Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using Tyvaso
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 45
Summary
- Conditions
- Pulmonary Arterial Hypertension
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Single-sequence in which subjects on a stable regimen of Tyvaso will switch to a corresponding dose of TreTMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
United Therapeutics Corporation (UTC) is developing a combination drug-device product which is comprised of a dry powder formulation of Treprostinil Inhalation Powder (TreT) and a small, portable, dry powder inhaler. In this Phase 1b safety and tolerability study, patients with PAH on a stable dose ...
United Therapeutics Corporation (UTC) is developing a combination drug-device product which is comprised of a dry powder formulation of Treprostinil Inhalation Powder (TreT) and a small, portable, dry powder inhaler. In this Phase 1b safety and tolerability study, patients with PAH on a stable dose of Tyvaso (6 to 12 breaths 4 times daily [QID]) will be evaluated after switching to a corresponding dose of TreT. Patients will undergo PK assessments, safety assessments, a 6-Minute Walk Test (6MWT), and questionnaires for satisfaction/preference for inhaled devices and patient-reported PAH symptoms and impact. Following 3 weeks of treatment with TreT, patients will be offered the opportunity to participate in the Optional Extension Phase until the study terminates or the drug/device becomes commercially available.
Tracking Information
- NCT #
- NCT03950739
- Collaborators
- Not Provided
- Investigators
- Not Provided
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