cough without sputum
- •Chest congestion
- •Hemoptysis
- •Night sweats or unusual sweating
- •c. Radiographic criteria: Non contrast Chest CT scan within 6 months prior to signing the ICF with abnormalities consistent with MAC lung disease.
- •d. OBR criteria: An OBR is a combination regimen that consists of >-2 antimycobacterial agents. The patient-specific OBR must be administered for a minimum duration of 6 consecutive months that is either ongoing at the time of Screening or was stopped or paused no more than 12 months before screening. The OBR regimen administered during Screening must be continued after randomization.
- •Patients who are willing to comply with all the study activities and procedures throughout the duration of the study and comply with all planned study visits and study procedures from Screening through the LFU Visit.
- •All patients must agree to use an effective method of birth control.
- •Patients expected to survive with continued antimycobacterial therapy and appropriate supportive care from Screening through the LFU Visit, in the judgment of the Investigator.
排除标准
- •Patients with a presence of any suspected or confirmed disease or condition at Screening or the time of randomization that, in the opinion of the Investigator, may confound the assessment of symptom-based clinical response.
- •Patients with active pulmonary malignancy or any malignancy that required or would require chemotherapy or radiation therapy within 1 year prior to randomization through the LFU Visit.
- •Patients with creatinine clearance (CrCl) of <-30 mL/min, as estimated by the Cockcroft Gault formula, at Screening.
- •Patients with hemoglobin <10.0 g/dL or <6.2 mmol/L at Screening; donation of blood or plasma within 28 days prior to randomization; or symptomatic loss of blood or hemorrhage within 28 days prior to randomization.
- •Patients with severe hemoptysis within 28 days prior to randomization, defined as >100 mL over any 24-hour period or severe or extremely severe hemoptysis.
- •Patients with severe hepatic impairment, as evidenced by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 x upper limit of normal (ULN) or total bilirubin >2 x ULN, or clinical signs of cirrhosis or end-stage hepatic disease.
- •Patients who are pregnant or breastfeeding.
- •Patients with a mean QT interval corrected using Fridericia's formula (QTcF) >480 msec based on triplicate 12-lead ECGs at Screening.
- •Patients with an immunodeficiency or an immunocompromised condition and risk for an opportunistic pulmonary infection.
- •Patients with an anticipated start of new non-study antimycobacterial therapy to be administered at any time between Screening and Month
- •Patients who have received any investigational medication during the 30 days or 5 half-lives, whichever is longer, prior to randomization.
- •Patients with any prior exposure to epetraborole.
- •Patients with any condition that, in the opinion of the Investigator, interferes with the ability to safely complete the study or adhere to study requirements, including the patient's inability or unwillingness to comply with all study assessments and visits.
结局指标
主要结局
By-subject sputum conversion monthly through Month 6
时间窗: Month 6
By-subject sputum conversion monthly through Month 6 in the Micro-ITT Population
By-subject sputum conversion based on 3 consecutive monthly negative sputum cultures for MAC by Month 6
时间窗: Month 6
By-subject sputum conversion based on 3 consecutive monthly negative sputum cultures for MAC by Month 6 in the Micro-ITT Population
次要结局
未报告次要终点
研究者
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