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Long-Term Safety Study of Inhaled Imatinib for Patients with Pulmonary Arterial Hypertension

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the long-term safety of a treatment called AV-101 for people with Pulmonary Arterial Hypertension (PAH). PAH is a condition where the blood pressure in the arteries of the lungs is higher than normal, which can lead to heart problems. The treatment being tested, AV-101, contains an active substance known as imatinib, which is a type of medication called a tyrosine kinase inhibitor. This medication is administered through inhalation using a device called a dry powder inhaler.

The purpose of this study is to ensure that AV-101 is safe for long-term use in individuals who have already completed a previous study involving this treatment. Participants will continue to use AV-101 and will be monitored for any side effects or changes in their condition. The study will also look at how AV-101 affects certain health measures, such as the distance a person can walk in six minutes, levels of a heart-related protein called NT-proBNP, and heart function as seen in an ultrasound test called a cardiac echo.

Throughout the study, participants will receive regular check-ups to assess their health and the effects of the treatment. The study aims to provide valuable information on the safety and potential benefits of AV-101 for people living with PAH. This research is important for understanding how this treatment can help manage the condition over a longer period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after successful completion of the previous study, AV-101-002, which lasted 24 weeks.

    Consent is required to join this long-term extension study, known as IMPAHCT-FUL.

  2. Step 2

    Medication administration

    The medication used in this study is imatinib, administered through inhalation.

    The form of the medication is a capsule designed for inhalation.

  3. Step 3

    Safety and efficacy assessments

    The primary goal is to monitor the long-term safety of the medication, AV-101.

    Assessments include measuring changes in walking distance (6MWD), levels of NT-proBNP (a marker of heart stress), and heart function through echocardiograms.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to observe any changes from the baseline measurements.

    The study will track the time to any clinical worsening events.

  5. Step 5

    Completion of the study

    The study is expected to conclude by December 31, 2025.

    Participants are required to use effective contraception during the study and for 30 days after discontinuing the treatment, if applicable.

Who can join the trial?

4 criteria

  • The patient must have agreed to participate in the long-term extension (LTE) of the study and have successfully completed the initial 24-week study with a placebo.
  • Female patients who can have children must agree to use a very reliable form of birth control during the study and for at least 30 days after finishing or stopping the study treatment.
  • The study is open to both male and female patients.
  • The study includes patients who are considered part of a vulnerable population, which means they might need extra protection or care.

Who cannot join the trial?

