NL-OMON43501已完成3 期
An Open-Label Safety Extension Study to a Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients with Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium avium complex (MAC) That are Refractory to Treatment - INS-312
lnsmed lncorporated0 个研究点目标入组 1 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Subjects are eligible to participate in the study if they meet all the following inclusion criteria:
- •1. have successfully completed the Month 6 and EOT visits in INS-212
- •2. have not achieved the INS-212 protocol definition of culture conversion (3 consecutive monthly negative sputum cultures) by Month 6 in INS-212
- •have experienced a relapse or recurrence (agar positive or more than 2 consecutive broth positive results after culture conversion has occurred) by Month 6 in INS-212
- •3. have demonstrated compliance with treatment regimen in INS-212, including LAI, if applicable
- •4. willing to adhere to multi-drug treatment regimen during the course of the study
- •5. female of child bearing potential agrees to practice an acceptable method of birth control (e.g., true abstinence [refraining from heterosexual intercourse during the study], hormonal or barrier
- •methods, partner sterilization, or intrauterine device [IUD]) while participating in the trial. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of the study, and withdrawal are not acceptable methods of contraception.
- •6. the subject will provide written informed consent
- •7. willing to have serum and sputum specimens stored
- •8. able to comply with study drug use, study visits, and study procedures as determined by the Investigator
排除标准
- •Subjects are not eligible to participate in the study if they meet any of the following criteria:
- •1. achieved culture conversion without relapse or recurrence in the INS212study by Month 6
- •2. early discontinuation (prior to Month 6 study visit) from INS-212
- •3. met any of the exclusion criteria of the INS-212 study, with the exception of the following:
- •a. unable to perform the 6MWT
- •b. prior exposure to LAI (including clinical study)
- •c. in the opinion of the Investigator, patients who are not expected to survive the duration of the study
- •d. active allergic bronchopulmonary mycosis or any other condition requiring chronic systemic corticosteroids at a dose greater than the equivalent of 10 mg/day of prednisone within 3 months before Baseline (Day 1)
- •e. initiation of chronic therapy (e.g., high dose ibuprofen, inhaled anti-inflammatory agents including steroids, low dose maintenance steroids, rhDNase) at Baseline (Day 1)
- •4. positive pregnancy test or lactation. All women of child bearing potential will be tested. Women not of child bearing potential are defined as postmenopausal (i.e., amenorrheic for at least 1 year), or surgically or naturally sterile.
- •5. significant (as determined by the Investigator) hearing loss, vestibular dysfunction, or neuromuscular weakness where the potential risk of aminoglycoside toxicity outweighs the potential benefit
- •6. aspartate aminotransferase or alanine aminotransferase * 3 times the upper limit of normal (ULN) and/or total bilirubin * 2 times the ULN at their Month 6 study visit in INS-212
- •7. absolute neutrophil count *500/*L at their Month 6 study visit in INS2128. serum creatinine >2 times ULN at their Month 6 study visit in INS-212
- •9. current alcohol, medication abuse, or illicit drug abuse
- •10. any condition that, in the opinion of the Investigator, interferes with ability to safely complete the study or adhere to study requirements
- •11. diagnosis of myasthenia gravis
研究者
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