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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05036135
Registration number
NCT05036135
Ethics application status
Date submitted
16/08/2021
Date registered
5/09/2021
Date last updated
21/06/2024
Titles & IDs
Public title
A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH)
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Scientific title
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)
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Secondary ID [1]
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AV-101-002
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Universal Trial Number (UTN)
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Trial acronym
IMPAHCT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Human Genetics and Inherited Disorders
0
0
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0
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Other human genetics and inherited disorders
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Cardiovascular
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0
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0
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AV-101
Treatment: Drugs - Placebo
Experimental: Phase 2b low dose AV-101 -
Experimental: Phase 2b medium dose AV-101 -
Experimental: Phase 2b high dose AV-101 -
Placebo comparator: Phase 2b Placebo -
Experimental: Phase 3 dose AV-101 (Optimal dose selected in Phase 2b) -
Placebo comparator: Phase 3 Placebo -
Treatment: Drugs: AV-101
AV-101 (imatinib) administered via dry powder inhalation
Treatment: Drugs: Placebo
Placebo administered via dry powder inhalation
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Phase 2b: Change from Baseline in Pulmonary Vascular Resistance (PVR)
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Assessment method [1]
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Timepoint [1]
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24 weeks
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Primary outcome [2]
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Phase 3: Change from Baseline in Six Minute Walk Distance (6MWD)
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Assessment method [2]
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Timepoint [2]
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24 weeks
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Secondary outcome [1]
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Phase 2b: Change from Baseline in N-terminal pro B-type natriuretic peptide (NT-proBNP)
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Assessment method [1]
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Timepoint [1]
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24 weeks
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Secondary outcome [2]
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Phase 2b: Change from Baseline in Six Minute Walk Distance (6MWD)
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Assessment method [2]
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0
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Timepoint [2]
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24 weeks
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Secondary outcome [3]
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Phase 2b: Time to Clinical Worsening
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Assessment method [3]
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Timepoint [3]
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24 weeks
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Secondary outcome [4]
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Phase 2b: Proportion of Subjects with Improvement in WHO Functional Class
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Assessment method [4]
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Timepoint [4]
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24 weeks
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Secondary outcome [5]
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Phase 2b: Change from Baseline in Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2.0 Risk Score
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Assessment method [5]
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REVEAL Lite 2.0 risk scores range from 1 to 14; a higher score represents higher risk
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Timepoint [5]
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24 weeks
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Secondary outcome [6]
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Phase 2b: Change from Baseline in Health-Related Quality of Life emPHasis-10 Questionnaire Score
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Assessment method [6]
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emPHasis-10 questionnaire scores range from 0 - 50; a higher score represents a higher symptom burden
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Timepoint [6]
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24 weeks
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Secondary outcome [7]
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Phase 3: Change from Baseline in NT-proBNP
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Assessment method [7]
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Timepoint [7]
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24 weeks
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Secondary outcome [8]
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Phase 3: Time to Clinical Worsening
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Assessment method [8]
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Timepoint [8]
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24 weeks
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Secondary outcome [9]
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Phase 3: Proportion of Subjects with Improvement in WHO Functional Class
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Assessment method [9]
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Timepoint [9]
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24 weeks
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Secondary outcome [10]
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Phase 3: Change from Baseline in Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2.0 Risk Score
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Assessment method [10]
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REVEAL Lite 2.0 risk scores range from 1 to 14; a higher score represents higher risk
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Timepoint [10]
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24 weeks
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Secondary outcome [11]
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Phase 3: Change from Baseline in Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Questionnaire Score
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Assessment method [11]
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PAH-SYMPACT is a patient reported outcome instrument developed to assess PAH symptoms and impacts
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Timepoint [11]
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24 weeks
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Eligibility
Key inclusion criteria
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 the investigator for at least one year with no relapses of drug or toxin/chemical abuse),
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 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.
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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The people analysing the results/data
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Intervention assignment
Parallel
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Phase
Phase 2
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/12/2021
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Date of last participant enrolment
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Actual
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Date of last data collection
Anticipated
1/01/2025
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Actual
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Sample size
Target
462
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Royal Prince Alfred Hospital - Camperdown
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Concord Repatriation General Hospital - Concord West
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Nepean Hospital - Kingswood
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Westmead Hospital - Westmead
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Sunshine Coast University Hospital - Birtinya
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The Prince Charles Hospital - Chermside
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The Alfred Hospital - Melbourne
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Royal Adelaide Hospital - Adelaide
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Fiona Stanley Hospital - Murdoch
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2050 - Camperdown
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2138 - Concord West
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2747 - Kingswood
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2145 - Westmead
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4575 - Birtinya
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4032 - Chermside
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3004 - Melbourne
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5000 - Adelaide
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6150 - Murdoch
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Newcastle
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Aerovate Therapeutics
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT05036135
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Contacts
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(888) 373-8110
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/study/NCT05036135
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