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

Phase 3

Terminated

Brief 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Placebo Crossover AV-101 10 mg	AV-101	Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 10 milligrams (mg) administered twice daily (BID) via dry powder inhalation.
Placebo Crossover AV-101 35 mg	AV-101	Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.
Placebo Crossover AV-101 70 mg	AV-101	Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.
Continuing AV-101 10 mg	AV-101	Participants who previously received AV-101 10 mg in AV-101-002 received AV-101 (imatinib) 10 mg administered BID via dry powder inhalation.
Continuing AV-101 35 mg	AV-101	Participants who previously received AV-101 35 mg in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.
Continuing AV-101 70 mg	AV-101	Participants who previously received AV-101 70 mg in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-emergent Adverse Events	From date of first dose to 30 days after date of last dose (up to approximately 21 months)	An Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious Adverse Events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Secondary Outcome Measures

Name	Time	Method

Locations (72): Arizona Pulmonary Specialist. LTD.
🇺🇸
Phoenix, Arizona, United States
University of Arizona, Department of Medicine
🇺🇸
Tucson, Arizona, United States
UCLA/David Geffen School of Medicine-Pulmonary and Criticial Care
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Los Angeles, California, United States
Kaiser Permanente - Los Angeles Medical Center
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Los Angeles, California, United States
UC Davis Medical Center
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Sacramento, California, United States
University of California
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San Francisco, California, United States
GW Medical Faculty Associates
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Washington, District of Columbia, United States
Mayo Clinic Florida
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Jacksonville, Florida, United States
Emory University
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Atlanta, Georgia, United States
Indiana University Health
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Indianapolis, Indiana, United States
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Arizona Pulmonary Specialist. LTD.
🇺🇸Phoenix, Arizona, United States