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Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial (IMPAHCT) or A Phase 2b/3, Randomized, Controlled, 24-week Dose Ranging and Confirmatory Study of AV-101 in Patients with PAH
EU CTIS ID: 2023-508734-34-00
What this study is testing
The objective of the study is to establish an optimal dose based primarily upon the change in PVR assessed by right heart catheterization (RHC) and the safety and tolerability of AV-101 as evaluated in the Phase 2b Part of the study. The optimal dose will be taken into the Phase 3 Part of the study where the placebo-corrected change in 6MWD after 24 weeks of treatment will be used as the primary endpoint.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female between 18 and 75 years of age inclusive at the Screening Visit
- A diagnosis of PAH belonging to one of the subgroups of the NICE classification of Group 1*: a. I/HPAH, PAH-CTD, b. PAH due to drugs and/or toxins/chemicals (having been in the care of the investigator for at least one year with no relapses of drug or toxin/chemical abuse), c. HIV associated or d. PAH due to repaired congenital heart disease (at least 1 year since repair). *Excluding patients with Portopulmonary Hypertension
- World Health Organization (WHO) Functional Class II, III or IV symptoms
- Must be able to walk a distance of at least 100 m but no more than 475 m during the screening 6-minute walk test.
You likely can't join if
- Pulmonary hypertension (PH) belonging to Groups 2 to 5 of the 2018 NICE classification and Group 1 diagnosed with Portopulmonary Hypertension.
- A history of left ventricular ejection fraction (LVEF) ≤ 40% on echocardiogram within 12 months of screening, or clinically significant ischemic, mitral or aortic valve disease, or constrictive heart disease, in the opinion of the Investigator
- Pregnant or breast-feeding females
The study team makes the final eligibility decision.
Where it's taking place
- Chile
- Turkey
- United Kingdom
- Colombia
- Mexico
- South Africa
- Brazil
- Israel
- Argentina
- Canada
- China
- United States
- Puerto Rico
- Australia
- Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chile; Turkey; United Kingdom; Colombia; Mexico; South Africa and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.