NCT05557942CompletedPhase 3
Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial – Follow Up Long Term Extension (IMPAHCT-FUL)
IMPAHCT-FUL: 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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 3 Jun 2024
Brief summary (registry, in English)
The primary objective of the study is to establish the long-term safety of AV-101. The long-term effects of AV-101 on efficacy measures (e.g., 6MWD, NT-proBNP, cardiac echo) will also be assessed.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 205 (actual)
- First submitted
- 10 Feb 2024
- Start date
- 5 May 2023
- Lead sponsor
- Aerovate Therapeutics Inc.
- NCT number
- NCT05557942
- EU CT number
- 2023-508735-31-00
- EudraCT number
- 2021-006864-25
What you commit to
- Study type: Interventional · Phase 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.
Prior treatment
- Subjects who were not compliant with study medication in AV-101-002 as assessed by the Investigator.
Other
- 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.
Who the study is looking for
- Consented to participate in the LTE and has successfully completed the placebo-controlled 24-week Study AV-101-002.
- Female subjects of childbearing potential who have agreed to continue to use a highly effective form of contraception during the LTE and for at least 30 days after completing or discontinuing study treatment.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (46)
Sites in registry order. Save your city in your profile 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 Universitaet 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 La Paz 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 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 |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Le Kremlin-Bicetre | France | Completed |
| Centre Hospitalier Regional 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 Stichting 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 |
| Unidade Local de Saúde 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 |
This page is information, not medical advice. Discuss any trial with your doctor.