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

这个子项目是许多利用 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。约55家中心的约260例患者将以1：1的比例随机分配接受吡非尼酮2403 mg或安慰剂等效药物，每日3次，TID，分次给药，与食物同服。主要结局变量为用力肺活量FVC预测值百分比从基线至第60周的绝对变化。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，患者将从随机化时起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。

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 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.