EUCTR2016-001785-29-IE进行中（未招募）1 期
Combined Effect of CFTR Modifiers and Intensive Antibiotic Treatment
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •1.1Inclusion Criteria
- •Adult, greater or equal to 18 years of age
- •Documentation of a CF diagnosis with the R117H CFTR mutation on at least 1 allele and any known or unknown second mutation other than G551D. CF diagnosis is defined as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
- •a.sweat chloride = 60 mEq/liter by quantitative pilocarpine iontophoresis test (QPIT)
- •b.two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
- •c.Abnormal nasal potential difference (change in NPD in response to a low chloride solution and isoproteronol of less than -5 mV)
- •Prior chronic Pa or Sa in the sputum as defined by > 50% of prior sputum cultures with each organism in the year prior to enrollment. Patients need a minimum of 2 prior cultures in the year.
- •Able to expectorate sputum
- •Be clinically stable at the time of initiation of ivacaftor (Visit 1)
- •Be off chronic inhaled or oral antibiotics (other than azithromycin) for 2 weeks prior to free enrollment
- •Patients must be able to tolerate planned antibiotic regimen (anti-Staphylococcal and anti-Pseudomonas aeruginosa regimens)
- •Written informed consent and assent if indicated obtained from subject or subject’s legal representative, able to communicate with the Investigator and comply with the requirements of the protocol
- •If female and of childbearing potential, must have a negative pregnancy test on Day 1(Start of Treatment) prior to receiving study drug
- •If female and of childbearing potential, is willing to use adequate contraception for the duration of the study and for 1 month following the study, as determined by the investigator
- •If male and able to father a child, is willing to use adequate contraception for the duration of the study and for 1 month following the study, as determined by the investigator
- •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 14
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Participation in the VX-770-105, VX-770-106, VX-770-108, VX-770-109, VX-770-110, VX-770-111, VX-770-112, or VX-770-113 study, VX-770 Extended Access Program, VX-661-108, or use of ivacaftor within 6 months prior to Visit 1.
- •Any upper or lower respiratory symptoms requiring treatment with oral, inhaled or IV antibiotics within the 2 weeks prior to Visit 1.
- •History of solid organ transplantation.
- •Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
- •History of massive hemoptysis (>240 mL) within 72 hours of Visit 3.
- •Inability to produce sputum
- •Females who have a positive pregnancy test at Visit 2, are lactating, or are not practicing (or willing to practice) a medically acceptable form of contraception (acceptable forms of contraception: hormonal birth control, intrauterine device, barrier method plus a spermicidal agent or abstinence) from Visit 2 through Visit 7 unless surgically sterilized or postmenopausal.
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