EUCTR2022-001951-18-DK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
适应症
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 Participants who experienced any hypersensitivity or adverse drug reaction or were withdrawn early/discontinued in a previous PAH TPIP study, which, in the opinion of the Investigator, could indicate that continued treatment with TPIP may present an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
- •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,
- •18. Participants who currently inhale marijuana (re
研究者
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