Hemodynamic Evaluation of Dose-response and Safety of Dry Powder Inhalation of Treprostinil (NCT03884465) | Clinical Trial Compass
TerminatedPhase 2
Hemodynamic Evaluation of Dose-response and Safety of Dry Powder Inhalation of Treprostinil
Stopped: COVID
France, Germany15 participantsStarted 2019-11-11
Plain-language summary
Acute and chronic hemodynamic dose-response and safety evaluation of LIQ861 in PAH subjects.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. An Institutional Review Board (IRB) approved informed consent is signed and dated by the subject prior to any study related activities.
✓. The subject is 18 years of age or older.
✓. If the subject is a female of childbearing potential, then the subject has a negative pregnancy test at the Day 1 Visit (tests performed within 2 days before Day 1 are accepted) and agrees to practice a highly effective (failure rate of less than 1% per year when used consistently and correctly) method of birth control until 24 hours after completion of all study assessments defined in Appendix 1. 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.
✓. The subject has been diagnosed with PAH belonging to one of the following subgroups of the updated Nice Clinical Classification Group 1, which includes:
✓. Idiopathic PAH (1.1), or
✓. Heritable PAH (1.2), or
✓. Drug and toxin induced PAH (1.3), or
✓. 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
Exclusion criteria
✕. 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.
What they're measuring
1
Change in Pulmonary Vascular Resistance (PVR)
Timeframe: 2 hours (120 minutes) post-dose on Day 1 and Week 16
2
Change in Pulmonary Artery Pressure (PAP)
Timeframe: 2 hours (120 minutes) post-dose on Day 1 and Week 16
3
Change in Cardiac Output (CO)
Timeframe: 2 hours (120 minutes) post-dose on Day 1 and Week 16
4
Change in Pulmonary Artery Oxygen Saturation (PAO2%)
Timeframe: 2 hours (120 minutes) post-dose on Day 1 and Week 16
. Subjects with pulmonary hypertension (PH) in the Updated Nice Classification Groups 2-5, or PAH Group 1 subgroups not covered by the inclusion criteria (e.g., associated with portal hypertension \[1.4.3\] or with schistosomiasis \[1.4.5\]).
✕. The subject is currently taking prostacyclin analogues or agonists, including treprostinil, iloprost, epoprostenol or selexipag.
✕. The subject has discontinued any medication (except for anticoagulants, but otherwise including but not limited to oxygen, a different class of vasodilator, diuretic, digoxin, and digitalis) for pulmonary hypertension within 14 days prior to Day 1.
✕. The subject has had a new type of 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.
✕. The subject has uncontrolled systemic hypertension as evidenced by systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg at the time of screening.
✕. 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 symptomatic coronary artery disease (CAD).