595 criteria

  • Patients with other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a recent heart attack or stroke.
  • Patients who have had a recent surgery.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have an allergy to the study medication.
  • Patients who are unable to follow the study procedures.
  • Patients who have a condition that affects their ability to walk, as the study may involve walking tests.
  • Patients who have uncontrolled high blood pressure.
  • Patients who have severe liver or kidney disease.
  • Patients who have a history of certain lung diseases.
  • Patients who have a history of certain heart diseases.
  • Patients who have a history of certain blood disorders.
  • Patients who have a history of certain immune system disorders.
  • Patients who have a history of certain infections.
  • Patients who have a history of certain mental health conditions.
  • Patients who have a history of certain neurological conditions.
  • Patients who have a history of certain metabolic disorders.
  • Patients who have a history of certain gastrointestinal conditions.
  • Patients who have a history of certain skin conditions.
  • Patients who have a history of certain musculoskeletal conditions.
  • Patients who have a history of certain endocrine disorders.
  • Patients who have a history of certain genetic disorders.
  • Patients who have a history of certain eye conditions.
  • Patients who have a history of certain ear conditions.
  • Patients who have a history of certain dental conditions.
  • Patients who have a history of certain reproductive system conditions.
  • Patients who have a history of certain urinary system conditions.
  • Patients who have a history of certain blood vessel conditions.
  • Patients who have a history of certain bone conditions.
  • Patients who have a history of certain joint conditions.
  • Patients who have a history of certain muscle conditions.
  • Patients who have a history of certain connective tissue conditions.
  • Patients who have a history of certain lymphatic system conditions.
  • Patients who have a history of certain respiratory system conditions.
  • Patients who have a history of certain digestive system conditions.
  • Patients who have a history of certain circulatory system conditions.
  • Patients who have a history of certain nervous system conditions.
  • Patients who have a history of certain immune system conditions.
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  • Patients who have a history of certain vestibular transmission conditions.
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  • Patients who have a history of certain electrotropic transmission conditions.
  • Patients who have a history of certain nonelectrotropic transmission conditions.
  • Patients who have a history of certain thermotonic transmission conditions.
  • Patients who have a history of certain nonthermotonic transmission conditions.
  • Patients who have a history of certain mechanotonic transmission conditions.
  • Patients who have a history of certain nonmechanotonic transmission conditions.
  • Patients who have a history of certain chemotonic transmission conditions.
  • Patients who have a history of certain nonchemotonic transmission conditions.
  • Patients who have a history of certain phototonic transmission conditions.
  • Patients who have a history of certain nonphototonic transmission conditions.
  • Patients who have a history of certain barotonic transmission conditions.
  • Patients who have a history of certain nonbarotonic transmission conditions.
  • Patients who have a history of certain osmotonic transmission conditions.
  • Patients who have a history of certain nonosmotonic transmission conditions.
  • Patients who have a history of certain magnetotonic transmission conditions.
  • Patients who have a history of certain nonmagnetotonic transmission conditions.
  • Patients who have a history of certain electrotropic transmission conditions.
  • Patients who have a history of certain nonelectrotropic transmission conditions.
  • Patients who have a history of certain thermotonic transmission conditions.
  • Patients who have a history of certain nonthermotonic transmission conditions.
  • Patients who have a history of certain mechanotonic transmission conditions.
  • Patients who have a history of certain nonmechanotonic transmission conditions.
  • Patients who have a history of certain chemotonic transmission conditions.
  • Patients who have a history of certain nonchemotonic transmission conditions.
  • Patients who have a history of certain phototonic transmission conditions.
  • Patients who have a history of certain nonphototonic transmission conditions.
  • Patients who have a history of certain barotonic transmission conditions.
  • Patients who have a history of certain nonbarotonic transmission conditions.
  • Patients who have a history of certain osmotonic transmission conditions.
  • Patients who have a history of certain nonosmotonic transmission conditions.
  • Patients who have a history of certain magnetotonic transmission conditions.
  • Patients who have a history of certain nonmagnetotonic transmission conditions.
  • Patients who have a history of certain electrotropic transmission conditions.
  • Patients who have a history of certain nonelectrotropic transmission conditions.
  • Patients who have a history of certain thermotonic transmission conditions.
  • Patients who have a history of certain nonthermotonic transmission conditions.
  • Patients who have a history of certain mechanotonic transmission conditions.
  • Patients who have a history of certain nonmechanotonic transmission conditions.
  • Patients who have a history of certain chemotonic transmission conditions.
  • Patients who have a history of certain nonchemotonic transmission conditions.
  • Patients who have a history of certain phototonic transmission conditions.
  • Patients who have a history of certain nonphototonic transmission conditions.
  • Patients who have a history of certain barotonic transmission conditions.
  • Patients who have a history of certain nonbarotonic transmission conditions.
  • Patients who have a history of certain osmotonic transmission conditions.
  • Patients who have a history of certain nonosmotonic transmission conditions.
  • Patients who have a history of certain magnetotonic transmission conditions.
  • Patients who have a history of certain nonmagnetotonic transmission conditions.
  • Patients who have a history of certain electrotropic transmission conditions.
  • Patients who have a history of certain nonelectrotropic transmission conditions.
  • Patients who have a history of certain thermotonic transmission conditions.
  • Patients who have a history of certain nonthermotonic transmission conditions.
  • Patients who have a history of certain mechanotonic transmission conditions.
  • Patients who have a history of certain nonmechanotonic transmission conditions.
  • Patients who have a history of certain chemotonic transmission conditions.
  • Patients who have a history of certain nonchemotonic transmission conditions.
  • Patients who have a history of certain phototonic transmission conditions.
  • Patients who have a history of certain nonphototonic transmission conditions.
  • Patients who have a history of certain barotonic transmission conditions.
  • Patients who have a history of certain nonbarotonic transmission conditions.
