Hemodynamic Evaluation of Dose-response and Safety of Dry Powder Inhalation of Treprostinil
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pulmonary Arterial Hypertension
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Sequential AssignmentIntervention Model Description: Subjects will be enrolled in 4 sequential cohorts, each with an increasing initial dose of inhaled dry powder treprostinil (LIQ861) at 25?g, 50?g, 75?g, and 100?g 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 ?g increment per week, based upon symptomatic relief or side effects experienced by the subject. Investigators may also initiate Part B dosing at 25 ?g before following this titration schedule.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Data will be collected on acute and chronic hemodynamic response to inhaled dry powder treprostinil (LIQ861) via right-heart catheterization. Study subjects will contribute to the overall safety profile of LIQ861.
Data will be collected on acute and chronic hemodynamic response to inhaled dry powder treprostinil (LIQ861) via right-heart catheterization. Study subjects will contribute to the overall safety profile of LIQ861.
Tracking Information
- NCT #
- NCT03884465
- Collaborators
- FGK Clinical Research GmbH
- Investigators
- Principal Investigator: Ardeschir Ghofrani, Prof. MD. Universitatskinikum Giessen und Marburg GmbH
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