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

R
Roberto Machado, MD

Primary Investigator

Administratively Closed
18 years - 75 years
All
Phase 2/3
462 participants needed
1 Location

Brief description of study

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) inwith Pulmonary Arterial Hypertension (PAH). The Phase 2b part of the study willhree 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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pulmonary Arterial Hypertension
  • Age: 18 years - 75 years
  • Gender: All

Key Inclusion Criteria
  • 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 thevestigator for at least one year with no relapses of drug or toxin/chemicalbuse),
    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 Screening6-minute walk tests.
Key Exclusion Criteria
  • 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

Updated on 01 Aug 2024. Study ID: AV-101-002, ECRO-AEROVATE-IMPAHCT, 12330

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