A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH)
Stopped early · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Pulmonary Arterial Hypertension
In brief
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.
Key facts
- Study ID
- NCT05036135
- Run by
- Aerovate Therapeutics
- People needed
- 202
- Starts
- 2021-12-02
- Expected to finish
- 2024-08-09
- Last updated by the study team
- 2024-08-23
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Arizona, Department of Medicine — Tucson, Arizona, United States
- UCLA/David Geffen School of Medicine-Pulmonary and Criticial Care — Los Angeles, California, United States
- Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
- Cedars-Sinai Medical Center, Pulmonary & Critical Care — Los Angeles, California, United States
- Dept of Veterans Affairs Greater Los Angeles Healthcare System — Los Angeles, California, United States
- UC Davis Medical Center — Sacramento, California, United States
- University of California — San Francisco, California, United States
- LA Biomedical Research Institute Harbor — Torrance, California, United States
- University of Colorado Denver — Aurora, Colorado, United States
- National Jewish Health — Denver, Colorado, United States
- George Washington University Medical Faculty Associates, Inc. — Washington D.C., District of Columbia, United States
- Mayo Clinic Florida — Jacksonville, Florida, United States
- Orlando Heart Center — Orlando, Florida, United States
- Emory University — Atlanta, Georgia, United States
- Indiana University Health — Indianapolis, Indiana, United States
- University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- Tufts Medical Center, Inc. — Boston, Massachusetts, United States
- University of Michigan — Ann Arbor, Michigan, United States
- University of Minnesota — Minneapolis, Minnesota, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- University of Nebraska Medical Center- Hematology/Oncology Section — Omaha, Nebraska, United States
- The Unviersity of New Mexico - UNM Hospitals — Albuquerque, New Mexico, United States
- New York-Presbyterian Brooklyn Methodist Hospital — Brooklyn, New York, United States
- Arizona Pulmonary Specialists, Ltd. — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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