Authorised Therapeutic confirmatory (Phase III) Fibrotic Lung Disease

Extension Study of Inhaled Treprostinil in Subjects with Fibrotic Lung Disease

EU CTIS ID: 2023-504471-25-00

What this study is testing

To evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with IPF or PPF.

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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.

You likely can't join if

  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Mexico
  • Israel
  • Argentina
  • Korea, Republic of
  • Taiwan
  • Canada
  • United States
  • Chile
  • New Zealand
  • Peru
  • Australia

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Mexico; Israel; Argentina; Korea, Republic of; Taiwan; Canada and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.