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

TERMINATEDPHASE3

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)

NCT05557942•Aerovate Therapeutics

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.

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.

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

Los Angeles, California, United States

Kaiser Permanente - Los Angeles Medical Center

Los Angeles, California, United States

UC Davis Medical Center

Sacramento, California, United States

University of California

San Francisco, California, United States

GW Medical Faculty Associates

Washington D.C., District of Columbia, United States

Mayo Clinic Florida

Jacksonville, Florida, United States

Emory University

Atlanta, Georgia, United States

Indiana University Health

Indianapolis, Indiana, United States

Key Dates

Start Date

November 2, 2022

Primary Completion Date

August 8, 2024

Completion Date

August 8, 2024

Last Updated

October 10, 2024

Enrollment

186

ACTUAL participants

Conditions

Pulmonary Arterial Hypertension

Interventions

AV-101

DRUG

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

NCT06649110

Healthy Volunteers, Pulmonary Arterial Hypertension

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RECRUITINGPHASE3

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

NCT07218029

Pulmonary Arterial Hypertension

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RECRUITINGPHASE1

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 10, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

COMPERA / COMPERA-KIDS

The MObile Health InterVEntion in Pulmonary Arterial Hypertension (MOVE PAH) Study

China Pulmonary Vascular Disease Intervention Diagnosis and Management Study-right Heart Catheterization