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

June 20, 2024 updated by: Aerovate Therapeutics

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

462

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1039AAO
        • Sanatorio de la Trinidad Mitre
      • Buenos Aires, Argentina, 1425
        • Nexo Salud Investigación Clínica
      • Buenos Aires, Argentina, 1425
        • Cardiologia Palmero
      • Córdoba, Argentina, 5009
        • Insituto Medico DAMIC
      • Santa Fe, Argentina, S3000EOZ
        • Hospital Dr. Jose Maria Cullen
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Sunshine Coast University Hospital
      • Chermside, Queensland, Australia, 4032
        • The Prince Charles Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
  • Belgium
      • Bruxelles, Belgium, 1070
        • Cliniques Universitaires de Bruxelles Hopital Erasme
      • Leuven, Belgium, 3000
        • UZ Leuven
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hospital
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Science Centre
    • Quebec
      • Montréal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
  • Chile
      • Santiago, Chile, 8330024
        • Centro de Investigaciones Clinicas de la Universidad Catolica
  • China
      • Beijing, China, 100730
        • Peking Union Medical College Hospital
      • Chongqing, China, 40016
        • Chongqing Medical University - The First Affiliated Hospital
      • Guangdong, China, 510000
        • Guangdong Provincial People's Hospital
      • Hunan, China, 410011
        • Central South University - The Second Xiangya Hospital
      • Kunming, China, 650051
        • Yanan Hospital of Kunming City
      • Lanzhou, China, 730000
        • Gansu Provincial People's Hospital
      • Nanjing, China, 210009
        • Southeast University (SEU) - Zhongda Hospital
      • Tianjin, China, 300052
        • Tianjin Medical University General Hospital
  • Colombia
      • Floridablanca, Colombia, 20-97
        • Instituto Neumológico del Oriente S.A.
  • France
      • Le Kremlin-Bicêtre, France, 94275
        • Groupement Hospitalier Sud - Hôpital Bicêtre
      • Montpellier, France, 34295
        • Hopital Arnaud de Villeneuve
      • Strasbourg, France, 67091
        • Les Hôpitaux Universitaires de Strasbourg
  • Germany
      • Dresden, Germany, 1307
        • Universitaetsklinikum Carl Gustav Carus TU Dresden
      • Gießen, Germany, 35392
        • Universitaetsklinikum Giessen Und Marburg Gmbh Standort Giessen
      • Heidelberg, Germany, 69126
        • Universitaetsklinikum Heidelberg
  • Israel
      • Jerusalem, Israel, 91999
        • Hadassah University Hospital - Ein Kerem
  • Italy
      • Foggia, Italy, 71122
        • Azienda Ospedaliero Universitaria Ospedali Riuniti - Foggia
      • Milan, Italy, 20123
        • Ospedale San Giuseppe - Fatebenefratelli
      • Monza, Italy, 20900
        • Fondazione IRCCS San Gerardo dei Tintori
      • Palermo, Italy, 90127
        • Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo
      • Rome, Italy, 137
        • Azienda Ospedaliera Universitaria Policlinico Umberto I
  • Latvia
      • Riga, Latvia, 1002
        • Pauls Stradins Clinical University Hospital
  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44160
        • CICUM San Miguel
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64718
        • Unidad de Investigacion Clinica en Medicina S.C.
  • Poland
      • Kraków, Poland, 31-202
        • Krakowski Szpital Specjalistyczny Im. Jana Pawla Ii
      • Poznań, Poland, 61-848
        • Szpital Kliniczny Przemienienia Pańskiego UM im. Marcinkowskiego
      • Łódź, Poland, 91-347
        • Wojewódzki Specjalistyczny Szpital im. Dr. Wł. Biegańskiego w Łodzi
  • Portugal
      • Almada, Portugal, 2805-267
        • Hospital Garcia de Orta, EPE
      • Lisboa, Portugal, 1769-001
        • Hospital Pulido Valente
  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital
      • Singapore, Singapore, 308433
        • Tan Tock Seng Hospital
  • South Africa
      • Johannesburg, South Africa, 2193
        • Center of Chest Disease Johannesburg
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Las Palmas De Gran Canaria, Spain, 35010
        • Hosp. Universitario Gran Canaria Doctor Negrin
      • Madrid, Spain, 28014
        • Hospital 12 de Octubre
      • Málaga, Spain, 29071
        • Hospital Universitario Virgen de la Victoria
      • Salamanca, Spain, 37007
        • Hospital universtario de Salamanca
      • Santander, Spain, 39003
        • Hosp. Universitario Marques de Valdecilla
      • Toledo, Spain, 45007
        • Hospital Universitario de Toledo
  • United Kingdom
      • London, United Kingdom, W12 0HS
        • Imperial College Healthcare NHS Trust
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Arizona Pulmonary Specialist. LTD.
      • Tucson, Arizona, United States, 85724
        • University of Arizona, Department of Medicine
    • California
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente - Los Angeles Medical Center
      • Los Angeles, California, United States, 90024
        • UCLA/David Geffen School of Medicine-Pulmonary and Criticial Care
      • Sacramento, California, United States, 95817
        • UC Davis Medical Center
      • San Francisco, California, United States, 94143
        • University of California
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • GW Medical Faculty Associates
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Florida
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center, Inc.
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Presbyterian Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: low dose AV-101
Drug: AV-101
AV-101 (imatinib) administered via dry powder inhalation
Experimental: medium dose AV-101
Drug: AV-101
AV-101 (imatinib) administered via dry powder inhalation
Experimental: high dose AV-101
Drug: AV-101
AV-101 (imatinib) administered via dry powder inhalation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability of AV-101
Time Frame: Through Study completion, anticipated to be approximately 3 years
as measured by Incidence of Adverse Events
Through Study completion, anticipated to be approximately 3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the 6MWD
Time Frame: Baseline, weeks 4,12 and 24, and every 12 weeks up to study completion
Baseline, weeks 4,12 and 24, and every 12 weeks up to study completion
Change from baseline in NT-proBNP
Time Frame: Baseline, weeks 4,12 and 24, and every 12 weeks up to study completion
Baseline, weeks 4,12 and 24, and every 12 weeks up to study completion
Change from baseline in Right Ventricular (RV) function (e.g. TAPSE, RVFAC, RV/PA coupling, TRJV etc.) as measured by Resting Transthoracic Echocardiography
Time Frame: Baseline, week 24, and every 12 weeks up to study completion
Baseline, week 24, and every 12 weeks up to study completion
Time to Clinical Worsening
Time Frame: Through Study completion, anticipated to be approximately 3 years

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aerovate Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2022

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

September 15, 2022

First Submitted That Met QC Criteria

September 23, 2022

First Posted (Actual)

September 28, 2022

Study Record Updates

Last Update Posted (Actual)

June 21, 2024

Last Update Submitted That Met QC Criteria

June 20, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AV-101-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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