EUCTR2016-004996-33-ES进行中（未招募）1 期
A Phase 4, Open-label Treatment, Randomized, Multicenter, 2-arm, Parallelgroup, Pilot Study of Adherence to Lumacaftor/Ivacaftor in CF Subjects Homozygous for the F508del-CFTR Mutation
Vertex Pharmaceuticals Incoporated0 个研究点目标入组 75 人开始时间: 2017年3月10日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
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. Subject and/or legally appointed and authorized representative (e.g., parents or legal guardian) will sign and date an informed consent form (ICF) and where appropriate, an assent form.
- •2. Subject and/or legally appointed and authorized representative (e.g., parent or legal guardian) is willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures.
- •3. Confirmed diagnosis of CF and homozygous for the F508del-CFTR mutation at Screening.
- •4. Subjects (male and female) will be aged 16 years and older on the date of informed consent or, where appropriate, assent.
- •5. FEV1 =40% of predicted normal for age, sex, and height at Screening.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 15
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. History of any illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering LUM/IVA to the subject, e.g., history of advanced liver disease.
- •2. Presence of moderate or severe hepatic impairment (Child-Pugh Class B or C).
- •3. Subjects currently receiving invasive mechanical ventilation.
- •4. Known history of alcohol or drug abuse in the past year, including but not limited to cannabis, cocaine, and opiates, as deemed by the investigator.
- •5. Any of the following abnormal laboratory values during screening:
- •o Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 × ULN o ALT or AST >3 × ULN with total bilirubin >2 × ULN o Glomerular filtration rate =30 mL/min/1.73 m2. This will be calculated by the Modification of Diet in Renal Disease study equation for subjects =18 years of age and calculated by the Counahan-Barratt equation for subjects aged 12 to 17 years.
- •6. Pregnant or nursing females (females of childbearing potential must have a negative pregnancy test at screening and Day 1).
- •7. Female subjects and female partners of male subjects who plan to become pregnant during Treatment Period or within 90 days following the last dose of LUM/IVA.
- •8. Sexually active subjects of reproductive potential who are not willing to follow the contraception requirements outlined in Section 11.5.7.1.
- •9. History of solid organ or hematological transplantation.
- •10. Ongoing or prior participation in an investigational drug study (including studies
- •investigating LUM and/or IVA) within 30 days of screening
- •- A washout period of 5 terminal half-lives of the previous investigational LUM/IVA or 30 days, whichever is longer
- •- The duration of the elapsed time may be longer if required by local regulations.
- •11. Current use of commercial LUM/IVA combination therapy.
- •12. Subject, or close relative of the subject, is the investigator or a subinvestigator, research assistant, pharmacist, study coordinator, or other staff directly involved with the conduct of the study at that site.
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