Pulmonary Arterial Hypertension Clinical Trial
— IMPAHCTOfficial title:
IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients With Pulmonary Arterial Hypertension (PAH)
IMPAHCT: Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial is a Phase 2b/Phase 3 study to evaluate the safety and efficacy of AV-101 (dry powder inhaled imatinib) in patients with Pulmonary Arterial Hypertension (PAH). The Phase 2b part of the study will assess three doses to establish an optimal dose for the Phase 3 part of the study. The Phase 2b primary endpoint will be the placebo corrected change in pulmonary vascular resistance (PVR). The Phase 3 primary endpoint will be the placebo corrected change in 6-minute walk distance (6MWD) after 24 weeks of treatment.
| Status | Recruiting |
| Enrollment | 462 |
| Est. completion date | January 2025 |
| Est. primary completion date | December 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | Key Inclusion Criteria - PAH belonging to one of the subgroups: 1. I/HPAH, PAH-CTD, 2. PAH due to drugs and/or toxins/chemicals (having been in the care of the investigator for at least one year with no relapses of drug or toxin/chemical abuse), 3. HIV associated or 4. PAH due to repaired congenital heart disease (at least 1 year since repair) - World Health Organization (WHO) Functional Class II, III or IV symptoms - Stable concomitant background therapy of at least two PAH approved medications - Able to walk a distance of at least 100 m but no more than 475 m during the Screening 6-minute walk tests. Key Exclusion Criteria - Pulmonary hypertension (PH) belonging to Groups 2 to 5 - A history of left-sided heart disease - Pregnant or breast-feeding females Additional criteria may apply, per protocol |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Hospital Britanico de Buenos Aires | Buenos Aires | |
| Argentina | Nexo Salud Investigación Clínica | Buenos Aires | |
| Argentina | Sanatorio de la Trinidad Mitre | Buenos Aires | |
| Argentina | Cardiología Palermo | Caba | |
| Argentina | Hospital Italiano de Cordoba | Córdoba | |
| Argentina | Insituto Medico DAMIC | Córdoba | |
| Argentina | Hospital Dr. Jose Maria Cullen | Santa Fe | |
| Australia | Royal Adelaide Hospital | Adelaide | |
| Australia | Sunshine Coast University Hospital | Birtinya | Queensland |
| Australia | Royal Prince Alfred Hospital | Camperdown | New South Wales |
| Australia | The Prince Charles Hospital | Chermside | Queensland |
| Australia | Concord Repatriation General Hospital | Concord West | New South Wales |
| Australia | Nepean Hospital | Kingswood | New South Wales |
| Australia | The Alfred Hospital | Melbourne | Victoria |
| Australia | Fiona Stanley Hospital | Murdoch | |
| Australia | Westmead Hospital | Westmead | New South Wales |
| Austria | AKH - Medizinische Universitat Wien | Vienna | |
| Belgium | Hopital Erasme - Cliniques Universitaires de Bruxelles | Brussels | |
| Belgium | UZ Leuven | Leuven | |
| Brazil | Santa Casa de Misericordia de Porto Alegre | Porto Alegre | |
| Canada | The Governors of the University of Calgary | Calgary | Alberta |
| Canada | University of Alberta Hospital | Edmonton | Alberta |
| Canada | London Health Science Centre | London | Ontario |
| Canada | Jewish General Hospital | Montréal | Quebec |
| Chile | Centro de Investigaciones Clinicas de la Universidad Catolica | Santiago | |
| China | Peking Union Medical College Hospital | Beijing | |
| China | Chongqing Medical University - The First Affiliated Hospital | Chongqing | |
| China | Guangdong Provincial People's Hospital | Guangdong | |
| China | Central South University - The Second Xiangya Hospital | Hunan | |
| China | Yanan Hospital of Kunming City | Kunming | |
| China | Gansu Provincial People's Hospital | Lanzhou | |
| China | Southeast University (SEU) - Zhongda Hospital | Nanjing | |
| China | Shanghai Pulmonary Hospital | Shanghai | |
| China | Tianjin Medical University General Hospital | Tianjin | |
| Czechia | Vseobecna fakultni nemocnice v Praze | Praha | |
| France | Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel | Bron | |
| France | Groupement Hospitalier Sud - Hôpital Bicêtre | Le Kremlin-Bicêtre | Cedex |
| France | Hôpital Nord - CHU Marseille | Marseille | |
