EUCTR2020-002545-42-DK进行中（未招募）1 期
ARISE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Validate Patient-Reported Outcome Instruments in Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium avium Complex (MAC) - ARISE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must satisfy all of the following criteria to be included in the study:
- •1. Male or female = 18 years of age (19 years or older in South Korea)
- •2. Current diagnosis of MAC lung infection (initial, second, or third infection event). MAC or mixed infection with MAC as the dominant species is allowed, with MAC as the intended organism for treatment
- •3. Positive sputum culture for MAC within 6 months prior to Screening
- •4. Positive sputum culture for MAC at Screening
- •5. A chest computed tomography (CT) scan, read locally, within 6 months prior to Screening to determine presence and size of pulmonary cavities. Subjects who do not have a chest CT scan within 6 months prior to Screening will be required to obtain a chest CT scan, read locally, during screening.
- •6. In the Investigator’s opinion, documented respiratory signs/symptoms at Screening that are attributable to the current MAC lung infection
- •7. An average QOL-B respiratory domain score of = 85 based on scores at Screening and on the day of enrollment prior to randomization
- •8. In the Investigator’s opinion, underlying lung disease (eg, chronic obstructive pulmonary disease [COPD], bronchiectasis) have been managed according to best local standard of care, and on stable maintenance therapy for a minimum of 4 weeks prior to randomization
- •9. Willingness and ability to adhere to a prescribed study treatment during the study
- •10. Ability to produce (spontaneously or with induction) approximately 2 mL of sputum for mycobacteriology at Screening
- •11. Women of child-bearing potential [WOCBP ] (ie, fertile following menarche and until becoming post-menopausal unless permanently sterile) and fertile men (ie, all men after puberty unless permanently sterile by bilateral orchidectomy) agree to practice highly effective method of birth control from Day 1 to at least 90 days after the last dose. Examples of such birth controls are:
- •- true abstinence [refraining from heterosexual intercourse during the entire study],
- •- copper intrauterine device [IUD],
- •- hormonal methods (levonorgestrel-releasing intrauterine system, progestogen implant, combined oral contraceptive pill [combined with barrier method],
- •- exclusive homosexual relationship, or
- •- sole male partner who has undergone surgical sterilization with confirmation of azoospermia at least 3 months post procedure) while participating in the study.
- •12. Provide signed informed consent prior to administration of study drugs or performing any study related procedure
- •13. Be able to comply with study drugs use, study visits, and study procedures as defined by the protocol
- •14. Men with partners who are WOCBP (pregnant or non-pregnant) agree to use condoms and non-pregnant partners should practice a highly effective method of birth control.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Subjects who meet any of the following criteria will be disqualified from entering the study:
- •1. Diagnosis of cystic fibrosis (CF)
- •2. History of more than 3 MAC lung infections
- •3. Received any mycobacterial antibiotic treatment for current MAC lung infection
- •4. Refractory MAC lung infection, defined as having positive MAC cultures while being treated with a multidrug mycobacterial antibiotic treatment regimen for a minimum of 6 consecutive months and no documented successful treatment, defined as negative sputum culture for MAC and cessation of treatment
- •5. Relapse of prior MAC lung infection, defined as positive sputum culture for MAC = 6 months of cessation of prior successful treatment
- •6. MAC isolate with MIC for liposomal amikacin = 128 µg/mL at Screening
- •7. Evidence of any pulmonary cavity = 2 cm in diameter, as determined by chest CT scan, read locally, within 6 months prior to Screening
- •8. Radiographic finding of new lobar consolidation, atelectasis, significant pleural effusion, or pneumothorax during routine clinical care within 2 months prior to Screening
- •9. Active pulmonary malignancy (primary or metastatic) or any malignancy requiring chemotherapy or radiation therapy within 1 year prior to Screening or anticipated during the study
- •10. Active pulmonary tuberculosis requiring treatment during Screening
- •11. Hospitalization for underlying lung disease during Screening
- •12. Acute pulmonary exacerbation (eg, COPD or bronchiectasis) requiring treatment with antibiotics, or corticosteroids (IV or oral), within 4 weeks prior to and during Screening
- •13. Predicted forced expiratory volume in 1 second (FEV1) < 35%, pre-bronchodilator use
- •14. Current smoker
- •15. History of lung transplantation
- •16. Use of inhaled or systemic aminoglycosides with activity against MAC (eg, amikacin, kanamycin, or streptomycin) during Screening
- •17. Prior exposure to ALIS (including clinical study)
- •18. Known hypersensitivity or contraindications to use to ALIS, aminoglycosides, or any of their excipients
- •19. Disseminated MAC infection
- •20. Positive pregnancy test or lactation at Screening. All WOCBP will be tested. Women not of child-bearing potential are defined as postmenopausal (ie, amenorrheic for 12 months without an alternative medical cause or confirmed by more than one follicle stimulating hormone [FSH] measurement), or naturally or surgically sterile through bilateral oophorectomy, hysterectomy, or bilateral salpingectomy. For women under the age of 45 years, confirmatory testing with FSH should be considered.)
- •21. Administration of any investigational drug within 8 weeks prior to Screening
- •22. Known or suspected acquired immunodeficiency syndromes (HIV-positive, regardless of CD4 counts). Other immunodeficiency syndromes that may interfere with study participation in the opinion of the Investigator
- •23. Significant (as determined by the Investigator) hearing loss, vestibular dysfunction, neuromuscular weakness or a diagnosis of myasthenia gravis, where the potential risk of aminoglycoside toxicity outweighs the potential benefit
- •24. Aspartate aminotransferase or alanine aminotransferase = 3 times the upper limit of normal (ULN) or total bilirubin = 1.5 times ULN at Screening
- •25. Absolute neutrophil count = 500/µL at Screening
- •26. Serum creatinine > 2 times ULN at Screening
- •27. Current alcohol, medication, or illicit drug abuse
- •28. Any condition that, in the opinion of the Investigator, interferes with ability to safely complete the study or adhere
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