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Inhaled Imatinib for Pulmonary Arterial Hypertension (IMPAHCT-FUL Trial)

Phase 3
Waitlist Available
Research Sponsored by Aerovate Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, anticipated to be approximately 3 years
Awards & highlights

Summary

This trial will study the long-term safety and effectiveness of a medicine, AV-101, for pulmonary arterial hypertension. Subjects will receive one of three doses until the optimal dose is found.

Who is the study for?
This trial is for people who have completed the initial 24-week study of AV-101 for Pulmonary Arterial Hypertension. They must consent to continue and be deemed suitable by the investigator, without social or clinical reasons that may interfere with their participation.Check my eligibility
What is being tested?
The IMPAHCT-FUL trial is testing long-term safety and effectiveness of different doses of an inhaled medication called AV-101 for treating Pulmonary Arterial Hypertension. Participants will receive one of three active doses determined optimal from a previous study.See study design
What are the potential side effects?
While specific side effects are not listed here, they could include typical reactions to pulmonary hypertension medications such as cough, headache, dizziness, nausea or potential respiratory issues due to inhalation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, anticipated to be approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, anticipated to be approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability of AV-101
Other outcome measures
Change from baseline in NT-proBNP
Echocardiography
Change from baseline in the 6MWD
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: medium dose AV-101Experimental Treatment1 Intervention
Group II: low dose AV-101Experimental Treatment1 Intervention
Group III: high dose AV-101Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AV-101
2018
Completed Phase 2
~230

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Pulmonary Arterial Hypertension (PAH) work by targeting different pathways to reduce pulmonary vascular resistance and improve blood flow. Tyrosine Kinase Inhibitors (TKIs) like Imatinib inhibit growth factor receptors, reducing vascular remodeling and proliferation. Phosphodiesterase type 5 inhibitors (PDE5Is) such as Sildenafil and Tadalafil increase cyclic GMP levels, leading to vasodilation and improved exercise capacity. Endothelin Receptor Antagonists (ERAs) like Bosentan block endothelin-1, a potent vasoconstrictor, thereby reducing blood pressure in the lungs. Prostacyclin Analogues such as Epoprostenol mimic prostacyclin, promoting vasodilation and inhibiting platelet aggregation. These mechanisms are crucial for PAH patients as they help alleviate symptoms, improve quality of life, and potentially slow disease progression.
Imatinib is partially effective for the treatment of pulmonary capillary hemangiomatosis.

Find a Location

Who is running the clinical trial?

Aerovate TherapeuticsLead Sponsor
1 Previous Clinical Trials
462 Total Patients Enrolled
1 Trials studying Pulmonary Arterial Hypertension
462 Patients Enrolled for Pulmonary Arterial Hypertension

Media Library

high dose AV-101 Clinical Trial Eligibility Overview. Trial Name: NCT05557942 — Phase 3
Pulmonary Arterial Hypertension Research Study Groups: high dose AV-101, low dose AV-101, medium dose AV-101
Pulmonary Arterial Hypertension Clinical Trial 2023: high dose AV-101 Highlights & Side Effects. Trial Name: NCT05557942 — Phase 3
high dose AV-101 2023 Treatment Timeline for Medical Study. Trial Name: NCT05557942 — Phase 3
~212 spots leftby Dec 2025