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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.
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  • Patients who have a history of certain dental conditions.
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  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Pauls Stradins Clinical University Hospital Riga Latvia
Hospital Universitario 12 De Octubre Madrid Spain
Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego Lodz Poland
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Onassis Cardiac Surgery Center Kallithea Greece
Multimedica S.p.A. Milan Italy
Evangelismos S.A. Athens Greece
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Hospital Clinic De Barcelona Barcelona Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Justus-Liebig-Universitaet Giessen Giessen Germany
Muenchen Klinik gGmbH Munich Germany
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Istituto Mediterraneo Per I Trapianti E Terapie Ad Alta Specializzazione S.r.l. Palermo Italy
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Region Vaesterbotten Umea Sweden
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Hospital Universitario Virgen De La Victoria Malaga Spain
Hykahtyk Uetxxmrpbpyhz Mlqkrgg Dc Vbjudvznbn Santander Spain
Ukegdjebdl Hrdyggyh Cguzisf Cologne Germany
Anqvifprn Uxx Amsterdam The Netherlands
Aoeiieylxg Pcxpantw Hkufcvrb Dq Mznaxjjxv Marseille France
Arhksrs Ovsuptlemdf Uodvzdgtlcqdk Obkebozp Rosoqkp Foggia Italy
Ulnveferpj Dujmr Speky Ds Rkjg Ly Sayquutm Rome Italy
Fmbzwrmyk Pmcd Lb Iakfbnfpbmxpu Bzxkgbqhk Dch Hfbwpezz Urkzflljiloab Lx Ppx Madrid Spain
Hbjxrgro Vbeb dnyenonx Barcelona Spain
Kiimelyxz Ssmphqd Smzfebyvsinxokk ik Jptf Psvzp Ip Cracow Poland
Hzqqwkdz Ucfvpjsugvvwas Spkzosfyar &enpwkk Hcltngm di Hqydzedbtla STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
06.11.2022
Belgium Belgium
Not recruiting
06.11.2022
Czechia Czechia
Not recruiting
06.11.2022
France France
Not recruiting
06.11.2022
Germany Germany
Not recruiting
06.11.2022
Greece Greece
Not recruiting
06.11.2022
Ireland Ireland
Not recruiting
06.11.2022
Italy Italy
Not recruiting
06.11.2022
Latvia Latvia
Not recruiting
06.11.2022
Poland Poland
Not recruiting
06.11.2022
Portugal Portugal
Not recruiting
06.11.2022
Spain Spain
Not recruiting
06.11.2022
Sweden Sweden
Not recruiting
06.11.2022
The Netherlands The Netherlands
Not recruiting
06.11.2022

Trial locations

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.

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 ID:
2023-508735-31-00
Protocol code:
AV-101-003
NCT ID:
NCT05557942
Trial Phase:
Therapeutic confirmatory (Phase III)

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  • A Study of ROC-101 Hydrochloride for Patients with Pulmonary Arterial Hypertension and Pulmonary Hypertension Associated with Interstitial Lung Disease

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