EUCTR2015-004986-99-GB进行中（未招募）1 期
A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Investigating the Optimal Dose Regimen, Efficacy, and Safety of Adding Oral Cysteamine in Adult Patients with Cystic Fibrosis (CF) Being Treated for an Exacerbation of CF-associated Lung Disease.
ovaBiotics, Ltd0 个研究点目标入组 120 人开始时间: 2016年9月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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. CF-associated lung disease with documented history of chronic infection with Gram-negative organism(s)
- •2. Established patient of the Principal Investigator's CF Multi-Disciplinary team
- •3. Age equal or greater than 18 years
- •4. Weight equal or more than 40 Kg
- •5. FEV1 more than 30% of predicted within the 6 months prior to study exacerbation
- •6. At baseline visit: experiencing a new exacerbation of CF associated lung disease requiring treatment that includes an aminoglycoside antibiotic
- •7) Females of childbearing potential will be included if they are
- •either sexually inactive (sexually abstinent for 14 days prior to the
- •first study drug dose continuing through 28 days after the last
- •study drug dose, or using one of the following highly effective
- •contraceptive (i.e. results in <1% failure rate when used
- •consistently and correctly) methods in this trial:
- •a. intrauterine device (IUD);
- •b. surgical sterilization of the partner (vasectomy for 6 months
- •c. combined (estrogen or progestogen containing) hormonal
- •contraception associated with the inhibition of ovulation
- •(either oral, intravaginal, or transdermal);
- •d. progestogen only hormonal contraception associated with the
- •inhibition of ovulation (either oral, injectable, or
- •implantable);
- •e. intrauterine hormone releasing system (IUS);
- •f. bilateral tubal occlusion.
- •Females of childbearing potential agree to remain sexually inactive or to keep the same birth control method for at least 28 days following
- •the last dose.
- •9) A female of non-childbearing potential must have undergone one
- •of the following sterilization procedures at least 6 months prior to
- •the first study drug dose:
- •a. hysteroscopic sterilization;
- •b. bilateral tubal ligation or bilateral salpingectomy;
- •c. hysterectomy;
- •d. bilateral oophorectomy;
- •or be postmenopausal with amenorrhea for at least 1 year prior
- •to the first study drug dose and follicle stimulating hormone
- •(FSH) serum levels consistent with postmenopausal status.
- •10) A non-vasectomized male subject agrees to use a condom with
- •spermicide or abstain from sexual intercourse during the study
- •until 90 days beyond the last dose of study medication and the
- •female partner agrees to comply with inclusion 7 or 9. For a
- •vasectomized male who has had his vasectomy 6 months or more
- •prior to study start, it is required that they use a condom during
- •sexual intercourse. A male who has been vasectomized less than 6
- •months prior to study start must follow the same restrictions as a
- •non-vasectomized male.
- •11) If male, agrees not to donate sperm from the first study drug dose until 90 days after dosing.
- •12) Willing and able to comply with all protocol requirements and
- •procedures, including induction of sputum, if necessary
- •13) Willing and able to provide signed and dated informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- 另有 3 项未显示
排除标准
- •1. Hypersensitive to cysteamine or to any of the excipients
- •2. Hypersensitive to penicillamine
- •3. Transplant recipient
研究者
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A study to identify whether it is safe, if it works, and how much and how often cysteamine should be given to adult patients with Cystic Fibrosis (CF) who are being treated for a worsening of CF associated lung disease.exacerbation of Cystic FibrosisMedDRA version: 19.0Level: PTClassification code 10070608Term: Infective pulmonary exacerbation of cystic fibrosisSystem Organ Class: 10021881 - Infections and infestationsEUCTR2015-004986-99-ITovaBiotics, Ltd120
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