A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH)
- Conditions
- Pulmonary Arterial Hypertension
- Registration Number
- NCT05036135
- Lead Sponsor
- Aerovate Therapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated
- Sex
- All
- Target Recruitment
- Not specified
Key Inclusion Criteria<br><br> - PAH belonging to one of the subgroups:<br><br> 1. I/HPAH, PAH-CTD,<br><br> 2. PAH due to drugs and/or toxins/chemicals (having been in the care of the<br> investigator for at least one year with no relapses of drug or toxin/chemical<br> abuse),<br><br> 3. HIV associated or<br><br> 4. PAH due to repaired congenital heart disease (at least 1 year since repair)<br><br> - World Health Organization (WHO) Functional Class II, III or IV symptoms<br><br> - Stable concomitant background therapy of at least one PAH approved medications<br><br> - Able to walk a distance of at least 100 m but no more than 475 m during the<br> Screening 6-minute walk tests.<br><br>Key Exclusion Criteria<br><br> - Pulmonary hypertension (PH) belonging to Groups 2 to 5<br><br> - A history of left-sided heart disease<br><br> - Pregnant or breast-feeding females<br><br>Additional criteria may apply, per protocol
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase 2b: Change from Baseline in Pulmonary Vascular Resistance (PVR);Phase 3: Change from Baseline in Six Minute Walk Distance (6MWD)
- Secondary Outcome Measures
Name Time Method Phase 2b: Change from Baseline in N-terminal pro B-type natriuretic peptide (NT-proBNP);Phase 2b: Change from Baseline in Six Minute Walk Distance (6MWD);Phase 2b: Time to Clinical Worsening;Phase 2b: Proportion of Subjects with Improvement in WHO Functional Class;Phase 2b: Change from Baseline in Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2.0 Risk Score;Phase 2b: Change from Baseline in Health-Related Quality of Life emPHasis-10 Questionnaire Score;Phase 3: Change from Baseline in NT-proBNP;Phase 3: Time to Clinical Worsening;Phase 3: Proportion of Subjects with Improvement in WHO Functional Class;Phase 3: Change from Baseline in Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2.0 Risk Score;Phase 3: Change from Baseline in Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Questionnaire Score