Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2025-12-29 @ 5:56 PM
Study NCT ID:
NCT05036135
Status:
TERMINATED
Last Update Posted:
2024-08-23
First Post:
2021-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH)
Sponsor:
Organization:
Raw JSON
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IMPAHCT: A randomized phase 2b/3 study of inhaled imatinib for pulmonary arterial hypertension. Pulm Circ. 2024 Mar 25;14(1):e12352. doi: 10.1002/pul2.12352. eCollection 2024 Jan.'}, {'pmid': '36923571', 'type': 'DERIVED', 'citation': 'Gillies H, Niven R, Dake BT, Chakinala MM, Feldman JP, Hill NS, Hoeper MM, Humbert M, McLaughlin VV, Kankam M. AV-101, a novel inhaled dry-powder formulation of imatinib, in healthy adult participants: a phase 1 single and multiple ascending dose study. ERJ Open Res. 2023 Mar 13;9(2):00433-2022. doi: 10.1183/23120541.00433-2022. eCollection 2023 Mar.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria\n\n* PAH belonging to one of the subgroups:\n\n 1. I/HPAH, PAH-CTD,\n 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),\n 3. HIV associated or\n 4. PAH due to repaired congenital heart disease (at least 1 year since repair)\n* World Health Organization (WHO) Functional Class II, III or IV symptoms\n* Stable concomitant background therapy of at least one PAH approved medications\n* Able to walk a distance of at least 100 m but no more than 475 m during the Screening 6-minute walk tests.\n\nKey Exclusion Criteria\n\n* Pulmonary hypertension (PH) belonging to Groups 2 to 5\n* A history of left-sided heart disease\n* Pregnant or breast-feeding females\n\nAdditional criteria may apply, per protocol'}, 'identificationModule': {'nctId': 'NCT05036135', 'acronym': 'IMPAHCT', 'briefTitle': 'A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aerovate Therapeutics'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'AV-101-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AV-101 10 mg', 'interventionNames': ['Drug: AV-101']}, {'type': 'EXPERIMENTAL', 'label': 'AV-101 35 mg', 'interventionNames': ['Drug: AV-101']}, {'type': 'EXPERIMENTAL', 'label': 'AV-101 70 mg', 'interventionNames': ['Drug: AV-101']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AV-101', 'type': 'DRUG', 'description': 'AV-101 (imatinib) administered via dry powder inhalation', 'armGroupLabels': ['AV-101 10 mg', 'AV-101 35 mg', 'AV-101 70 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo administered via dry powder inhalation', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Pulmonary 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