CTIS2023-504471-25-00招募中1 期
An Open-label Extension Study of Inhaled Treprostinil in Subjects with Fibrotic Lung Disease - RIN-PF-302
nited Therapeutics Corp.0 个研究点目标入组 1,850 人开始时间: 2023年6月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,850
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Subject gives voluntary informed consent to participate in the study., The subject participated in RIN-PF-301, RIN-PF-303 or RIN-PF-305 and had 1 of the following applied: a. Remained on study drug and completed all scheduled study visits b. Was enrolled in RIN-PF-301, RIN-PF-303 or RIN-PF-305 at the time that the study or study subject was discontinued by the Sponsor for reasons other than safety., Women of childbearing potential must be non-pregnant (as confirmed by a urine pregnancy test at OLE Entry Visit) and non-lactating, and will agree to do 1 of the following: a. Abstain from intercourse (when it is in line with their preferred and usual lifestyle) b. Use 2 medically acceptable, highly effective forms of contraception for the duration of the study, and at least 30 days after discontinuing study drug. Medically acceptable, highly effective forms of contraception can include approved hormonal contraceptives (oral, injectable, and implantable) and barrier methods (such as a condom or diaphragm) when used with a spermicide. Women who are successfully sterilized or postmenopausal are not considered to be of reproductive potential., Males with a partner of childbearing potential must agree to use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug., In the opinion of the Investigator, the subject is able to communicate effectively with study personnel, and is considered reliable, willing, and likely to be cooperative with protocol requirements, including attending all study visits.
排除标准
- •Subject is pregnant or lactating., In the opinion of the Investigator, enrollment in RIN-PF-302 would represent a risk to the subject’s overall health., Use of any other investigational drug/device or participation in any investigational study in which the subject received a medical intervention (ie, procedure, device, medication/supplement). Subjects participating in non-interventional, observational, or registry studies are eligible.
研究者
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