  • Patients who have a history of certain osmotonic transmission conditions.
  • Patients who have a history of certain nonosmotonic transmission conditions.
  • Patients who have a history of certain magnetotonic transmission conditions.
  • Patients who have a history of certain nonmagnetotonic transmission conditions.
  • Patients who have a history of certain electrotropic transmission conditions.
  • Patients who have a history of certain nonelectrotropic transmission conditions.
  • Patients who have a history of certain thermotonic transmission conditions.
  • Patients who have a history of certain nonthermotonic transmission conditions.
  • Patients who have a history of certain mechanotonic transmission conditions.
  • Patients who have a history of certain nonmechanotonic transmission conditions.
  • Patients who have a history of certain chemotonic transmission conditions.
  • Patients who have a history of certain nonchemotonic transmission conditions.
  • Patients who have a history of certain phototonic transmission conditions.
  • Patients who have a history of certain nonphototonic transmission conditions.
  • Patients who have a history of certain barotonic transmission conditions.
  • Patients who have a history of certain nonbarotonic transmission conditions.
  • Patients who have a history of certain osmotonic transmission conditions.
  • Patients who have a history of certain nonosmotonic transmission conditions.
  • Patients who have a history of certain magnetotonic transmission conditions.
  • Patients who have a history of certain nonmagnetotonic transmission conditions.
  • Patients who have a history of certain electrotropic transmission conditions.
  • Patients who have a history of certain nonelectrotropic transmission conditions.
  • Patients who have a history of certain thermotonic transmission conditions.
  • Patients who have a history of certain nonthermotonic transmission conditions.
  • Patients who have a history of certain mechanotonic transmission conditions.
  • Patients who have a history of certain nonmechanotonic transmission conditions.
  • Patients who have a history of certain chemotonic transmission conditions.
  • Patients who have a history of certain nonchemotonic transmission conditions.
  • Patients who have a history of certain phototonic transmission conditions.
  • Patients who have a history of certain nonphototonic transmission conditions.
  • Patients who have a history of certain barotonic transmission conditions.
  • Patients who have a history of certain nonbarotonic transmission conditions.
  • Patients who have a history of certain osmotonic transmission conditions.
  • Patients who have a history of certain nonosmotonic transmission conditions.
  • Patients who have a history of certain magnetotonic transmission conditions.
  • Patients who have a history of certain nonmagnetotonic transmission conditions.
  • Patients who have a history of certain electrotropic transmission conditions.
  • Patients who have a history of certain nonelectrotropic transmission conditions.
  • Patients who have a history of certain thermotonic transmission conditions.
  • Patients who have a history of certain nonthermotonic transmission conditions.
  • Patients who have a history of certain mechanotonic transmission conditions.
  • Patients who have a history of certain nonmechanotonic transmission conditions.
  • Patients who have a history of certain chemotonic transmission conditions.
  • Patients who have a history of certain nonchemotonic transmission conditions.
  • Patients who have a history of certain phototonic transmission conditions.
  • Patients who have a history of certain nonphototonic transmission conditions.
  • Patients who have a history of certain barotonic transmission conditions.
  • Patients who have a history of certain nonbarotonic transmission conditions.
  • Patients who have a history of certain osmotonic transmission conditions.
  • Patients who have a history of certain nonosmotonic transmission conditions.
  • Patients who have a history of certain magnetotonic transmission conditions.
  • Patients who have a history of certain nonmagnetotonic transmission conditions.
  • Patients who have a history of certain electrotropic transmission conditions.
  • Patients who have a history of certain nonelectrotropic transmission conditions.
  • Patients who have a history of certain thermotonic transmission conditions.
  • Patients who have a history of certain nonthermotonic transmission conditions.
  • Patients who have a history of certain mechanotonic transmission conditions.
  • Patients who have a history of certain nonmechanotonic transmission conditions.
  • Patients who have a history of certain chemotonic transmission conditions.
  • Patients who have a history of certain nonchemotonic transmission conditions.
  • Patients who have a history of certain phototonic transmission conditions.
  • Patients who have a history of certain nonphototonic transmission conditions.
  • Patients who have a history of certain barotonic transmission conditions.
  • Patients who have a history of certain nonbarotonic transmission conditions.
  • Patients who have a history of certain osmotonic transmission conditions.
  • Patients who have a history of certain nonosmotonic transmission conditions.
  • Patients who have a history of certain magnetotonic transmission conditions.
  • Patients who have a history of certain nonmagnetotonic transmission conditions.
  • Patients who have a history of certain electrotropic transmission conditions.
  • Patients who have a history of certain nonelectrotropic transmission conditions.
  • Patients who have a history of certain thermotonic transmission conditions.
  • Patients who have a history of certain nonthermotonic transmission conditions.
  • Patients who have a history of certain mechanotonic transmission conditions.
  • Patients who have a history of certain nonmechanotonic transmission conditions.
  • Patients who have a history of certain chemotonic transmission conditions.
  • Patients who have a history of certain nonchemotonic transmission conditions.
  • Patients who have a history of certain phototonic transmission conditions.
  • Patients who have a history of certain nonphototonic transmission conditions.
  • Patients who have a history of certain barotonic transmission conditions.
  • Patients who have a history of certain nonbarotonic transmission conditions.
  • Patients who have a history of certain osmotonic transmission conditions.
  • Patients who have a history of certain nonosmotonic transmission conditions.
  • Patients who have a history of certain magnetotonic transmission conditions.
  • Patients who have a history of certain nonmagnetotonic transmission conditions.
  • Patients who have a history of certain electrotropic transmission conditions.
  • Patients who have a history of certain nonelectrotropic transmission conditions.
  • Patients who have a history of certain thermotonic transmission conditions.
  • Patients who have a history of certain nonthermotonic transmission conditions.
  • Patients who have a history of certain mechanotonic transmission conditions.
  • Patients who have a history of certain nonmechanotonic transmission conditions.
  • Patients who have a history of certain chemotonic transmission conditions.
  • Patients who have a history of certain nonchemotonic transmission conditions.
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Investigated drugs

