An Open-label Extension Study of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis - RIN-PF-302

nited Therapeutics Corp.0 个研究点目标入组 16 人开始时间: 待定最近更新: 2024年4月9日

试验速览

暂无简介。

•1. Subject gives voluntary informed consent to participate in the study.
•2. The subject participated in RIN-PF-301 or RIN-PF-303 and had 1 of the
•a. Remained on study drug and completed all scheduled study visits
•b. Was enrolled in RIN-PF-301 or RIN-PF-303 at the time that the study or study
•subject was discontinued by the Sponsor.
•3. Women of childbearing potential must be non-pregnant (as confirmed by a
•pregnancy test at OLE Entry Visit and Baseline) and non-lactating, and will do
•a. Abstain from intercourse (when it is in line with their preferred and usual
•b. Use 2 medically acceptable, highly effective forms of contraception for the
•of the study, and at least 30 days after discontinuing study drug. Medically
•acceptable, highly effective forms of contraception can include approved
•contraceptives (oral, injectable, and implantable) and barrier methods (such as
•condom or diaphragm) when used with a spermicide.
•Women who are successfully sterilized or postmenopausal are not considered to
•reproductive potential.
•4. Males with a partner of childbearing potential must use a condom for the
•duration of
•treatment and for at least 48 hours after discontinuing study drug.
•5. 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.

•1. Subject is pregnant or lactating.
•2. In the opinion of the Investigator, enrollment in RIN-PF-302 would represent
•a risk to the
•subject*s overall health.

发起方

nited Therapeutics Corp.