What side effects are associated with this type of intervention?

Common treatments for Pulmonary Arterial Hypertension (PAH) include tyrosine kinase inhibitors like imatinib, endothelin receptor antagonists (ERAs) such as bosentan, ambrisentan, and macitentan, phosphodiesterase-5 inhibitors (PDE5Is) like sildenafil and tadalafil, and prostacyclin analogues such as epoprostenol and iloprost. Known side effects of these treatments can include hepatotoxicity, anemia, headache, peripheral edema, gastrointestinal issues, systemic hypotension, and potential cardiovascular events. Inhaled therapies, while targeting the lung vasculature, may also cause local irritation and require proper inhalation techniques for efficacy.

What prior FDA approvals exist?

The FDA has approved several treatments for Pulmonary Arterial Hypertension (PAH). Notably, tyrosine kinase inhibitors like imatinib have been explored, although not yet approved specifically for PAH. Other approved treatments include endothelin receptor antagonists such as bosentan and macitentan, phosphodiesterase-5 inhibitors like sildenafil and tadalafil, and prostanoids including epoprostenol and treprostinil. These therapies target different pathways to reduce pulmonary vascular resistance and improve symptoms in PAH patients.

What other types of research exist?

Promising novel alternatives to AV-101 for PAH patients include sotatercept, a fusion protein targeting the TGF-beta superfamily, which has shown positive results in clinical trials. Additionally, ralinepag, an oral prostacyclin receptor agonist, and selexipag, another oral prostacyclin receptor agonist, are emerging as effective treatments. These alternatives have demonstrated potential in improving hemodynamics and clinical outcomes in PAH patients.

← Back to Search

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

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing the safety and effectiveness of AV-101, an inhaled medication, in patients with Pulmonary Arterial Hypertension. The medication aims to reduce high blood pressure in the lung arteries.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, anticipated to be approximately 3 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Treatment-emergent Adverse Events

Other study objectives

Time to Clinical Worsening

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Placebo Crossover AV-101 70 mgExperimental Treatment1 Intervention

Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.

Group II: Placebo Crossover AV-101 35 mgExperimental Treatment1 Intervention

Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.

Group III: Placebo Crossover AV-101 10 mgExperimental Treatment1 Intervention

Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 10 milligrams (mg) administered twice daily (BID) via dry powder inhalation.

Group IV: Continuing AV-101 70 mgExperimental Treatment1 Intervention

Participants who previously received AV-101 70 mg in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.

Group V: Continuing AV-101 35 mgExperimental Treatment1 Intervention

Participants who previously received AV-101 35 mg in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.

Group VI: Continuing AV-101 10 mgExperimental Treatment1 Intervention

Participants who previously received AV-101 10 mg in AV-101-002 received AV-101 (imatinib) 10 mg administered BID via dry powder inhalation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AV-101

2018

Completed Phase 2

~230

Do I qualify?Apply below to find out

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.