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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
Treatment
Study Type
Interventional
Phase
Phase II/III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
75 Years

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
Contact
Lynne Yoder
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05557942
For detailed technical eligibility, visit ClinicalTrials.gov.