Pulmonary Arterial Hypertension: Safety and Efficacy of AV-101

Summary

This study focuses on individuals who have pulmonary arterial hypertension (PAH). PAH is caused by a narrowing of the blood vessels that connect the lungs to the heart and leads to an increase in the pressure inside these blood vessels. The purpose of the study is to evaluate the effects of an investigational drug called AV-101 for the treatment of PAH. AV-101 is a dry powder that is inhaled into the lungs via the mouth; it is involved in blocking enzymes that may activate proteins that cause the pulmonary artery to thicken. Participants will be randomly assigned to receive either AV-101 or placebo/inactive substance (1 in 4 chance of receiving placebo).


Inclusion Criteria

  • PAH belonging to one of the subgroups:
  • I/HPAH, PAH-CTD,
  • 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),
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Study Location(s)

Beverly

More about this Clinical Trial

Full Title

IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101

Details
Disease Type/Condition

Other

Principal Investigator

Matusov, Yuri

Age Group

Adult

Phase

II

IRB Number

STUDY00001948

ClinicalTrials.gov ID

NCT05036135

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Other

Principal Investigator

Matusov, Yuri

Age Group

Adult

Phase

II

IRB Number

AV-101-002

ClinicalTrials.gov ID

NCT05036135

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?