EUCTR2020-002545-42-DE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. 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 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 a 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 (HIVpositive, 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 to s
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