Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (IMPAHCT-FUL)
- Registration Number
- NCT05557942
- Lead Sponsor
- Aerovate Therapeutics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 186
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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Crossover AV-101 10 mg AV-101 Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 10 milligrams (mg) administered twice daily (BID) via dry powder inhalation. Placebo Crossover AV-101 35 mg AV-101 Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation. Placebo Crossover AV-101 70 mg AV-101 Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation. Continuing AV-101 10 mg AV-101 Participants who previously received AV-101 10 mg in AV-101-002 received AV-101 (imatinib) 10 mg administered BID via dry powder inhalation. Continuing AV-101 35 mg AV-101 Participants who previously received AV-101 35 mg in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation. Continuing AV-101 70 mg AV-101 Participants who previously received AV-101 70 mg in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-emergent Adverse Events From date of first dose to 30 days after date of last dose (up to approximately 21 months) An Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious Adverse Events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (72)
UCLA/David Geffen School of Medicine-Pulmonary and Criticial Care
🇺🇸Los Angeles, California, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Indiana University Health
🇺🇸Indianapolis, Indiana, United States
Tufts Medical Center, Inc.
🇺🇸Boston, Massachusetts, United States
Ospedale San Giuseppe - Fatebenefratelli
🇮🇹Milan, Italy
Mayo Clinic Florida
🇺🇸Jacksonville, Florida, United States
Nexo Salud Investigación Clínica
🇦🇷Buenos Aires, Argentina
Cardiologia Palmero
🇦🇷Buenos Aires, Argentina
Kaiser Permanente - Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Sanatorio de la Trinidad Mitre
🇦🇷Buenos Aires, Argentina
UPMC Presbyterian Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Cliniques Universitaires de Bruxelles Hopital Erasme
🇧🇪Bruxelles, Belgium
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Hospital Dr. Jose Maria Cullen
🇦🇷Santa Fe, Argentina
University of Arizona, Department of Medicine
🇺🇸Tucson, Arizona, United States
UZ Leuven
🇧🇪Leuven, Belgium
The Prince Charles Hospital
🇦🇺Chermside, Queensland, Australia
Jewish General Hospital
🇨🇦Montréal, Quebec, Canada
Insituto Medico DAMIC
🇦🇷Córdoba, Argentina
Sunshine Coast University Hospital
🇦🇺Birtinya, Queensland, Australia
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Hospital Universitario de Toledo
🇪🇸Toledo, Spain
University of California
🇺🇸San Francisco, California, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Hospital Garcia de Orta, EPE
🇵🇹Almada, Portugal
Hospital Pulido Valente
🇵🇹Lisboa, Portugal
Instituto Neumológico del Oriente S.A.
🇨🇴Floridablanca, Colombia
Tan Tock Seng Hospital
🇸🇬Singapore, Singapore
CICUM San Miguel
🇲🇽Guadalajara, Jalisco, Mexico
Yanan Hospital of Kunming City
🇨🇳Kunming, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, China
Arizona Pulmonary Specialist. LTD.
🇺🇸Phoenix, Arizona, United States
GW Medical Faculty Associates
🇺🇸Washington, District of Columbia, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Central South University - The Second Xiangya Hospital
🇨🇳Hunan, China
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
London Health Science Centre
🇨🇦London, Ontario, Canada
Centro de Investigaciones Clinicas de la Universidad Catolica
🇨🇱Santiago, Chile
Guangdong Provincial People's Hospital
🇨🇳Guangdong, China
Peking Union Medical College Hospital
🇨🇳Beijing, China
Chongqing Medical University - The First Affiliated Hospital
🇨🇳Chongqing, China
Gansu Provincial People's Hospital
🇨🇳Lanzhou, China
Groupement Hospitalier Sud - Hôpital Bicêtre
🇫🇷Le Kremlin-Bicêtre, France
Les Hôpitaux Universitaires de Strasbourg
🇫🇷Strasbourg, France
Hopital Arnaud de Villeneuve
🇫🇷Montpellier, France
Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen
🇩🇪Gießen, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
🇩🇪Dresden, Germany
Universitaetsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Hadassah University Hospital - Ein Kerem
🇮🇱Jerusalem, Israel
Azienda Ospedaliero Universitaria Ospedali Riuniti - Foggia
🇮🇹Foggia, Italy
Fondazione IRCCS San Gerardo Dei Tintori
🇮🇹Monza, 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
Unidad de Investigacion Clinica en Medicina S.C.
🇲🇽Monterrey, Nuevo León, Mexico
Krakowski Szpital Specjalistyczny im. Jana Pawla II
🇵🇱Kraków, Poland
Szpital Kliniczny Przemienienia Pańskiego UM im. Marcinkowskiego
🇵🇱Poznań, Poland
Wojewódzki Specjalistyczny Szpital im. Dr. Wł. Biegańskiego w Łodzi
🇵🇱Łódź, Poland
Center of Chest Disease Johannesburg
🇿🇦Johannesburg, South Africa
National University Hospital
🇸🇬Singapore, Singapore
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hosp. Universitario Gran Canaria Doctor Negrin
🇪🇸Las Palmas De Gran Canaria, Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Hospital universtario de Salamanca
🇪🇸Salamanca, Spain
Hosp. Universitario Marques de Valdecilla
🇪🇸Santander, Spain
Imperial College Healthcare NHS Trust
🇬🇧London, United Kingdom
UC Davis Medical Center
🇺🇸Sacramento, California, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Southeast University (SEU) - Zhongda Hospital
🇨🇳Nanjing, China