EUCTR2008-002352-20-BE进行中（未招募）不适用
Single center, double-blind, randomized, placebo-controlled, two-period/two-treatment crossover study investigating the effect of miglustat on the nasal potential difference in patients with cystic fibrosis homozygous for the F508del mutation
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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
- •Aged 12 years and older
- •Male or female
- •Non-pregnant women who are to remain non-pregnant for 3 months after the end of the study. Women of childbearing potential must use a reliable method of contraception. Reliable methods of contraception for female patients include the following:
- •- barrier type devices (e.g., female condom, diaphragm and contraceptive sponge) used ONLY in combination with a spermicide
- •- intrauterine devices
- •- oral contraceptive agent
- •- Depo-Provera TM (medroxyprogesterone acetate)
- •- levonorgestrel implants
- •Abstention, the rhythm method or contraception by the partner alone are NOT reliable methods of contraception. A woman is considered to have child-bearing potential unless she meets at least one of the following criteria:
- •- 6 weeks post-surgical bilateral salpingo-oophorectomy or hysterectomy
- •- Premature ovarian failure confirmed by a specialist gynecologist
- •- Age > 50 years and not treated with any kind of HRT for at least 2 years prior to screening, and with amenorrhea for at least 24 consecutive months prior to screening and a serum FSH level of > 40 IU/L at screening.
- •- Age > 55 years and treated with HRT prior to screening with an appropriate medical documentation of spontaneous amenorrhea for at least 24 months.
- •For female patients in the pediatric age range, a reliable method of contraception must be considered, if appropriate.
- •Male patients accepting for the duration of the study and for 3 months thereafter to use a condom and not to procreate a child (not in case of azoospermia)
- •Cystic fibrosis patients homozygous for the F508del mutation as confirmed by genetic test
- •Signed informed consent prior to any study-mandated procedure.
- •Are the trial subjects under 18? yes
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any condition prohibiting the correct measurement of the NPD such as upper respiratory tract infection
- •Acute upper respiratory tract or pulmonary exacerbation requiring antibiotic intervention within 2 weeks of screening
- •Severe renal impairment (creatinine clearance < 30 mL/min as per Cockroft and Gault)
- •Female patients of childbearing potential who will not undergo a pregnancy test prior to enrollment into the study
- •History of significant lactose intolerance
- •History of neuropathy
- •Presence of clinically significant diarrhea (> 3 liquid stools per day for > 7 days) without definable cause within 1 month prior to screening
- •Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease
- •FEV1 < 25% of predicted normal
- •Oxygen saturation at rest < 88%
- •Active or passive smoking as measured using the Smokelyzer®
- •Hypersensitivity to miglustat or any excipients
- •Planned treatment or treatment with another investigational drug or therapy (e.g., gene therapy) within 1 month prior to randomization
- •Breast-feeding, pregnant women or women who plan to become pregnant during the course of the study
研究者
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