Summary

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

Description

Summary

IMPAHCT-FUL: Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (LTE) Trial is a follow up study to establish the long-term safety of AV-101. The long-term effects of AV-101 on efficacy measures will also be assessed. Subjects who successfully complete the 24-week placebo-controlled parent trial (AV-101-002) will be offered the opportunity to continue into this LTE study. Subjects who enroll in the study will receive one of three active AV-101 doses until such time as the optimal dose has been selected in the parent 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)

Keywords

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

Eligibility

You can join if…

Open to people ages 18-75

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.

You CAN'T join if...

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.

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
NCT05557942
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 462 study participants
Last Updated