| France | Hopital Arnaud de Villeneuve | Montpellier | |
| France | Les Hôpitaux Universitaires de Strasbourg | Strasbourg | |
| Germany | Universitaetsklinikum Carl Gustav Carus TU Dresden | Dresden | |
| Germany | Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen | Giesen | |
| Germany | Universitaetsklinikum Heidelberg | Heidelberg | |
| Germany | München Klinik Bogenhausen | München | |
| Greece | University General Hospital Attikon | Athens | |
| Greece | Cardiosurgery Hospital | Kallithéa | |
| Greece | AHEPA General Hospital of Thessaloniki | Thessaloníki | |
| Israel | The Lady Davis Carmel Medical Center | Haifa | |
| Israel | Hadassah University Hospital - Ein Kerem | Jerusalem | |
| Israel | Tel Aviv Sourasky Medical Center | Tel Aviv | |
| Italy | Azienda Ospedaliero Universitaria Ospedali Riuniti - Foggia | Foggia | |
| Italy | Ospedale San Giuseppe - Fatebenefratelli | Milan | |
| Italy | Azienda Socio Sanitaria Territoriale di Monza | Monza | |
| Italy | Azienda Ospedaliera Vincenzo Monaldi | Napoli | |
| Italy | Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione | Palermo | |
| Italy | Fondazione IRCCS Policlinico San Matteo | Pavia | |
| Italy | Azienda Ospedaliera Universitaria Policlinico Umberto I | Rome | |
| Latvia | Pauls Stradins Clinical University Hospital | Riga | |
| Mexico | CICUM San Miguel | Guadalajara | Jalisco |
| Mexico | Instituto Nacional de Cardiologia Dr Ignacio Chavez Rivera | Mexico City | |
| Mexico | Unidad de Investigacion Clinica en Medicina S.C. | Monterrey | Nuevo León |
| Mexico | Universidad Autonoma de Nuevo Leon, Hospital Universitario | Monterrey | |
| Netherlands | Amsterdam UMC, Locatie VUMC | Amsterdam | |
| Poland | Krakowski Szpital Specjalistyczny im. Jana Pawla II | Krakow | |
| Poland | Bieganski Provincial Specialist Hospital | Lódz | |
| Poland | Szpital Kliniczny Przemienienia Panskiego UM im. Marcinkowskiego | Poznan | |
| Poland | Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego | Wroclaw | |
| Portugal | Hospital Garcia de Orta, EPE | Almada | |
| Portugal | Hospital Pulido Valente | Lisboa | |
| Portugal | CHUPorto | Porto | |
| Puerto Rico | Cardiopulmonary Research Center | Guaynabo | |
| Singapore | National University Hospital | Singapore | |
| Singapore | Tan Tock Seng Hospital | Singapore | |
| South Africa | Center of Chest Disease Johannesburg | Johannesburg | |
| Spain | Hospital Clinic de Barcelona | Barcelona | |
| Spain | Hospital Universitari Vall d'Hebron | Barcelona | |
| Spain | Hosp. Universitario Gran Canaria Doctor Negrin | Las Palmas de Gran Canaria | |
| Spain | Hospital 12 de Octubre | Madrid | |
| Spain | Universidad Autonoma de Madrid | Madrid | |
| Spain | Hospital Universitario Virgen de la Victoria | Málaga | |
| Spain | Hospital universtario de Salamanca | Salamanca | |
| Spain | Hosp. Universitario Marques de Valdecilla | Santander | |
| Spain | Hospital Universitario de Toledo | Toledo | |
| Sweden | Norrlands Universitetssjukhus | Umeå | |
| United Kingdom | Golden Jubilee National Hospital | Glasgow | |
| United Kingdom | Imperial College Healthcare NHS Trust | London | England |
| United Kingdom | Royal Brompton Hospital | London | |
| United Kingdom | The Newcastle upon Tyne Hospitals NHS Foundation Trust | Newcastle | |
| United States | The Unviersity of New Mexico - UNM Hospitals | Albuquerque | New Mexico |
| United States | University of Michigan | Ann Arbor | Michigan |
| United States | Emory University | Atlanta | Georgia |
| United States | University of Colorado Denver | Aurora | Colorado |
| United States | Tufts Medical Center, Inc. | Boston | Massachusetts |
| United States | New York-Presbyterian Brooklyn Methodist Hospital | Brooklyn | New York |
| United States | The Lindner Center for Research and Education | Cincinnati | Ohio |
| United States | University of Cincinnati | Cincinnati | Ohio |
| United States | The Ohio State University Wexner Medical Center | Columbus | Ohio |
| United States | Baylor University Medical Center | Dallas | Texas |
| United States | National Jewish Health | Denver | Colorado |
| United States | Duke University Medical Center - Duke South Clinic | Durham | North Carolina |
| United States | Inova Heart and Vascular Institute | Falls Church | Virginia |
