Phase
Condition
Stress
Scleroderma
Pulmonary Arterial Hypertension
Treatment
Treprostinil Palmitil Inhalation Powder
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants who completed the end of treatment visit in Study INS1009-211 (NCT05176951). Participants for whom the OLE study was not available at the time oftheir completion of the lead-in study are eligible for enrolment within one year oftheir lead-in end of treatment visit.
Complete baseline screening assessments to confirm eligibility to participate ifmore than 30 days have elapsed since the end of the study visit in StudyINS1009-211, or any other lead-in PH-ILD TPIP study.
Capable of giving signed informed consent that includes compliance with therequirements and restrictions listed in the informed consent form (ICF) and in thisprotocol.
Exclusion
Exclusion Criteria:
Participants who experienced any hypersensitivity or adverse drug reaction or werewithdrawn early/discontinued in a previous PH-ILD TPIP study, which in the opinionof the Investigator, could indicate that continued treatment with TPIP may presentan unreasonable risk for the participant.
Initiation of parenteral administration of prostacyclin analogues (eg, TRE,epoprostenol) since the completion of Study INS1009-211 or other TPIP studies.Initiation of inhaled prostacyclin analogues (eg, TRE [Tyvaso] or iloprost) and oralprostacyclin analogues (eg, TRE [Orenitram]) or receptor agonists (eg, selexipag)are permitted if stopped 24 hours prior to the start of study drug administration.
Pregnant or breastfeeding. Male and female participants must use contraceptives that are consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participants of childbearing potential must have a negative urine pregnancy test result at trial entry before the first dose of study drug.
- Any medical or psychological condition, including relevant laboratory abnormalitiesat screening that, in the opinion of the Investigator, suggest a new and/orinsufficiently understood disease that may present an unreasonable risk to the studyparticipant as a result of participation in the study.
Study Design
Connect with a study center
ARG003
Autonomus City Of Buenos Aires, Buenos Aires C1280AEB
ArgentinaSite Not Available
ARG001
Rosario, Santa Fe S2013KDS
ArgentinaSite Not Available
AUS005
Macquarie Park, New South Wales 2109
AustraliaSite Not Available
BEL002
Liège, 4000
BelgiumSite Not Available
GER006
Heidelberg, Baden-Württemberg 69126
GermanySite Not Available
GER004
München, Bayern 81377
GermanySite Not Available
GER010
Gießen, Hessen 35392
GermanySite Not Available
GER003
Essen, Nordrhein-Westfalen 45239
GermanySite Not Available
GER001
Dresden, Sachsen 01307
GermanySite Not Available
GER002
Berlin, 13125
GermanySite Not Available
GER012
Berlin, 14050
GermanySite Not Available
ITA004
Milan, Lombardia 20123
ItalySite Not Available
ITA002
Monza, Lombardia 20900
ItalySite Not Available
ITA001
Palermo, Sicilia 90127
ItalySite Not Available
ITA003
Napoli, 80131
ItalySite Not Available
ESP007
Oviedo, Asturias 33011
SpainSite Not Available
ESP009
Santiago de Compostela, Galicia 15706
SpainSite Not Available
ESP003
Palma, Islas Baleares 07120
SpainSite Not Available
ESP005
Barcelona, 08907
SpainSite Not Available
ESP010
Barcelona, 8035
SpainSite Not Available
GBR003
Clydebank, Glasgow G81 4DY
United KingdomSite Not Available
GBR001
Sheffield, South Yorkshire S10 2JF
United KingdomSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.