Hemodynamic Evaluation of Dose-response and Safety of Dry Powder Inhalation of Treprostinil
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|ClinicalTrials.gov Identifier: NCT03884465|
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : December 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension||Drug: Inhaled dry powder treprostinil (LIQ861)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||
Subjects will be enrolled in 4 sequential cohorts, each with an increasing initial dose of inhaled dry powder treprostinil (LIQ861) at 25μg, 50μg, 75μg, and 100μg capsule strengths (8 subjects at each dose level). Subjects will undergo right heart catheterization (RHC) at Day 1 to assess hemodynamic response.
Subjects enrolled in Germany will continue in a follow-up hemodynamic and long-term safety study beginning immediately after the conclusion of the post-RHC assessments on Day 1 of Part A. Subjects will continue on therapy at four times daily (QID) on Day 1 and until Week 16 and may be titrated up or down by no more than one 25 μg increment per week, based upon symptomatic relief or side effects experienced by the subject. Investigators may also initiate Part B dosing at 25 μg before following this titration schedule.
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||November 11, 2019|
|Estimated Primary Completion Date :||November 30, 2020|
|Estimated Study Completion Date :||July 5, 2021|
Experimental: Inhaled dry powder treprostinil (LIQ861)
Full study population receives inhaled dry powder treprostinil (LIQ861) at 25μg, 50μg, 75μg or 100μg capsule strengths.
Drug: Inhaled dry powder treprostinil (LIQ861)
Inhaled dry powder treprostinil (LIQ861) at 25μg, 50μg, 75μg, or 100μg capsule strengths. Single dose in the acute setting. QID in the chronic setting.
- Change in Pulmonary Vascular Resistance (PVR) [ Time Frame: 2 hours (120 minutes) post-dose on Day 1 and Week 16 ]Calculated in Wood units
- Change in Pulmonary Artery Pressure (PAP) [ Time Frame: 2 hours (120 minutes) post-dose on Day 1 and Week 16 ]Systolic, diastolic, and mean pressure measured in millimeters of mercury (mmHG)
- Change in Cardiac Output (CO) [ Time Frame: 2 hours (120 minutes) post-dose on Day 1 and Week 16 ]Measured in liters per minute (L/min)
- Change in Pulmonary Artery Oxygen Saturation (PAO2%) [ Time Frame: 2 hours (120 minutes) post-dose on Day 1 and Week 16 ]Measured as a percent oxyhemoglobin saturation
- Number of participants with treatment emergent adverse events (AEs) [ Time Frame: Baseline until the end of study, approximately 18 months (Mar-2021) ]Treatment-emergent adverse events and serious adverse events will be grouped by MedDRA System Organ Class, dose level at onset, time on drug at onset, and relationship to dose titration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884465
|Contact: Clinical Study Manager Clinical Operationsemail@example.com|
|CHRU de Nancy||Recruiting|
|Nancy, Vandoeuvre Les Nancy, France, 54500|
|Contact: Study Coordinator +330383153235 firstname.lastname@example.org|
|CHU de Bicetre||Recruiting|
|Le Kremlin-Bicêtre, France, 94270|
|Contact: Study Coordinator 33145217916 email@example.com|
|Studienambulanz fur Pulmonale Hypertonie at Medizinishe Klinik II, Universitatskinikum Giessen und Marburg GmbH||Recruiting|
|Gießen, Germany, 35392|
|Contact: Study Coordinator 496419942475 firstname.lastname@example.org|
|Principal Investigator:||Ardeschir Ghofrani, Prof. MD.||Universitatskinikum Giessen und Marburg GmbH|