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Actively Recruiting
Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (IMPAHCT-FUL)
About
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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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.
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Study Stats
Protocol No.
22-001843
Category
Lung/Respiratory Disorders
Principal Investigator
Contact
Location
- UCLA Westwood