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

October 9, 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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
186

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1039AAO
        • Sanatorio de la Trinidad Mitre
      • Buenos Aires, Argentina, 1425
        • Nexo Salud Investigacion Clinica
      • 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 Neumologico 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 Hopitaux 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Placebo Crossover AV-101 10 mg
Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 10 milligrams (mg) administered twice daily (BID) via dry powder inhalation.
Drug: AV-101
AV-101 (imatinib) administered via dry powder inhalation
Experimental: Placebo Crossover AV-101 35 mg
Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.
Drug: AV-101
AV-101 (imatinib) administered via dry powder inhalation
Experimental: Placebo Crossover AV-101 70 mg
Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.
Drug: AV-101
AV-101 (imatinib) administered via dry powder inhalation
Experimental: Continuing AV-101 10 mg
Participants who previously received AV-101 10 mg in AV-101-002 received AV-101 (imatinib) 10 mg administered BID via dry powder inhalation.
Drug: AV-101
AV-101 (imatinib) administered via dry powder inhalation
Experimental: Continuing AV-101 35 mg
Participants who previously received AV-101 35 mg in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.
Drug: AV-101
AV-101 (imatinib) administered via dry powder inhalation
Experimental: Continuing AV-101 70 mg
Participants who previously received AV-101 70 mg in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.
Drug: AV-101
AV-101 (imatinib) administered via dry powder inhalation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-emergent Adverse Events
Time Frame: 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.
From date of first dose to 30 days after date of last dose (up to approximately 21 months)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 8, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 8, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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