CLINICAL TRIAL: PHASE 3 STUDY OF SAFETY AND EFFICACY OF PIRFENIDONE IN PATIENTS

临床试验：吡非尼酮对患者安全性和有效性的第 3 阶段研究

• 批准号: 7950737
• 负责人: MARK Louis BRANTLY
• 金额: $ 0.63万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7950737
• 关键词: Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Dose; Double-Blind Method; Food; Funding; Geographic Locations; Grant; Institution; Patients; Pharmaceutical Preparations; Phase; Phase III Clinical Trials; Pirfenidone; Placebo Control; Placebos; Randomized; Research; Research Personnel; Resources; Safety; Screening procedure; Source; Time; United States National Institutes of Health; Vital capacity; follow-up; primary outcome; safety study

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a Phase 3, randomized, double-blind, placebo controlled, safety and efficacy study of pirfenidone in patients with IPF. Approximately 260 patients at approximately 55 centers will be randomly assigned, ratio of 1:1 to receive pirfenidone 2403 mg or placebo equivalent administered in divided doses three times per day-TID with food. The primary outcome variable will be the absolute change in percent predicted forced vital capacity-FVC from Baseline to Week 60. Patients will be randomized by geographic region. Any patient identified for the study must be off all prohibited medications at least 28 days before screening. Once patients complete the washout period, they may enter the screening period that may last up to 42 days. If eligible to participate, patients will receive study treatment, pirfenidone or placebo, from the time of randomization for 60 weeks. This will be followed by a 4 week follow-up period.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 这是一项第三阶段，随机，双盲，安慰剂控制，吡啶酮对IPF患者的安全性和有效性研究。大约260名患者将随机分配大约55个中心，1：1的比率为1：1，接受pirfenidone 2403 mg或安慰剂等效剂量，分别以每天三次用食物给药。主要结果变量将是预测从基线到60周的强迫能力-FVC百分比的绝对变化。患者将由地理区域随机分配。 在筛查前至少28天，必须将确定为研究的任何患者均可消除所有禁止的药物。 一旦患者完成洗涤期，他们可能会进入最多可持续42天的筛查期。如果有资格参加，患者将从60周的随机时间开始接受研究治疗，吡啶酮或安慰剂。随后将进行4周的随访期。