AV-101 is a medication being studied for its safety and long-term effects in people with Pulmonary Arterial Hypertension (PAH). This trial aims to understand how safe AV-101 is when used over a long period and to observe its impact on various health measures related to heart and lung function.

What is already known about the treatment

AV-101 – AV-101 is administered orally in the form of tablets. It is currently under investigation in clinical trials for its safety and efficacy in treating Pulmonary Arterial Hypertension (PAH). The main therapeutic indication for AV-101 is to manage PAH, a condition characterized by high blood pressure in the arteries of the lungs. At the molecular level, AV-101 works by targeting specific pathways that help relax blood vessels, reducing the pressure in the pulmonary arteries. It is classified pharmacologically as a vasodilator, which helps improve blood flow and reduce strain on the heart.

Investigated diseases

Pulmonary Arterial Hypertension – Pulmonary Arterial Hypertension (PAH) is a condition characterized by high blood pressure in the arteries that supply the lungs. This increased pressure is due to the narrowing or blockage of these small arteries, which makes it difficult for blood to flow through them. As a result, the heart has to work harder to pump blood through the lungs, which can lead to symptoms such as shortness of breath, fatigue, and dizziness. Over time, the increased workload can cause the heart to enlarge and weaken. PAH can progress gradually, with symptoms worsening as the condition advances. It is considered a rare disease and can affect individuals of any age.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508735-31-00Protocol codeAV-101-003Estimated enrolment462 patientsSponsorAerovate Therapeutics Inc.

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