Clinical trial NCT05557942: Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (IMPAHCT-FUL)
Official title: A Long-Term Extension, Multi-Center Safety Study of AV-101 in Subjects With Pulmonary Arterial Hypertension (PAH) Who Have Completed Study AV-101-002 (IMPAHCT-FUL)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary Arterial Hypertension
Lungs
Pulmonary
PAH
AV-101
imatinib
IMPAHCT
IMPAHCT-FUL
Lead sponsor: Aerovate Therapeutics
Sponsor class: INDUSTRY
First posted: 2022-09-28
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: IMPAHCT-FUL: Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (LTE) Trial was a follow up study to establish the long-term safety of AV-101. Subjects who successfully completed the 24-week placebo-controlled parent trial (AV-101-002, NCT#05036135) were offered the opportunity to continue into this LTE study. Subjects who enrolled in the study were to receive one of three active AV-101 doses until such time as the optimal dose was selected in the parent study.


Eligibility criteria: Key Inclusion Criteria:

To be eligible, a participant is required to be or have:

* Consented to participate in the LTE and has successfully completed the placebo-controlled 24-week Study AV-101-002.

Key Exclusion Criteria:

Subjects meeting any of the following criteria:

* The Investigator believes that it would not be in the best interest of the subject to be included in the LTE e.g., for clinical or social reasons.
* Subjects who were not compliant with study medication in AV-101-002 as assessed by the Investigator.

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events
timeFrame: From date of first dose to 30 days after date of last dose (up to approximately 21 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Pulmonary Specialist. LTD.
state: Arizona
city: Tucson
country: United States
facility: University of Arizona, Department of Medicine
state: Arizona
city: Los Angeles
country: United States
facility: UCLA/David Geffen School of Medicine-Pulmonary and Criticial Care
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente - Los Angeles Medical Center
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: San Francisco
country: United States
facility: University of California
state: California
city: Washington
country: United States
facility: GW Medical Faculty Associates
state: District of Columbia
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Boston
country: United States
facility: Tufts Medical Center, Inc.
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Buenos Aires
country: Argentina
facility: Cardiologia Palmero
city: Buenos Aires
country: Argentina
facility: Nexo Salud Investigación Clínica
city: Buenos Aires
country: Argentina
facility: Sanatorio de la Trinidad Mitre
city: Córdoba
country: Argentina
facility: Insituto Medico DAMIC
city: Santa Fe
country: Argentina
facility: Hospital Dr. Jose Maria Cullen
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Birtinya
country: Australia
facility: Sunshine Coast University Hospital
state: Queensland
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires de Bruxelles Hopital Erasme
city: Leuven
country: Belgium
facility: UZ Leuven
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: London
country: Canada
facility: London Health Science Centre
state: Ontario
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Santiago
country: Chile
facility: Centro de Investigaciones Clinicas de la Universidad Catolica
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Chongqing
country: China
facility: Chongqing Medical University - The First Affiliated Hospital
city: Guangdong
country: China
facility: Guangdong Provincial People's Hospital
city: Hunan
country: China
facility: Central South University - The Second Xiangya Hospital
city: Kunming
country: China
facility: Yanan Hospital of Kunming City
city: Lanzhou
country: China
facility: Gansu Provincial People's Hospital
city: Nanjing
country: China
facility: Southeast University (SEU) - Zhongda Hospital
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Floridablanca
country: Colombia
facility: Instituto Neumológico del Oriente S.A.
city: Le Kremlin-Bicêtre
country: France
facility: Groupement Hospitalier Sud - Hôpital Bicêtre
city: Montpellier
country: France
facility: Hopital Arnaud de Villeneuve
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus TU Dresden
city: Gießen
country: Germany
facility: Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Jerusalem
country: Israel
facility: Hadassah University Hospital - Ein Kerem
city: Foggia
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti - Foggia
city: Milan
country: Italy
facility: Ospedale San Giuseppe - Fatebenefratelli
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo Dei Tintori
city: Palermo
country: Italy
facility: Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Rome
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Umberto I
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Guadalajara
country: Mexico
facility: CICUM San Miguel
state: Jalisco
city: Monterrey
country: Mexico
facility: Unidad de Investigacion Clinica en Medicina S.C.
state: Nuevo León
city: Kraków
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II
city: Poznań
country: Poland
facility: Szpital Kliniczny Przemienienia Pańskiego UM im. Marcinkowskiego
city: Łódź
country: Poland
facility: Wojewódzki Specjalistyczny Szpital im. Dr. Wł. Biegańskiego w Łodzi
city: Almada
country: Portugal
facility: Hospital Garcia de Orta, EPE
city: Lisboa
country: Portugal
facility: Hospital Pulido Valente
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Johannesburg
country: South Africa
facility: Center of Chest Disease Johannesburg
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Las Palmas De Gran Canaria
country: Spain
facility: Hosp. Universitario Gran Canaria Doctor Negrin
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Salamanca
country: Spain
facility: Hospital universtario de Salamanca
city: Santander
country: Spain
facility: Hosp. Universitario Marques de Valdecilla
city: Toledo
country: Spain
facility: Hospital Universitario de Toledo
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
References: