EUCTR2022-001951-18-AT招募中1 期
An Open-Label Extension Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term use of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Arterial Hypertension
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 99
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Participants who completed the end of treatment visit in Study INS1009-201, Study 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.
- •2. 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, Study INS1009-202, or any other lead-in PAH TPIP in study.
- •3. Capable of giving signed informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •1. Participants who experienced any hypersensitivity or adverse drug reaction or were withdrawn early/discontinued in a previous PAH TPIP study, which, in the opinion of the Investigator, could indicate that continued treatment with TPIP may present an unreasonable risk for the participant.
- •2. 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.
- •3. Pregnant or breastfeeding.
- •4. 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.
- •5. QTcF interval > 480 ms on resting ECG at screening, not including participants with right bundle branch block (RBBB) leading to a prolongation of the QRS.
- •6. Any new ventricular or supraventricular tachyarrhythmia except for paroxysmal atrial fibrillation and any new symptomatic bradycardia.
- •7. 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).
- •8. New evidence of thromboembolic disease as assessed by VQ scan, pulmonary angiography, or pulmonary CT scan.
- •9. Deterioration in renal function to estimated glomerular filtration rate < 30 mL/min/1.73 m2
- •10. New active liver disease or hepatic dysfunction manifested as:
- •Elevated liver function test results (ALT or AST > 2 × ULN) and/or
- •Bilirubin > 1.5 × ULN (isolated bilirubin > 1.5 × ULN; ULN is acceptable
- •if bilirubin is fractionated and direct bilirubin < 35%)
- •11. Active and current symptomatic COVID-19 or previous severe disease and/or hospitalization due to COVID-19 (Section 10.1.3.1.3).
- •12. History of abnormal bleeding or bruising with a platelet count of < 50,000/µL at screening.
- •13. Interval organ transplantation.
- •14. Any clinically significant abnormal laboratory values at screening or diseases or disorders (eg, cardiovascular, pulmonary, gastrointestinal,
- •liver, kidney, neurological, musculoskeletal, endocrine, metabolic, psychiatric, physical impairment) that, in the opinion of the Investigator, may put the participant at risk by participating in the study, or interfere with the participant's treatment, assessment, or influence the results of
- •the study, or have compliance issues with the study or have a planned or anticipated major surgical procedure during the study.
- •15. 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.
- •16. 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.
- •17. Current use of cigarettes (as defined by 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 (Glossary, CDC Tobacco Glossary, 2017).
- •18. Participant who currently inhale marijuana (recr
研究者
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