NCT05036135CompletedPhase 2/3
Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial (IMPAHCT) or A Phase 2b/3, Randomized, Controlled, 24-week Dose Ranging and Confirmatory Study of AV-101 in Patients with PAH
IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients with Pulmonary Arterial Hypertension (PAH)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 23 May 2024
Brief summary (registry, in English)
The objective of the study is to establish an optimal dose based primarily upon the change in PVR assessed by right heart catheterization (RHC) and the safety and tolerability of AV-101 as evaluated in the Phase 2b Part of the study. The optimal dose will be taken into the Phase 3 Part of the study where the placebo-corrected change in 6MWD after 24 weeks of treatment will be used as the primary endpoint.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 205 (actual)
- First submitted
- 1 Feb 2024
- Start date
- Jun 2022
- Lead sponsor
- Aerovate Therapeutics Inc.
- NCT number
- NCT05036135
- EU CT number
- 2023-508734-34-00
- EudraCT number
- 2021-001910-13
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 205
- 46 sites in 14 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Pulmonary hypertension (PH) belonging to Groups 2 to 5 of the 2018 NICE classification and Group 1 diagnosed with Portopulmonary Hypertension.
Lab values
- A history of left ventricular ejection fraction (LVEF) ≤ 40% on echocardiogram within 12 months of screening, or clinically significant ischemic, mitral or aortic valve disease, or constrictive heart disease, in the opinion of the Investigator
Other
- Pregnant or breast-feeding females
Who the study is looking for
- Male or female between 18 and 75 years of age inclusive at the Screening Visit
- A diagnosis of PAH belonging to one of the subgroups of the NICE classification of Group 1*: a. I/HPAH, PAH-CTD, b. PAH due to drugs and/or toxins/chemicals (having been in the care of the investigator for at least one year with no relapses of drug or toxin/chemical abuse), c. HIV associated or d. PAH due to repaired congenital heart disease (at least 1 year since repair). *Excluding patients with Portopulmonary Hypertension
- World Health Organization (WHO) Functional Class II, III or IV symptoms
- Must be able to walk a distance of at least 100 m but no more than 475 m during the screening 6-minute walk test.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (46)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Completed |
| Hopital Erasme Coordinator of this site? Confirm its status | Anderlecht | Belgium | Completed |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Completed |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Completed |
| University Hospital Cologne AöR Coordinator of this site? Confirm its status | Cologne | Germany | Completed |
| Technische Universität Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Completed |
| Justus-Liebig-Universitaet Giessen Coordinator of this site? Confirm its status | Giessen | Germany | Completed |
| Thoraxklinik Heidelberg gGmbH Coordinator of this site? Confirm its status | Heidelberg | Germany | Completed |
| Muenchen Klinik gGmbH Coordinator of this site? Confirm its status | Munich | Germany | Completed |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| El Hospital Universitario De Gran Canaria Dr. Negrin Coordinator of this site? Confirm its status | Las Palmas De Gran Canaria | Spain | Completed |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Completed |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Completed |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Completed |
| Hospital Universitario de Toledo Coordinator of this site? Confirm its status | Toledo | Spain | Completed |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Completed |
| Bicetre Hospital Coordinator of this site? Confirm its status | Le Kremlin Bicetre Cedex | France | Completed |
| Assistance Publique Hôpitaux de Marseille Coordinator of this site? Confirm its status | Marseille | France | Completed |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Completed |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex | France | Completed |
| Evangelismos S A Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| Onassis Cardiac Surgery Center Coordinator of this site? Confirm its status | Kallithea | Greece | Completed |
| University General Hospital of Thessaloniki - AHEPA Coordinator of this site? Confirm its status | Thessaloniki | Greece | Completed |
| Mater Misericordiae University Hospital Coordinator of this site? Confirm its status | Dublin 7 | Ireland | Completed |
| Azienda Ospedaliero Universitaria Ospedali Riuniti Coordinator of this site? Confirm its status | Foggia | Italy | Completed |
| Multimedica S.p.A. Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Completed |
| Azienda Ospedaliera dei Colli Coordinator of this site? Confirm its status | Naples | Italy | Completed |
| Istituto Mediterraneo Per I Trapianti E Terapie Ad Alta Specializzazione S.r.l. I.S.M.E.T.T. S.r.l. Coordinator of this site? Confirm its status | Palermo | Italy | Completed |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Completed |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Pauls Stradins Clinical University Hospital Coordinator of this site? Confirm its status | Riga | Latvia | Completed |
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Completed |
| Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Uniwersytecki Szpital Kliniczny w Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Completed |
| Hospital Garcia De Orta E.P.E. Coordinator of this site? Confirm its status | Almada | Portugal | Completed |
| Centro Hospitalar E Universitărio de Coimbra E.P.E. Coordinator of this site? Confirm its status | Coimbra | Portugal | Completed |
| Centro Hospitalar Universitario De Lisboa Norte E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Completed |
| Centro Hospitalar Universitário de Santo Antonio,E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Completed |
| Region Vaesterbotten Coordinator of this site? Confirm its status | Umea | Sweden | Completed |
Related publications
- Phase 2b trial of inhaled imatinib for treatment of pulmonary arterial hypertension.Am J Respir Crit Care Med · 2026 · PMID 41738079
This page is information, not medical advice. Discuss any trial with your doctor.