EUCTR2012-001571-36-CZ进行中（未招募）1 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER). - RAINIER
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
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.Male or female subjects from 45 to 85 years of age
- •2.A confident diagnosis of IPF consistent with diagnostic criteria described in the 2011 American Thoracic Society/European Respiratory Society (ATS/ERS) Consensus Statement. HRCT or surgical lung biopsy data will be interpreted by a central service. The term surgical lung biopsy” encompasses biopsies obtained at open thoracotomy and thoracoscopy, as well as, cryobiopsies obtained through bronchcoscopy. The diagnosis of IPF must be made within 3 years prior to screening, or if diagnosis was made > 3 years prior to screening, there must be evidence of clinical worsening within 12 months prior to screening, as judged by the investigator.
- •3.6MWD = 50 meters (164 feet): use of = 6 L/min supplemental O2 is permitted for all subjects.
- •4.Able to maintain O2 saturation of = 89% while breathing room air at rest at sea level. If the study site is located at more than 1000 meters above sea level, the subject must be able to maintain O2 saturation of = 89% while on 2 liters of supplemental oxygen at rest (eligible subjects are permitted to use supplemental oxygen during sleep and on exertion based on the clinical judgment of the investigator, to a maximum of 6 liters/minute).
- •5.Able to perform complete breath hold for diffusing lung capacity so that a carbon monoxide (DLCO) measurement can be safely undertaken
- •6.Negative serum pregnancy test at screening and negative urine pregnancy test at randomization for female subjects of childbearing potential
- •7.Willingness of female subjects of childbearing potential to undergo urine pregnancy tests at each study visit starting at Randomization
- •8.Females of childbearing potential must agree to use highly effective methods of contraception from the screening visit throughout the study period and for 90 days following the last dose of IMP. Please refer to Section 8.11.2 for protocol recommended methods of contraception; females of childbearing potential must have negative serum ß hCG at screening.
- •9.Non-vasectomized male subjects must agree to use a highly effective method of contraception if sexually active with a partner who is of child bearing potential. Subjects must refrain from sperm donation from Randomization throughout the study period until 90 days following the last dose of investigational medicinal product (IMP).
- •10.Lactating females must agree to discontinue nursing before enrolling in the study and for the duration of the study while receiving IMP.
- •11.Competency to understand the information given in the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved Informed Consent Form (ICF); subjects must sign the form prior to the initiation of any study procedures, unless the assessment is performed as standard of care for this disease.
- •Are the trial subjects under 18? no
- •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 125
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 375
排除标准
- •1. Pregnant or breastfeeding
- •2. Clinically significant respiratory diseases other than IPF, including asbestosis, other pneumoconiosis or hypersensitivity pneumonitis
- •3. Obstructive lung disease determined by Pulmonary Function Test (PFTs) or HRCT as follows:
- •- Evidence of reactive airway disease by an increase in forced expiratory volume in 1 second (FEV1) following bronchodilator challenge that exceeds both 200 ml AND exceeds a 12% increase from the pre-bronchodilator value
- •FEV1/FVC ratio < age adjusted lower limit of normal (LLN)
- •Residual volume (RV) > 120% by plethysmography (see Section 6.5 for alternative methods)
- •Significant emphysema on HRCT defined as more emphysema than fibrosis interpreted by a central radiology service
- •4. FVC > 90%
- •5. Hemoglobin corrected, not volume corrected, (DLCO) <25% of predicted normal
- •6. Surgical lung biopsy (SLB) diagnostic for pneumoconiosis, hypersensitivity pneumonitis
- •nonspecific interstitial pneumonia or other idiopathic interstitial lung disease
- •7. Any clinically diagnosed collagen vascular disease
- •8. History of aortic aneurysm = 3.5cm in diameter
- •9. History of cerebrovascular accident (stroke) within the preceding 26 weeks
- •10. Clinically significant heart disease defined as a myocardial infarction documented by an ST
- •elevation (STEMI) on electrocardiogram (ECG) within 6 months prior to screening,
- •percutaneous coronary intervention or coronary artery bypass surgery within 6 months prior
- •to screening, unstable angina pectoris, congestive heart failure (NYHA class III/IV or known
- •left ventricular ejection fraction < 25%), right heart failure, significant right ventricular
- •hypertrophy, or uncontrolled arrhythmia
- •11. Require pharmaceutical treatment for pulmonary hypertension
- •12. Hospitalization for acute respiratory illness < 26 weeks prior to screening, unless reviewed
- •with the Medical Monitor
- •13. Aspiration pneumonia < 26 weeks prior to screening
- •14. Active or recent (< 4 weeks prior to Screening and/or during the screening period) respiratory
- •bacterial, viral, fungal, or other infection (defined as exhibiting ongoing signs/symptoms
- •related to the infection and without improvement) (Must not meet this criterion at time of
- •Randomization)
- •15. Active work-up for suspected lung cancer or history of cancer or precancerous state
- •(eg, familial polyposis, BRCA1, BRCA2, carcinoma in-situ) within 5 years prior to screening
- •except for the following:
- •Definitive prophylactic surgery for precancerous state
- •Excision of non melanomatous skin cancer treated with clear margins
- •Prostate carcinoma treated with surgery or radiation with normal PSA for 24 months, not
- •requiring either chemotherapy or hormone therapy
- •16. History of human immunodeficiency virus (HIV), or active hepatitis C or hepatitis B
- •infection. Subjects with hepatitis C who have had successful curative therapy will be eligible
- •17. Co-morbid condition or illness limiting life expectancy to < 2 years at time of screening
- •18. Major surgery, as defined by the investigator, < 30 days prior to screening. Scheduled major
- •elective surgery during the expected duration of the study should be discussed with the
- •Gilead Medical Monitor.
- •19. History or evidence of a clinically significant disorder, condition, or disease that, in the
- •opinion of the investigator and the Gilead Medical Monitor, would pose a risk to subject
- •safety or interfere with the study evaluations, procedures, or completion
- •20. Current
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