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Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (IMPAHCT-FUL) (IMPAHCT-FUL)

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ClinicalTrials.gov Identifier: NCT05557942
Recruitment Status : Recruiting
First Posted : September 28, 2022
Last Update Posted : December 7, 2022
Sponsor:
Information provided by (Responsible Party):
Aerovate Therapeutics

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: AV-101 Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 462 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : November 2, 2022
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: low dose AV-101 Drug: AV-101
AV-101 (imatinib) administered via dry powder inhalation
Experimental: medium dose AV-101 Drug: AV-101
AV-101 (imatinib) administered via dry powder inhalation
Experimental: high dose AV-101 Drug: AV-101
AV-101 (imatinib) administered via dry powder inhalation


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability of AV-101 [ Time Frame: Through Study completion, anticipated to be approximately 3 years ]
    as measured by Incidence of Adverse Events


Other Outcome Measures:
  1. Change from baseline in the 6MWD [ Time Frame: Baseline, weeks 4,12 and 24, and every 12 weeks up to study completion ]
  2. Change from baseline in NT-proBNP [ Time Frame: Baseline, weeks 4,12 and 24, and every 12 weeks up to study completion ]
  3. Change from baseline in Right Ventricular (RV) function (e.g. TAPSE, RVFAC, RV/PA coupling, TRJV etc.) as measured by Resting Transthoracic Echocardiography [ Time Frame: Baseline, week 24, and every 12 weeks up to study completion ]
  4. Time to Clinical Worsening [ Time Frame: Through Study completion, anticipated to be approximately 3 years ]

    Clinical Worsening Events will be defined as:

    • Death (all causes)
    • Hospitalization for worsening PAH
    • Initiation of parenteral prostanoids (subcutaneous or intravenous infusion)
    • ≥ 15% decline from baseline in 6MWD accompanied with continued or worsening to WHO FC III or IV symptoms. The decline in 6MWD must be confirmed with a repeat test on a different day within 2 weeks Time to clinical worsening is the number of days between the earliest occurrence of the clinical worsening component and the date of the first dose in the parent trial.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

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 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05557942


Contacts
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Contact: Toll Free Number (888) 373-8110 clinicaltrials@aerovatetx.com

Locations
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United States, Indiana
Indiana University Health Recruiting
Indianapolis, Indiana, United States, 46202
Principal Investigator: Roberto Machado, MD         
Sponsors and Collaborators
Aerovate Therapeutics
More Information
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Responsible Party: Aerovate Therapeutics
ClinicalTrials.gov Identifier: NCT05557942    
Other Study ID Numbers: AV-101-003
First Posted: September 28, 2022    Key Record Dates
Last Update Posted: December 7, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aerovate Therapeutics:
Pulmonary Arterial Hypertension
Lungs
Pulmonary
PAH
 AV-101
imatinib
IMPAHCT
IMPAHCT-FUL
Additional relevant MeSH terms:
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Pulmonary Arterial Hypertension
Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases