Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (IMPAHCT-FUL)

Pulmonary Arterial Hypertension Clinical Trial

— 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05557942
• Other study ID #: AV-101-003
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 2, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Aerovate Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

IMPAHCT-FUL: Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (LTE) Trial is a follow up study to establish the long-term safety of AV-101. The long-term effects of AV-101 on efficacy measures will also be assessed. Subjects who successfully complete the 24-week placebo-controlled parent trial (AV-101-002) will be offered the opportunity to continue into this LTE study. Subjects who enroll in the study will receive one of three active AV-101 doses until such time as the optimal dose has been selected in the parent study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 462
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• AV-101
AV-101 (imatinib) administered via dry powder inhalation

Locations

Country	Name	City	State
Argentina	Cardiologia Palmero	Buenos Aires
Argentina	Nexo Salud Investigación Clínica	Buenos Aires
Argentina	Sanatorio de la Trinidad Mitre	Buenos Aires
Argentina	Insituto Medico DAMIC	Córdoba
Argentina	Hospital Dr. Jose Maria Cullen	Santa Fe
Australia	Sunshine Coast University Hospital	Birtinya	Queensland
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	The Prince Charles Hospital	Chermside	Queensland
Australia	The Alfred Hospital	Melbourne	Victoria
Belgium	Cliniques Universitaires de Bruxelles Hopital Erasme	Bruxelles
Belgium	UZ Leuven	Leuven
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	Tianjin Medical University General Hospital	Tianjin
Colombia	Instituto Neumológico del Oriente S.A.	Floridablanca
France	Groupement Hospitalier Sud - Hôpital Bicêtre	Le Kremlin-Bicêtre
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	Gießen
Germany	Universitaetsklinikum Heidelberg	Heidelberg
Israel	Hadassah University Hospital - Ein Kerem	Jerusalem
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti - Foggia	Foggia
Italy	Ospedale San Giuseppe - Fatebenefratelli	Milan
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
Latvia	Pauls Stradins Clinical University Hospital	Riga
Mexico	CICUM San Miguel	Guadalajara	Jalisco
Mexico	Unidad de Investigacion Clinica en Medicina S.C.	Monterrey	Nuevo León
Poland	Krakowski Szpital Specjalistyczny im. Jana Pawla II	Kraków
Poland	Wojewódzki Specjalistyczny Szpital im. Dr. Wl. Bieganskiego w Lodzi	Lódz
Poland	Szpital Kliniczny Przemienienia Panskiego UM im. Marcinkowskiego	Poznan
Portugal	Hospital Garcia de Orta, EPE	Almada
Portugal	Hospital Pulido Valente	Lisboa
Singapore	National University Hospital	Singapore
Singapore	Tan Tock Seng Hospital	Singapore
South Africa	Center of Chest Disease Johannesburg	Johannesburg
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	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
United Kingdom	Imperial College Healthcare NHS Trust	London
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	Tufts Medical Center, Inc.	Boston	Massachusetts
United States	Ohio State University	Columbus	Ohio
United States	Indiana University Health	Indianapolis	Indiana
United States	Mayo Clinic Florida	Jacksonville	Florida
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	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Arizona Pulmonary Specialist. 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	University of Arizona, Department of Medicine	Tucson	Arizona
United States	GW Medical Faculty Associates	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Aerovate Therapeutics

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Canada,  Chile,  China,  Colombia,  France,  Germany,  Israel,  Italy,  Latvia,  Mexico,  Poland,  Portugal,  Singapore,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in the 6MWD		Baseline, weeks 4,12 and 24, and every 12 weeks up to study completion
Other	Change from baseline in NT-proBNP		Baseline, weeks 4,12 and 24, and every 12 weeks up to study completion
Other	Change from baseline in Right Ventricular (RV) function (e.g. TAPSE, RVFAC, RV/PA coupling, TRJV etc.) as measured by Resting Transthoracic Echocardiography		Baseline, week 24, and every 12 weeks up to study completion
Other	Time to Clinical Worsening	Clinical Worsening Events will be defined as: Death (all causes); Hospitalization for worsening PAH; Initiation of parenteral prostanoids (subcutaneous or intravenous infusion); = 15% decline from baseline in 6MWD accompanied with continued or worsening to WHO FC III or IV symptoms. The decline in 6MWD must be confirmed with a repeat test on a different day within 2 weeks Time to clinical worsening is the number of days between the earliest occurrence of the clinical worsening component and the date of the first dose in the parent trial.	Through Study completion, anticipated to be approximately 3 years
Primary	Safety and tolerability of AV-101	as measured by Incidence of Adverse Events	Through Study completion, anticipated to be approximately 3 years