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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05557942




Registration number
NCT05557942
Ethics application status
Date submitted
15/09/2022
Date registered
28/09/2022
Date last updated
21/06/2024

Titles & IDs
Public title
Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (IMPAHCT-FUL)
Scientific title
A Long-Term Extension, Multi-Center Safety Study of AV-101 in Subjects With Pulmonary Arterial Hypertension (PAH) Who Have Completed Study AV-101-002 (IMPAHCT-FUL)
Secondary ID [1] 0 0
AV-101-003
Universal Trial Number (UTN)
Trial acronym
IMPAHCT-FUL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AV-101

Experimental: low dose AV-101 -

Experimental: medium dose AV-101 -

Experimental: high dose AV-101 -


Treatment: Drugs: AV-101
AV-101 (imatinib) administered via dry powder inhalation
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability of AV-101
Timepoint [1] 0 0
Through Study completion, anticipated to be approximately 3 years

Eligibility
Key inclusion criteria
Key

To be eligible, a participant is required to be or have:

* Consented to participate in the LTE and has successfully completed the placebo-controlled 24-week Study AV-101-002.

Key
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects meeting any of the following criteria:

* The Investigator believes that it would not be in the best interest of the subject to be included in the LTE e.g., for clinical or social reasons.
* Subjects who were not compliant with study medication in AV-101-002 as assessed by the Investigator.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
462
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [3] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4575 - Birtinya
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
Argentina
State/province [13] 0 0
Buenos Aires
Country [14] 0 0
Argentina
State/province [14] 0 0
Córdoba
Country [15] 0 0
Argentina
State/province [15] 0 0
Santa Fe
Country [16] 0 0
Belgium
State/province [16] 0 0
Bruxelles
Country [17] 0 0
Belgium
State/province [17] 0 0
Leuven
Country [18] 0 0
Canada
State/province [18] 0 0
Alberta
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Canada
State/province [20] 0 0
Quebec
Country [21] 0 0
Chile
State/province [21] 0 0
Santiago
Country [22] 0 0
China
State/province [22] 0 0
Beijing
Country [23] 0 0
China
State/province [23] 0 0
Chongqing
Country [24] 0 0
China
State/province [24] 0 0
Guangdong
Country [25] 0 0
China
State/province [25] 0 0
Hunan
Country [26] 0 0
China
State/province [26] 0 0
Kunming
Country [27] 0 0
China
State/province [27] 0 0
Lanzhou
Country [28] 0 0
China
State/province [28] 0 0
Nanjing
Country [29] 0 0
China
State/province [29] 0 0
Tianjin
Country [30] 0 0
Colombia
State/province [30] 0 0
Floridablanca
Country [31] 0 0
France
State/province [31] 0 0
Le Kremlin-Bicêtre
Country [32] 0 0
France
State/province [32] 0 0
Montpellier
Country [33] 0 0
France
State/province [33] 0 0
Strasbourg
Country [34] 0 0
Germany
State/province [34] 0 0
Dresden
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Germany
State/province [35] 0 0
Gießen
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Germany
State/province [36] 0 0
Heidelberg
Country [37] 0 0
Israel
State/province [37] 0 0
Jerusalem
Country [38] 0 0
Italy
State/province [38] 0 0
Foggia
Country [39] 0 0
Italy
State/province [39] 0 0
Milan
Country [40] 0 0
Italy
State/province [40] 0 0
Monza
Country [41] 0 0
Italy
State/province [41] 0 0
Palermo
Country [42] 0 0
Italy
State/province [42] 0 0
Pavia
Country [43] 0 0
Italy
State/province [43] 0 0
Rome
Country [44] 0 0
Latvia
State/province [44] 0 0
Riga
Country [45] 0 0
Mexico
State/province [45] 0 0
Jalisco
Country [46] 0 0
Mexico
State/province [46] 0 0
Nuevo León
Country [47] 0 0
Poland
State/province [47] 0 0
Kraków
Country [48] 0 0
Poland
State/province [48] 0 0
Poznan
Country [49] 0 0
Poland
State/province [49] 0 0
Lódz
Country [50] 0 0
Portugal
State/province [50] 0 0
Almada
Country [51] 0 0
Portugal
State/province [51] 0 0
Lisboa
Country [52] 0 0
Singapore
State/province [52] 0 0
Singapore
Country [53] 0 0
South Africa
State/province [53] 0 0
Johannesburg
Country [54] 0 0
Spain
State/province [54] 0 0
Barcelona
Country [55] 0 0
Spain
State/province [55] 0 0
Las Palmas De Gran Canaria
Country [56] 0 0
Spain
State/province [56] 0 0
Madrid
Country [57] 0 0
Spain
State/province [57] 0 0
Málaga
Country [58] 0 0
Spain
State/province [58] 0 0
Salamanca
Country [59] 0 0
Spain
State/province [59] 0 0
Santander
Country [60] 0 0
Spain
State/province [60] 0 0
Toledo
Country [61] 0 0
United Kingdom
State/province [61] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Aerovate Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
IMPAHCT-FUL: Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (LTE) Trial is a follow up study to establish the long-term safety of AV-101. The long-term effects of AV-101 on efficacy measures will also be assessed. Subjects who successfully complete the 24-week placebo-controlled parent trial (AV-101-002) will be offered the opportunity to continue into this LTE study. Subjects who enroll in the study will receive one of three active AV-101 doses until such time as the optimal dose has been selected in the parent study.
Trial website
https://clinicaltrials.gov/study/NCT05557942
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
(888) 373-8110
Fax 0 0
Email 0 0
clinicaltrials@aerovatetx.com
Contact person for scientific queries