EUCTR2017-003723-29-IT进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 415
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. Documentation of a CF diagnosis as evidenced by 1 or more clinical features consistent with the CF phenotype and 1 or more of the following criteria:
- •a. Sweat chloride = 60 mEq/L by quantitative pilocarpine iontophoresis test
- •b. Two known disease-causing mutations in the CFTR gene.
- •2. Twelve years of age or older at the time Informed Consent/Assent is signed.
- •3. Weight = 40 kg.
- •4. FEV1 = 40% predicted and < 100 % predicted within the last 12 months.
- •5. Physician-initiated treatment with an IV antibiotic 2 or 3 times in the last 12 months for a new PEx.
- •6. As an alternative to inclusion criterion 5, physician-initiated treatment with an IV antibiotic 1 time in the last 12 months plus physician-initiated treatment with oral antibiotic(s) 1 or more times in the past 12 months for a new PEx.
- •7. Completion of the last course of antibiotics prescribed for any PEx = 28 days before Visit 1.
- •8. Able to perform pulmonary function tests. Optional use of a bronchodilator before testing is allowed to facilitate testing if the bronchodilator is used consistently starting with Visit 1.
- •9. Willing to provide repeat sputum specimens. If a subject is unable to reliably spontaneously expectorate sputum, induced sputum collection is acceptable. Optional collection of induced sputum specimens is allowed if induced sputum specimens are consistently collected starting with Visit 1. Adolescents should try to produce sputum spontaneously and can opt out of sputum induction.
- •10. Willing not to use any cannabinoids or any illegal substance of abuse from screening through Visit 9.
- •11. Women of childbearing potential must not be pregnant or breastfeeding at Visit 1 and must be using at least one highly effective or an acceptable method of contraception (failure rate < 1% per year) for at least 28 days before Visit 1 and be willing to continue to use at least one highly effective or an acceptable method of contraception throughout the study and for at least 28 days after discontinuation of study drug.
- •12. Male participants must be willing to follow contraceptive requirements and should not get anyone pregnant while they are taking the study product or within 28 days after taking the last dose of the study product, during which time period they or their partner must be willing to use at least one highly effective or an acceptable method of contraception.
- •13. Able to adhere to the study visit schedule and other protocol requirements.
- •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 353
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Severe or unstable CF at screening or Visit 1, such as:
- •a. Change in dose, or initiation of any new chronic therapy for CF lung disease within 28 days before Visit 1
- •b. Treatment with any systemic corticosteroids > 10 mg per day prednisone or equivalent within 14 days before Visit 1
- •c. Actively listed on an organ transplant list or have had an organ transplant other than corneal transplant.
- •2. Significant diseases or conditions other than CF that may influence response to the study drug or safety, such as:
- •a. Active hepatitis B or C infection
- •b. Human immunodeficiency virus infection
- •c. A history of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy = one year before Visit 1.
- •3. Subject's with a history of any seizure within the last 2 years.
- •4. Pregnant, trying to become pregnant or lactating female.
- •5. Current evidence of alcohol abuse (defined as 4 or more drinks per day on at least 4 days of the week) or history of abuse of illegal and/or legally prescribed drugs such as barbiturates, benzodiazepines, amphetamines, cocaine, or opioids during the 1 year before screening.
- •6. Any investigational agent within 30 days or five therapeutic half-lives of that agent whichever is longer, before Visit 1
- •7. Any of the following values for laboratory tests at screening:
- •a. A positive pregnancy test
- •b. Hemoglobin < 10 g/dL in males and < 9 g/dL in females.
- •c. Neutrophils < 1.0 x 1000,000,000/L
- •d. Platelets < 75 x 1000,000,000/L
- •e. Creatinine clearance < 50 ml/min according to Modification of Diet in Renal Disease (MDRD) Study equation in adults and Schwartz eGFR
- •formula in adolescent population.
- •f. Serum transaminases > 2.5 x upper normal limit
- •8. Any other condition or concurrent medical therapy at screening or Visit 1 that causes the investigator to determine it is not safe for the subject to participate or that may influence response to study drug or interfere with study assessments.
研究者
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