2023-505540-19-00招募中3 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 Hypertension Associated with Interstitial Lung Disease
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Insmed Inc.
- 入组人数
- 27
- 试验地点
- 17
- 主要终点
- Frequency and severity of TEAEs during the study.
研究概览
简要总结
To evaluate the safety and tolerability of the long-term use of TPIP in participants with PH-ILD from Study INS1009-211 and other lead-in studies of TPIP in participants with PH-ILD (pulmonary hypertension associated with interstitial lung disease).
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 主要目的
- Treatment Period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Male and female participants who completed the end of treatment visit in Study INS1009-211, or any other lead-in PH-ILD 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 INS1009-211, or any other lead-in PH-ILD TPIP study. Requirements for baseline screening assessments are located in Section 4.1.1.
- •of the Protocol
- •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.
排除标准
- •Participants who experienced any hypersensitivity or adverse drug reaction or were withdrawn early/discontinued in a previous PH-ILD TPIP study, which in the opinion of the Investigator, could indicate that continued treatment with TPIP may present an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 (contraceptive guidance is located in Section 10.4). Female participants of childbearing potential must have a negative urine pregnancy test result at trial entry before the first dose of study drug. Additional requirements for pregnancy testing during and after study intervention are located in Section 8.2.4.2 and Section 8.3.
- •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.
结局指标
主要结局
Frequency and severity of TEAEs during the study.
Frequency and severity of TEAEs during the study.
次要结局
- Change from pre-OLE baseline* to Month 6, Month 12, Month 18, and Month 24 in 6MWD (absolute and relative).
- Change from pre-OLE baseline* to Month 6, Month 12, Month 18, and Month 24 in FVC, FVC%, FEV1, FEV1%, and FEF25-75% (absolute and relative).
- Change from pre-OLE baseline* to Month 6, Month 12, Month 18, and Month 24 in the concentration of NT-proBNP in blood.
- Change from pre-OLE baseline* to Month 12 and Month 24 in DLCO (absolute and relative).
- Annualized rate of clinical worsening events. Clinical worsening is defined as one of the following: ---Hospitalization due to a cardiopulmonary indication ---Lung transplantation ---Death from any cause ---Decrease in 6MWD ≥ 15% from baseline, directly related to disease under study, at 2 consecutive visits at least 24 hours apart ---Need for additional PH therapy.
- Annualized clinical worsening event rate defined as the total number of clinical worsening events that occurred during the treatment period divided by the total number of participant-years during the treatment period.
- Annualized rate of occurrence of AE-ILDs.
- Change from OLE baseline in the K-BILD and EQ-5D-5L questionnaire scores at Month 6, Month 12, Month 18, and Month 24.
- Plasma concentration levels of TP and TRE.
研究者
Natasha Makulova
Scientific
Insmed Inc.
研究点 (17)
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