Pulmonary Arterial HypertensionPhase 3IMPAHCT-FULNCT05557942
Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (IMPAHCT-FUL)
A Phase 3 study testing AV-101 in people with Pulmonary Arterial Hypertension, run by Aerovate Therapeutics at 72 sites in 20 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- AV-101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 72 sitesin 20 countries
- Study dates
- 2 Nov 2022to 8 Aug 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
72 sites in 20 countries.
72 sites in 20 countries
United States16 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30322
Tufts Medical Center, Inc.
Boston, Massachusetts, 02111
Ohio State University
Columbus, Ohio, 43210
Indiana University Health
Indianapolis, Indiana, 46202
Mayo Clinic Florida
Jacksonville, Florida, 32224
UCLA/David Geffen School of Medicine-Pulmonary and Criticial Care
Los Angeles, California, 90024
Kaiser Permanente - Los Angeles Medical Center
Los Angeles, California, 90027
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Arizona Pulmonary Specialist. LTD.
Phoenix, Arizona, 85012
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
UC Davis Medical Center
Sacramento, California, 95817
University of California
San Francisco, California, 94143
Washington University School of Medicine
St Louis, Missouri, 63110
University of Arizona, Department of Medicine
Tucson, Arizona, 85724
GW Medical Faculty Associates
Washington D.C., District of Columbia, 20037
China8 sites
Peking Union Medical College Hospital
Beijing, 100730
Chongqing Medical University - The First Affiliated Hospital
Chongqing, 40016
Guangdong Provincial People's Hospital
Guangdong, 510000
Central South University - The Second Xiangya Hospital
Hunan, 410011
Yanan Hospital of Kunming City
Kunming, 650051
Gansu Provincial People's Hospital
Lanzhou, 730000
Southeast University (SEU) - Zhongda Hospital
Nanjing, 210009
Tianjin Medical University General Hospital
Tianjin, 300052
Spain7 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hosp. Universitario Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, 35010
Hospital 12 de Octubre
Madrid, 28014
Hospital Universitario Virgen de la Victoria
Málaga, 29071
Hospital universtario de Salamanca
Salamanca, 37007
Hosp. Universitario Marques de Valdecilla
Santander, 39003
Hospital Universitario de Toledo
Toledo, 45007
Italy6 sites
Azienda Ospedaliero Universitaria Ospedali Riuniti - Foggia
Foggia, 71122
Ospedale San Giuseppe - Fatebenefratelli
Milan, 20123
Fondazione IRCCS San Gerardo Dei Tintori
Monza, 20900
Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione
Palermo, 90127
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Azienda Ospedaliera Universitaria Policlinico Umberto I
Rome, 137
Argentina5 sites
Cardiologia Palmero
Buenos Aires, 1425
Nexo Salud Investigación Clínica
Buenos Aires, 1425
Sanatorio de la Trinidad Mitre
Buenos Aires, C1039AAO
Insituto Medico DAMIC
Córdoba, 5009
Hospital Dr. Jose Maria Cullen
Santa Fe, S3000EOZ
Australia4 sites
Sunshine Coast University Hospital
Birtinya, Queensland, 4575
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
The Prince Charles Hospital
Chermside, Queensland, 4032
The Alfred Hospital
Melbourne, Victoria, 3004
Canada3 sites
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
London Health Science Centre
London, Ontario, N6A 5W9
Jewish General Hospital
Montreal, Quebec, H3T 1E2
France3 sites
Groupement Hospitalier Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, 94275
Hopital Arnaud de Villeneuve
Montpellier, 34295
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Germany3 sites
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, 1307
Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen
Giessen, 35392
Universitaetsklinikum Heidelberg
Heidelberg, 69126
Poland3 sites
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Krakow, 31-202
Wojewódzki Specjalistyczny Szpital im. Dr. Wł. Biegańskiego w Łodzi
Lodz, 91-347
Szpital Kliniczny Przemienienia Pańskiego UM im. Marcinkowskiego
Poznan, 61-848
Belgium2 sites
Cliniques Universitaires de Bruxelles Hopital Erasme
Brussels, 1070
UZ Leuven
Leuven, 3000
Mexico2 sites
CICUM San Miguel
Guadalajara, Jalisco, 44160
Unidad de Investigacion Clinica en Medicina S.C.
