Tan Tock Seng Hospital | Clinical Research and Innovation Office
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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.
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Inclusion and exclusion criteria
Key Inclusion Criteria
PAH belonging to one of the subgroups:
World Health Organization (WHO) Functional Class II, III or IV symptoms
Stable concomitant background therapy of at least one 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.
Key Exclusion Criteria
Additional criteria may apply, per protocol
Primary purpose
Allocation
Interventional model
Masking
202 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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