| United States | Houston Methodist Hospital | Houston | Texas |
| United States | Indiana University Health | Indianapolis | Indiana |
| United States | University of Iowa Hospitals & Clinics | Iowa City | Iowa |
| United States | Mayo Clinic Florida | Jacksonville | Florida |
| United States | University of Kansas Medical Center | Kansas City | Kansas |
| United States | Stat Care Pulmonary Consultants, PLLC | Knoxville | Tennessee |
| United States | Cedars-Sinai Medical Center, Pulmonary & Critical Care | Los Angeles | California |
| United States | Dept of Veterans Affairs Greater Los Angeles Healthcare System | Los Angeles | California |
| United States | Kaiser Permanente Los Angeles Medical Center | Los Angeles | California |
| United States | UCLA/David Geffen School of Medicine-Pulmonary and Criticial Care | Los Angeles | California |
| United States | University of Minnesota | Minneapolis | Minnesota |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | NYU Langone Seaport | New York | New York |
| United States | Sentara Medical Group - Sentara Pulmonary & Critical Care Specialists | Norfolk | Virginia |
| United States | University of Nebraska Medical Center- Hematology/Oncology Section | Omaha | Nebraska |
| United States | Orlando Heart Center | Orlando | Florida |
| United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
| United States | Arizona Pulmonary Specialists, Ltd. | Phoenix | Arizona |
| United States | UPMC Presbyterian Hospital | Pittsburgh | Pennsylvania |
| United States | UC Davis Medical Center | Sacramento | California |
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| United States | University of California | San Francisco | California |
| United States | Louisiana State University health Sciences Center | Shreveport | Louisiana |
| United States | LA Biomedical Research Institute Harbor | Torrance | California |
| United States | University of Arizona, Department of Medicine | Tucson | Arizona |
| United States | George Washington University Medical Faculty Associates, Inc. | Washington | District of Columbia |
| United States | Georgetown University Hospital | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Aerovate Therapeutics |
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, France, Germany, Greece, Israel, Italy, Latvia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Singapore, South Africa, Spain, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Phase 2b: Change from Baseline in Pulmonary Vascular Resistance (PVR) | 24 weeks | ||
| Primary | Phase 3: Change from Baseline in Six Minute Walk Distance (6MWD) | 24 weeks | ||
| Secondary | Phase 2b: Change from Baseline in N-terminal pro B-type natriuretic peptide (NT-proBNP) | 24 weeks | ||
| Secondary | Phase 2b: Change from Baseline in Six Minute Walk Distance (6MWD) | 24 weeks | ||
| Secondary | Phase 2b: Incidence of Clinical Worsening | 24 weeks | ||
| Secondary | Phase 2b: Proportion of Subjects with Improvement in WHO Functional Class | 24 weeks | ||
| Secondary | Phase 2b: Change from Baseline in Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2.0 Risk Score | REVEAL Lite 2.0 risk scores range from 1 to 14; a higher score represents higher risk | 24 weeks | |
| Secondary | Phase 2b: Change from Baseline in Health-Related Quality of Life emPHasis-10 Questionnaire Score | emPHasis-10 questionnaire scores range from 0 - 50; a higher score represents a higher symptom burden | 24 weeks | |
| Secondary | Phase 3: Change from Baseline in NT-proBNP | 24 weeks | ||
| Secondary | Phase 3: Time to Clinical Worsening | 24 weeks | ||
| Secondary | Phase 3: Proportion of Subjects with Improvement in WHO Functional Class | 24 weeks | ||
| Secondary | Phase 3: Change from Baseline in Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2.0 Risk Score | REVEAL Lite 2.0 risk scores range from 1 to 14; a higher score represents higher risk | 24 weeks | |
| Secondary | Phase 3: Change from Baseline in Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Questionnaire Score | PAH-SYMPACT is a patient reported outcome instrument developed to assess PAH symptoms and impacts | 24 weeks |
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