Monterrey, Nuevo León, 64718
Portugal2 sites
Hospital Garcia de Orta, EPE
Almada, 2805-267
Hospital Pulido Valente
Lisbon, 1769-001
Singapore2 sites
National University Hospital
Singapore, 119074
Tan Tock Seng Hospital
Singapore, 308433
Chile1 site
Centro de Investigaciones Clinicas de la Universidad Catolica
Santiago, 8330024
South Africa1 site
Center of Chest Disease Johannesburg
Johannesburg, 2193
United Kingdom1 site
Imperial College Healthcare NHS Trust
London, W12 0HS
About this study
Official title: 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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- AV-101
- Keywords
- Pulmonary Arterial Hypertension, Lungs, Pulmonary, PAH, AV-101, imatinib, IMPAHCT, IMPAHCT-FUL
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AV-101Drug
AV-101 (imatinib) administered via dry powder inhalation
| Study group | Role | What they receive |
|---|---|---|
| Placebo Crossover AV-101 10 mg | Experimental | Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 10 milligrams (mg) administered twice daily (BID) via dry powder inhalation. Receives: Drug: AV-101 |
| Placebo Crossover AV-101 35 mg | Experimental | Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation. Receives: Drug: AV-101 |
| Placebo Crossover AV-101 70 mg | Experimental | Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation. Receives: Drug: AV-101 |
| Continuing AV-101 10 mg | Experimental | Participants who previously received AV-101 10 mg in AV-101-002 received AV-101 (imatinib) 10 mg administered BID via dry powder inhalation. Receives: Drug: AV-101 |
| Continuing AV-101 35 mg | Experimental | Participants who previously received AV-101 35 mg in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation. Receives: Drug: AV-101 |
| Continuing AV-101 70 mg | Experimental | Participants who previously received AV-101 70 mg in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation. Receives: Drug: AV-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events
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.
Measured: From date of first dose to 30 days after date of last dose (up to approximately 21 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start2 Nov 2022
- Primary completion8 Aug 2024
- Study completion8 Aug 2024
Why it stopped: Results from the parent study (IMPAHCT) demonstrated that while inhaled imatinib was well tolerated, it did not prove to be efficacious at any of the doses of AV-101 evaluated in the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerovate Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557942
- Sponsor's protocol ID
- AV-101-003
- Acronym
- IMPAHCT-FUL
- Status last verified
- Oct 2024
- First submitted
- 15 Sep 2022
- Last updated
- 10 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05557942
- Acronym / sponsor ID
- IMPAHCT-FUL / AV-101-003
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Pulmonary Arterial Hypertension, Lungs, Pulmonary, PAH, AV-101, imatinib, IMPAHCT, IMPAHCT-FUL
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Results from the parent study (IMPAHCT) demonstrated that while inhaled imatinib was well tolerated, it did not prove to be efficacious at any of the doses of AV-101 evaluated in the study.
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Aerovate TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 8 Aug 2024 (actual)
- Study completion
- 8 Aug 2024 (actual)
- First posted
- 28 Sep 2022 (actual)
- Results
- Posted 10 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo Crossover AV-101 10 mg | Experimental | Drug: AV-101Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 10 milligrams (mg) administered twice daily (BID) via dry powder inhalation. |
| Placebo Crossover AV-101 35 mg | Experimental | Drug: AV-101Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation. |
| Placebo Crossover AV-101 70 mg | Experimental | Drug: AV-101Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation. |
| Continuing AV-101 10 mg | Experimental | Drug: AV-101Participants who previously received AV-101 10 mg in AV-101-002 received AV-101 (imatinib) 10 mg administered BID via dry powder inhalation. |
| Continuing AV-101 35 mg | Experimental | Drug: AV-101Participants who previously received AV-101 35 mg in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation. |
| Continuing AV-101 70 mg | Experimental | Drug: AV-101Participants who previously received AV-101 70 mg in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Consented to participate in the LTE and has successfully completed the placebo-controlled 24-week Study AV-101-002.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AV-101AV-101 (imatinib) administered via dry powder inhalation | Drug | Continuing AV-101 10 mg, Continuing AV-101 35 mg, Continuing AV-101 70 mg, Placebo Crossover AV-101 10 mg, Placebo Crossover AV-101 35 mg, Placebo Crossover AV-101 70 mg |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
72 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AV-101 in people with Pulmonary Arterial Hypertension, run by Aerovate Therapeutics at 72 sites in 20 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in United States, China, Spain, Italy, Argentina and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.