EUCTR2018-003414-40-FR进行中（未招募）1 期
A Two Part, Phase 2 Open-label, Multi-Centre, Dose Escalation Hemodynamic Study to Evaluate Dose-Response and Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Subjects
iquidia Technologies, Inc.0 个研究点目标入组 32 人开始时间: 2018年11月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. An Institutional Review Board (IRB) approved informed consent is signed and dated by the subject prior to any study-related activities.
- •2. The subject is 18 years of age or older.
- •3. If the subject is a female of childbearing potential, then the subject has a negative pregnancy test at the Day 1 Visit and agrees to practice a highly effective (failure rate of less than 1% per year when used consistently and correctly) method of birth control throughout the duration of the study. If the subject is postmenopausal or has documented surgical sterilization, a pregnancy test and birth control is not necessary. It is the Investigator’s responsibility for determining whether the subject has adequate birth control for study participation.
- •4. The subject has been diagnosed with Pulmonary Arterial Hypertension (PAH) belonging to one of the following subgroups of the updated Nice Clinical Classification Group 1, which includes:
- •a. Idiopathic PAH (1.1), or
- •b. Heritable PAH (1.2), or
- •c. Drug and toxin induced PAH (1.3), or
- •d. PAH associated with connective tissue disease (1.4.1), HIV infection (1.4.2), or congenital heart disease (1.4.4) with simple systemic-to-pulmonary shunt at least 1 year after surgical repair
- •5. The subject is NYHA Functional Class II - IV at Screening and:
- •a. has not previously been treated for PAH, or
- •b. has documented stable doses of no more than 2 approved non-prostacyclin therapies for at least 3 months prior to screening and is willing and able to add LIQ861 to their treatment regimen.
- •6. The subject can complete a baseline six-minute walk distance (6MWD) = 150 m.
- •7. The subject has had evidence of Forced Expiratory Volume in 1 Second (FEV1) = 60% and FEV1/ Forced Vital Capacity (FVC) ratio = 60% during the 6-month period prior to 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 19
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 13
排除标准
- •1. The subject's clinical condition is such that, in the opinion of the Investigator, they are not expected to remain clinically stable for the duration of the study.
- •2. Subjects with pulmonary hypertension (PH) in the Updated Nice Classification Groups 2-5, or Pulmonary Arterial Hypertension (PAH) Group 1 subgroups not covered by the inclusion criteria (e.g., associated with portal hypertension or with schistosomiasis)
- •3. The subject is currently taking prostacyclin analogues or agonists, including treprostinil, iloprost, and selexipag
- •4. The subject has had any PAH medication (except for anticoagulants) discontinued within 14 days prior to Day 1.
- •5. The subject has had a new type of chronic therapy (including but not limited to oxygen, a different class of vasodilator, diuretic, digoxin, and digitalis) for pulmonary hypertension added within 30 days prior to Day 1.
- •6. The subject has uncontrolled systemic hypertension as evidenced by persistent systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg.
- •7. The subject has a history of hemodynamically significant left-sided heart disease including, but not limited to: aortic or mitral valve disease, pericardial constriction, restrictive or congestive cardiomyopathy, or coronary artery disease (CAD).
- •8. The subject has had an atrial septostomy.
- •9. The subject has any serious or life-threatening disease other than conditions associated with PAH.
- •10. The subject is taking any excluded medications listed in the Investigator’s Brochure, namely inhibitors and inducers of CYP2C8 (See Appendix 3 in the Protocol).
- •11. The subject has a hypersensitivity or allergy to any of the ingredients of LIQ861, NO, or other clinically relevant allergies (clinical relevance per Investigator judgment).
- •12. The subject has had a pulmonary infarction (defined as infarction in more than one lung segment documented by V/Q scan or pulmonary angiography) within two weeks of Screening.
- •13. The subject has had a stroke or transient ischemic attack (TIA) within six months of Screening.
- •14. The subject has evidence of an active uncontrolled sepsis or systemic infection during Screening.
- •15. The subject is pregnant or lactating.
- •16. The subject has any musculoskeletal disease or any other disease that would limit ambulation.
- •17. The subject has participated in an investigational product or device study within the 30 days prior to Screening.
- •18. The subject has current evidence of drug abuse in the opinion of the Investigator.
- •19. The subject has severe hepatic impairment as evidenced by any history of ascites AND encephalopathy.
- •20. The subject has severe renal impairment (estimated glomerular filtration rate [eGFR] < 35).
- •21. The subject is an employee or an immediate family member to an employee of the sponsor or the Investigator.
- •22. The subject is not a member or beneficiary of a social security scheme.
- •23. The subject is not subject to a legal protection measure.
- •24. The subject has not been deprived of their liberty by a judicial or administrative decision.
- •25. The subject has a known Hepatitis B, Hepatitis C, or HIV infection.
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