NCT05557942

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

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)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: Aerovate Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

IMPAHCT-FUL: Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (LTE) Trial was a follow up study to establish the long-term safety of AV-101. Subjects who successfully completed the 24-week placebo-controlled parent trial (AV-101-002, NCT#05036135) were offered the opportunity to continue into this LTE study. Subjects who enrolled in the study were to receive one of three active AV-101 doses until such time as the optimal dose was selected in the parent study.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	AV-101	AV-101 (imatinib) administered via dry powder inhalation

Timeline

• Start date: 2022-11-02
• Primary completion: 2024-08-08
• Completion: 2024-08-08
• First posted: 2022-09-28
• Last updated: 2024-10-10
• Results posted: 2024-10-10

Locations

72 sites across 20 countries: United States, Argentina, Australia, Belgium, Canada, Chile, China, Colombia, France, Germany, Israel, Italy, Latvia, Mexico, Poland, Portugal, Singapore, South Africa, Spain, United Kingdom

Regulatory

• FDA-regulated drug study