Estudio de extensión abierto para evaluar la seguridad, tolerabilidad y efectividad del uso prolongado de treprostinil palmitil en polvo para inhalación en participantes con hipertensión pulmonar asociada a enfermedad pulmonar intersticial

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05649722Tipo: INTERVENTIONALInicio: 11 de may de 2023Fin estimado: 14 de mar de 2026

Resumen

El objetivo primario de este estudio es evaluar la seguridad y tolerabilidad del uso prolongado de TPIP en participantes con HP-EPI provenientes del estudio INS1009-211 (NCT05176951) y otros estudios predecesor de TPIP en participantes con HP-EPI.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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 of their completion of the lead-in study are eligible for enrolment within one year of their lead-in end of treatment visit.
Complete baseline screening assessments to confirm eligibility to participate if more than 30 days have elapsed since the end of the study visit in Study INS1009-211, or any other lead-in PH-ILD TPIP study.
Capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Criterios de exclusión

Participants who experienced any hypersensitivity or adverse drug reaction or were withdrawn early/discontinued in a previous PH-ILD TPIP study, which in the opinion of the Investigator, could indicate that continued treatment with TPIP may present an 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 oral prostacyclin 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 abnormalities at screening that, in the opinion of the Investigator, suggest a new and/or insufficiently understood disease that may present an unreasonable risk to the study participant as a result of participation in the study.

Intervenciones

drug

Treprostinil Palmitil Inhalation Powder

Oral inhalation using a capsule-based dry powder inhaler device.

drug

Placebo

Oral placebo inhalation using a capsule-based dry powder inhaler device.

Ubicaciones

ARG003

Autonomus City of Buenos Aires, Buenos Aires, Argentina

ARG001

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalInsmed Incorporated

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