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

a study on High Blood Pressure Pulmonary Arterial Hypertension Pulmonary Hypertension

Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Marc Simon, MD
Headshot of Marc Simon
Marc Simon

Description

Summary

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.

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)

Keywords

Pulmonary Arterial Hypertension, Lungs, Pulmonary, PAH, AV-101, imatinib, IMPAHCT, Familial Primary Pulmonary Hypertension, Hypertension

Eligibility

You can join if…

Open to people ages 18-75

  • PAH belonging to one of the subgroups:
    1. I/HPAH, PAH-CTD,
    2. 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),
    3. HIV associated or
    4. PAH due to repaired congenital heart disease (at least 1 year since repair)
  • World Health Organization (WHO) Functional Class II, III or IV symptoms
  • Stable concomitant background therapy of at least two PAH approved medications
  • Able to walk a distance of at least 100 m but no more than 475 m during the Screening 6-minute walk tests.

You CAN'T join if...

  • Pulmonary hypertension (PH) belonging to Groups 2 to 5
  • A history of left-sided heart disease

  • Pregnant or breast-feeding females

    Additional criteria may apply, per protocol

Locations

  • University of California accepting new patients
    San Francisco California 94143 United States
  • UC Davis Medical Center accepting new patients
    Sacramento California 95817 United States

Lead Scientist at UCSF

  • Marc Simon, MD
    Dr. Simon is director of Pulmonary Vascular Disease and the Pulmonary Hypertension Comprehensive Care Center. He has expertise as a cardiologist specializing in pulmonary hypertension, advanced heart failure, and heart transplantation.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Aerovate Therapeutics
ID
NCT05036135
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 462 study participants
Last Updated
Contact us about this trial