PIRFENIDONE AND PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF)

吡非尼酮和特发性肺纤维化 (IPF) 患者

• 批准号: 7950773
• 负责人: MARK Louis BRANTLY
• 金额: $ 0.08万
• 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/7950773
• 关键词: Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Dose; Eligibility Determination; Funding; Geographic Locations; Grant; Hamman-Rich syndrome; Institution; Patients; Pirfenidone; Protocols documentation; Research; Research Personnel; Resources; Source; United States National Institutes of Health; Visit; follow-up; meetings; open label; treatment duration

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 an open-label, multicenter, extension study for patients with idiopathic pulmonary fibrosis-IPF who complete the CAPACITY Trials, either PIPF-004 or PIPF-006. Eligible patients must complete the Final Follow-Up Visit for the CAPACITY studies and meet all of the eligibility criteria noted in this protocol. The duration of treatment for each patient will be variable and will continue until pirfenidone is commercially available in a geographic region, the study is terminated by the sponsor for reasons outlined in Section 3.9 of the sponsor?s protocol, or approximately 2.5 years have elapsed since the patient?s first dose of pirfenidone, whichever is shortest.

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。 这是一项针对特发性肺纤维化IPF患者的开放标签，多中心扩展研究，他们完成了能力试验，无论是PIPF-004或PIPF-006。 符合条件的患者必须完成对容量研究的最终随访，并符合本协议中指出的所有资格标准。 每位患者的治疗持续时间将是可变的，并且将继续持续到地理区域的吡啶酮在商业上可用，该研究由赞助商终止，出于赞助商方案的3.9节中概述的原因，或者自从患者最初是最短的pirfenidone剂量以来，已经经过了大约2.5年的时间。