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Terminated Phase 2Phase 3 Interventional

A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH)

ClinicalTrials.gov ID: NCT05036135

Public ClinicalTrials.gov record NCT05036135. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 2:09 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

IMPAHCT: Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial is a Phase 2b/Phase 3 study to evaluate the safety and efficacy of AV-101 (dry powder inhaled imatinib) in patients with Pulmonary Arterial Hypertension (PAH). The Phase 2b part of the study will assess three doses to establish an optimal dose for the Phase 3 part of the study. The Phase 2b primary endpoint will be the placebo corrected change in pulmonary vascular resistance (PVR). The Phase 3 primary endpoint will be the placebo corrected change in 6-minute walk distance (6MWD) after 24 weeks of treatment.

Study identification

NCT ID
NCT05036135
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 2, Phase 3
Lead sponsor
Aerovate Therapeutics
Industry
Enrollment
202 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 1, 2021
Primary completion
Aug 8, 2024
Completion
Aug 8, 2024
Last update posted
Aug 22, 2024

2021 – 2024

United States locations

U.S. sites
39
U.S. states
23
U.S. cities
34
Facility City State ZIP Site status
Arizona Pulmonary Specialists, Ltd. Phoenix Arizona 85012
University of Arizona, Department of Medicine Tucson Arizona 85724
UCLA/David Geffen School of Medicine-Pulmonary and Criticial Care Los Angeles California 90024
Kaiser Permanente Los Angeles Medical Center Los Angeles California 90027
Cedars-Sinai Medical Center, Pulmonary & Critical Care Los Angeles California 90048
Dept of Veterans Affairs Greater Los Angeles Healthcare System Los Angeles California 90073
UC Davis Medical Center Sacramento California 95817
University of California San Francisco California 94143
LA Biomedical Research Institute Harbor Torrance California 90509
University of Colorado Denver Aurora Colorado 80045
National Jewish Health Denver Colorado 80206
George Washington University Medical Faculty Associates, Inc. Washington D.C. District of Columbia 20073
Mayo Clinic Florida Jacksonville Florida 32224
Orlando Heart Center Orlando Florida 32804
Emory University Atlanta Georgia 30322
Indiana University Health Indianapolis Indiana 46202
University of Iowa Hospitals & Clinics Iowa City Iowa 52242
University of Kansas Medical Center Kansas City Kansas 66160
Tufts Medical Center, Inc. Boston Massachusetts 02111
University of Michigan Ann Arbor Michigan 48109
University of Minnesota Minneapolis Minnesota 55455
Washington University School of Medicine St Louis Missouri 63110
University of Nebraska Medical Center- Hematology/Oncology Section Omaha Nebraska 68198
The Unviersity of New Mexico - UNM Hospitals Albuquerque New Mexico 87131
New York-Presbyterian Brooklyn Methodist Hospital Brooklyn New York 11215
NYU Langone Seaport New York New York 10016
Duke University Medical Center - Duke South Clinic Durham North Carolina 27710
The Lindner Center for Research and Education Cincinnati Ohio 45219
University of Cincinnati Cincinnati Ohio 45267
The Ohio State University Wexner Medical Center Columbus Ohio 43210
Bend Memorial Clinic Oregon City Oregon 97701
Hospital of the University of Pennsylvania Philadelphia Pennsylvania 19104
Thomas Jefferson University Philadelphia Pennsylvania 19107
UPMC Presbyterian Hospital Pittsburgh Pennsylvania 15213
Stat Care Pulmonary Consultants, PLLC Knoxville Tennessee 37919
Vanderbilt University Medical Center Nashville Tennessee 37232
Baylor University Medical Center Dallas Texas 75246
Houston Methodist Hospital Houston Texas 77030
Sentara Medical Group - Sentara Pulmonary & Critical Care Specialists Norfolk Virginia 23507

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 89 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05036135, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 22, 2024 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05036135 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →