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Tyrosine Kinase Inhibitor

Inhaled Imatinib for Pulmonary Arterial Hypertension (IMPAHCT Trial)

Phase 2 & 3
Recruiting
Research Sponsored by Aerovate Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
World Health Organization (WHO) Functional Class II, III or IV symptoms
Stable concomitant background therapy of at least two PAH approved medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

IMPAHCT Trial Summary

This trial is testing a new way to give a drug to people with PAH, and is measuring how well it works compared to a placebo.

Who is the study for?
This trial is for people with Pulmonary Arterial Hypertension (PAH) who can walk at least 100 meters but not more than 475 meters. They should be on stable PAH medication and have WHO Functional Class II, III or IV symptoms. It's not for those with left-sided heart disease, other types of pulmonary hypertension, or women who are pregnant or breastfeeding.Check my eligibility
What is being tested?
The IMPAHCT study is testing AV-101 (inhaled imatinib) to see if it helps patients with PAH. The first part will find the best dose by comparing three different amounts to a placebo. The second part measures how far patients can walk in six minutes after taking the drug for 24 weeks.See study design
What are the potential side effects?
While specific side effects of AV-101 aren't listed here, similar drugs often cause respiratory issues like coughing or wheezing, digestive problems, headaches, fatigue and sometimes dizziness or swelling.

IMPAHCT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My symptoms are moderate to very severe according to WHO standards.
Select...
I have been on two stable PAH treatments.
Select...
I can walk between 100 and 475 meters in 6 minutes.

IMPAHCT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 2b: Change from Baseline in Pulmonary Vascular Resistance (PVR)
Phase 3: Change from Baseline in Six Minute Walk Distance (6MWD)
Secondary outcome measures
Phase 2b: Change from Baseline in Health-Related Quality of Life emPHasis-10 Questionnaire Score
Phase 2b: Change from Baseline in N-terminal pro B-type natriuretic peptide (NT-proBNP)
Phase 2b: Change from Baseline in Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2.0 Risk Score
+8 more

IMPAHCT Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase 3 dose AV-101 (Optimal dose selected in Phase 2b)Experimental Treatment1 Intervention
Group II: Phase 2b medium dose AV-101Experimental Treatment1 Intervention
Group III: Phase 2b low dose AV-101Experimental Treatment1 Intervention
Group IV: Phase 2b high dose AV-101Experimental Treatment1 Intervention
Group V: Phase 2b PlaceboPlacebo Group1 Intervention
Group VI: Phase 3 PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AV-101
2018
Completed Phase 2
~230

Find a Location

Who is running the clinical trial?

Aerovate TherapeuticsLead Sponsor
1 Previous Clinical Trials
462 Total Patients Enrolled
1 Trials studying Pulmonary Arterial Hypertension
462 Patients Enrolled for Pulmonary Arterial Hypertension

Media Library

AV-101 (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05036135 — Phase 2 & 3
Pulmonary Arterial Hypertension Research Study Groups: Phase 3 dose AV-101 (Optimal dose selected in Phase 2b), Phase 2b low dose AV-101, Phase 2b medium dose AV-101, Phase 2b high dose AV-101, Phase 2b Placebo, Phase 3 Placebo
Pulmonary Arterial Hypertension Clinical Trial 2023: AV-101 Highlights & Side Effects. Trial Name: NCT05036135 — Phase 2 & 3
AV-101 (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05036135 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do the inclusion criteria for this research allow octogenarians to participate?

"This trial is only for patients aged 18-75. Out of the 653 similar clinical trials, 56 are for minors and 697 are for adults over 65 years old."

Answered by AI

Are there other facilities in this state that are also testing this treatment?

"This study is recruiting from a total of 13 locations, which are listed below. The Ohio State University Wexner Medical Center (Columbus), Kaiser Permanente Los Angeles Medical Center (Los Angeles), Washington University School of Medicine (Saint Louis)."

Answered by AI

How many people are included in this clinical trial?

"Yes, the information available on clinicaltrials.gov verifies that this research is still recruiting participants. The trial was first advertised on December 2nd, 2021 and has been updated as recently as August 12th, 2022. 462 individuals are needed for the study to take place at 13 locations."

Answered by AI

Can you give some examples of other research projects that have used AV-101?

"AV-101 was first investigated in 2021 by Mayo Clinic Florida. Out of the 18,289 completed clinical trials, 2 are still ongoing. The majority of these studies take place in Columbus, Ohio."

Answered by AI

Are there any available slots for this research project?

"The trial is still open and recruiting patients, as seen on clinicaltrials.gov. The posting dates for this trial are December 2nd, 2021 to August 12th, 2022."

Answered by AI

Am I eligible to participate in this research study?

"462 people who have pulmonary arterial hypertension and are between 18-75 years old qualify for this clinical trial."

Answered by AI

Has a trial like this been done before?

"Research for AV-101 began in 2021. The first clinical study, which was 462 patients strong and sponsored by Aerovate Therapeutics, occurred that same year. After the favorable results of the initial Phase 2 & 3 trial, there are now two active studies being conducted in 12 different cities across 4 countries."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH)
2021. "A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05036135.
All > Pulmonary Arterial Hypertension > Pulmonary Hypertension
~92 spots leftby Dec 2024
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