EUCTR2014-004788-18-NL进行中（未招募）1 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function
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
- 204
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 (males and females) will be aged 12 years or older on the
- •date of informed consent or, where appropriate, assent.
- •Heterozygous for F508del-CFTR and a second allele with a CFTR
- •mutation predicted to have residual function. The results of the
- •confirmatory genotype sample obtained at the Screening Visit must be
- •reviewed before randomization.
- •Forced Expiratory Volume in 1 Second (FEV1) greater than or equal to
- •(=) 40 percent (%) and less than or equal to (=) 90% of predicted
- •normal for age, sex, and height during screening.
- •Sweat chloride value = 60 mmol/L from test results obtained during
- •screening OR as documented in the subject's medical record.
- •If the sweat chloride value is <60 mmol/L, there must be documented
- •evidence of chronic sinopulmonary disease.
- •Stable CF disease as judged by the investigator
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 174
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •History of any comorbidity that, in the opinion of the investigator,
- •might confound the results of the study or pose an additional risk in
- •administering study drug to the subject
- •An acute upper or lower respiratory infection, pulmonary exacerbation,
- •or changes in therapy (including antibiotics) for pulmonary disease
- •within 28 days before Day 1
- •A 12-lead electrocardiogram (ECG) demonstrating corrected QT
- •interval (QTc) greater than (>) 450 milliseconds (msec) at the Screening
- •History of solid organ or hematological transplantation
- •History or evidence of cataract, lens opacity, Y-suture, or lamellar
- •rings determined to be clinically significant by the ophthalmologist
- •during the ophthalmologic examination during the Screening Period. If
- •the subject has documentation of bilateral lens removal, an
- •ophthalmologic examination is not required and this criterion is not
- •applicable.
- •Ongoing or prior participation in an investigational drug study
- •(including studies investigating VX-661, lumacaftor [VX-809], and/or
- •ivacaftor) or use of commercially available CFTR modulator (e.g.,
- •Kalydeco) within 30 days of screening
- •Use of restricted medications or foods within the specified window
- •before the first dose of study drug
- •Pregnant and nursing females (females of childbearing potential must
- •have a negative pregnancy test at Screening and Day 1).
- •Sexually active subjects of reproductive potential who are not willing
- •to follow the contraception requirements
- •Colonization with organisms associated with a more rapid decline in
- •pulmonary status
研究者
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