An Open-Label Extension Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,058
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Adverse Events
研究概览
简要总结
This is an open-label, multi-center, extension study for patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone. The purpose of this study is to obtain additional safety data for pirfenidone 2403 mg/day in patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone.
详细描述
This is an open-label, multi-center, extension study for patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone. Eligible patients must complete the final visit for their qualifying study, have not permanently discontinued study drug in their qualifying study, and meet all of the eligibility criteria noted in this protocol.
Since data from the qualifying study may remain blinded during patient enrollment in PIPF-012, all patients will be treated as if they were taking placebo in their qualifying study. At the start of PIPF-012 participation, each patient will escalate the dose of pirfenidone.
The duration of treatment for each patient will vary and will continue until pirfenidone is commercially or otherwise available in his/her geographic region or the study is terminated by the sponsor for reasons outlined in the protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completes the qualifying clinical study final visit
- •In the opinion of the principal investigator (PI), has been generally compliant with study requirements during the qualifying study, or must be considered eligible to enroll in PIPF-012 by the InterMune medical monitor
- •Is able to provide informed consent and comply with the requirements of the study
排除标准
- •Is pregnant or lactating
- •Has known hypersensitivity to any of the components of the study drug
- •Starts participation in another interventional clinical trial between the end of participation in the qualifying InterMune clinical trial and entry into PIPF-012
- •Receives concomitant and/or excluded medications as defined in the protocol
- •Permanently discontinues study drug during the qualifying study for any reason before study completion
研究组 & 干预措施
Treatment
pirfenidone
干预措施: pirfenidone (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events
时间窗: 7.5 years
An adverse event defined as any unfavorable, harmful, or pathologic change in a research participant administered a pharmaceutical study treatment as indicated by physical signs, symptoms, and/or clinically significant laboratory abnormalities that occurred during the treatment and the post-treatment period, regardless of suspected cause.
次要结局
未报告次要终点