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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这是一项吡非尼酮在IPF患者中的III期、随机化、双盲、安慰剂对照、安全性和疗效研究。将在约55家中心随机分配约260例患者，比例为1：1，接受吡非尼酮2403 mg或安慰剂等效药物，每日3次分次给药-TID随餐给药。主要结局变量为从基线至第60周用力肺活量-FVC预测值百分比的绝对变化。患者将按地理区域随机分组。 任何确定参加研究的患者必须在筛选前至少28天停用所有禁用药物。 一旦患者完成洗脱期，他们就可以进入可能持续长达42天的筛选期。如果有资格参加，患者将从随机化开始接受研究治疗（吡非尼酮或安慰剂），持续60周。随后将进行为期4周的随访。