Estudio de extensión abierto para evaluar la seguridad, la tolerabilidad y la efectividad del uso a largo plazo de treprostinil palmitil en polvo para inhalación en participantes con hipertensión arterial pulmonar

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05649748Tipo: INTERVENTIONALInicio: 7 de mar de 2023Fin estimado: 31 de dic de 2026

Resumen

El propósito principal del estudio es evaluar la seguridad y la tolerabilidad del uso a largo plazo de TPIP en participantes con HAP procedentes de los estudios INS1009-201 (NCT04791514), INS1009-202 (NCT05147805) y otros estudios antecedentes de TPIP en participantes con HAP.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Male and female participants who completed end of treatment study visit in Study INS1009-201, INS1009-202, or any other lead-in PAH TPIP study. 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 INS1009-201, INS1009-202, or any other lead-in PAH TPIP study.

Criterios de exclusión

Initiation of parenteral administration of prostacyclin analogues (eg, TRE, epoprostenol) since the completion of studies INS1009-201, INS1009-202 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.
Any new ventricular or supraventricular tachyarrhythmia except for paroxysmal atrial fibrillation and any new symptomatic bradycardia.
New-onset of heart disease including left ventricular ejection fraction (LVEF) ≤40% or clinically significant valvular, constrictive, or symptomatic atherosclerotic heart disease (eg, stable angina, myocardial infarction, etc).
New evidence of thromboembolic disease as assessed by ventilation/perfusion (VQ) scan, pulmonary angiography, or pulmonary computed tomography (CT) scan.
Active and current symptomatic coronavirus disease 2019 (COVID-19) or previous severe disease and/or hospitalization due to COVID-19.
Interval organ transplantation.
New active liver disease or hepatic dysfunction.
Interval malignancy with exception of completely treated in situ carcinoma of the cervix and completely treated non-metastatic squamous or basal cell carcinoma of the skin.
Use of any investigational drug/device or participation in any investigational study within 30 days prior to screening, not including TPIP of the lead-in study.
Current use of cigarettes (as defined by Centers for Disease Control and Prevention \[CDC\]) or e-cigarettes: An adult who has smoked at least 100 cigarettes in his or her lifetime, who smokes either every day or some days.
Participants who currently inhale marijuana (recreational or medical).

Intervenciones

drug

Treprostinil Palmitil

Administered by oral inhalation, using a Plastiape capsule-based dry powder inhaler.

drug

Placebo

Administered by oral inhalation using a Plastiape capsule-based dry powder inhaler

Ubicaciones

ARG009

Quilmes, Buenos Aires, Argentina

ARG006

Rosario, Santa Fe Province, Argentina

ARG007

San Miguel de Tucumán, Tucumán Province, Argentina

ARG004

Córdoba, Argentina

ARG001

Córdoba, Argentina

Patrocinadores

PrincipalInsmed Incorporated

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