A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH)
NCT ID: NCT05036135
Last Updated: 2024-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
202 participants
INTERVENTIONAL
2021-12-02
2024-08-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AV-101 10 mg
AV-101
AV-101 (imatinib) administered via dry powder inhalation
AV-101 35 mg
AV-101
AV-101 (imatinib) administered via dry powder inhalation
AV-101 70 mg
AV-101
AV-101 (imatinib) administered via dry powder inhalation
Placebo
Placebo
Placebo administered via dry powder inhalation
Interventions
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AV-101
AV-101 (imatinib) administered via dry powder inhalation
Placebo
Placebo administered via dry powder inhalation
Eligibility Criteria
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Inclusion Criteria
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 one 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.
Exclusion Criteria
* A history of left-sided heart disease
* Pregnant or breast-feeding females
Additional criteria may apply, per protocol
18 Years
75 Years
ALL
No
Sponsors
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Aerovate Therapeutics
INDUSTRY
Responsible Party
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Locations
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Arizona Pulmonary Specialists, Ltd.
Phoenix, Arizona, United States
University of Arizona, Department of Medicine
Tucson, Arizona, United States
UCLA/David Geffen School of Medicine-Pulmonary and Criticial Care
Los Angeles, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 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
UC Davis Medical Center
Sacramento, California, United States
University of California
San Francisco, California, United States
LA Biomedical Research Institute Harbor
Torrance, California, United States
University of Colorado Denver
Aurora, Colorado, United States
National Jewish Health
Denver, Colorado, United States
George Washington University Medical Faculty Associates, Inc.
Washington D.C., District of Columbia, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Orlando Heart Center
Orlando, Florida, United States
Emory University
Atlanta, Georgia, United States
Indiana University Health
Indianapolis, Indiana, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Tufts Medical Center, Inc.
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Nebraska Medical Center- Hematology/Oncology Section
Omaha, Nebraska, United States
The Unviersity of New Mexico - UNM Hospitals
Albuquerque, New Mexico, United States
New York-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States
NYU Langone Seaport
New York, New York, United States
Duke University Medical Center - Duke South Clinic
Durham, North Carolina, 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
Bend Memorial Clinic
Oregon City, Oregon, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
Stat Care Pulmonary Consultants, PLLC
Knoxville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Sentara Medical Group - Sentara Pulmonary & Critical Care Specialists
Norfolk, Virginia, United States
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
Insituto Medico DAMIC
Córdoba, , Argentina
Hospital Italiano de Cordoba
Córdoba, , Argentina
Hospital Dr. Jose Maria Cullen
Santa Fe, , Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Concord Repatriation General Hospital
Concord West, New South Wales, Australia
Nepean Hospital
Kingswood, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Royal Adelaide Hospital
Adelaide, , Australia
Fiona Stanley Hospital
Murdoch, , Australia
AKH - Medizinische Universitat Wien
Vienna, , Austria
Hopital Erasme - Cliniques Universitaires de Bruxelles
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, , Brazil
Heart Institute - University of Sao Paulo
São Paulo, , Brazil
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
Montreal, Quebec, Canada
Centro de Investigaciones Clinicas de la Universidad Catolica
Santiago, , Chile
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, , China
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Groupement Hospitalier Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, Cedex, France
Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel
Bron, , France
Hôpital Nord - CHU Marseille
Marseille, , France
Hopital Arnaud de Villeneuve
Montpellier, , France
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, , France
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, , Germany
University General Hospital Attikon
Athens, , Greece
Cardiosurgery Hospital
Kallithea, , Greece
AHEPA General Hospital of Thessaloniki
Thessaloniki, , Greece
The Lady Davis Carmel Medical Center
Haifa, , Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
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, , Italy
Pauls Stradins Clinical University Hospital
Riga, , Latvia
CICUM San Miguel
Guadalajara, Jalisco, Mexico
Unidad de Investigacion Clinica en Medicina S.C.
Monterrey, Nuevo León, Mexico
Instituto Nacional de Cardiologia Dr Ignacio Chavez Rivera
Mexico City, , Mexico
Universidad Autonoma de Nuevo Leon, Hospital Universitario
Monterrey, , Mexico
Amsterdam UMC, Locatie VUMC
Amsterdam, , Netherlands
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Krakow, , Poland
Bieganski Provincial Specialist Hospital
Lodz, , Poland
Szpital Kliniczny Przemienienia Pańskiego UM im. Marcinkowskiego
Poznan, , Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
Wroclaw, , Poland
Hospital Garcia de Orta, EPE
Almada, , Portugal
Hospital Pulido Valente
Lisbon, , Portugal
CHUPorto
Porto, , Portugal
Cardiopulmonary Research Center
Guaynabo, , Puerto Rico
National University Hospital
Singapore, , Singapore
Tan Tock Seng Hospital
Singapore, , Singapore
Center of Chest Disease Johannesburg
Johannesburg, , South Africa
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
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, , Spain
Norrlands Universitetssjukhus
Umeå, , Sweden
Imperial College Healthcare NHS Trust
London, England, United Kingdom
Golden Jubilee National Hospital
Glasgow, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, , United Kingdom
Countries
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References
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Gillies H, Chakinala MM, Dake BT, Feldman JP, Hoeper MM, Humbert M, Jing ZC, Langley J, McLaughlin VV, Niven RW, Rosenkranz S, Zhang X, Hill NS. IMPAHCT: A randomized phase 2b/3 study of inhaled imatinib for pulmonary arterial hypertension. Pulm Circ. 2024 Mar 25;14(1):e12352. doi: 10.1002/pul2.12352. eCollection 2024 Jan.
Gillies H, Niven R, Dake BT, Chakinala MM, Feldman JP, Hill NS, Hoeper MM, Humbert M, McLaughlin VV, Kankam M. AV-101, a novel inhaled dry-powder formulation of imatinib, in healthy adult participants: a phase 1 single and multiple ascending dose study. ERJ Open Res. 2023 Mar 13;9(2):00433-2022. doi: 10.1183/23120541.00433-2022. eCollection 2023 Mar.
Other Identifiers
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AV-101-002
Identifier Type: -
Identifier Source: org_study_id
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