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

  • STATUS
    Recruiting
  • End date
    Jan 28, 2025
  • participants needed
    462
  • sponsor
    Aerovate Therapeutics
Updated on 28 May 2022

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.

Details
Condition Pulmonary Arterial Hypertension
Treatment Placebo, AV-101
Clinical Study IdentifierNCT05036135
SponsorAerovate Therapeutics
Last Modified on28 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

PAH belonging to one of the subgroups
I/HPAH, PAH-CTD
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)
HIV associated or
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

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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