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8110 Gatehouse Road, Falls Church, VA 22042

ABI-009, an mTOR Inhibitor, for Patients With Severe Pulmonary Arterial Hypertension


General Information

Age Group




Protocol Number


Offered At

Inova Fairfax Hospital
3300 Gallows Road
Falls Church, VA 22042

Principal Investigator

Mardi Gomberg, MD

Eligibility Information

  • Male or female age >18 year old with a current diagnosis of WHO Group 1 PAH including idiopathic pulmonary arterial hypertension (IPAH), heritable pulmonary arterial hypertension (HPAH), drug and toxin induced PAH, or PAH associated with connective tissue disease, or congenital heart defects (repaired greater than 1 year prior to Screening)
  • Must meet following hemodynamic definition prior to initiation of study drug
  • Mean PAP of ≥ 25 mm Hg
  • PCWP or left ventricular end diastolic pressure (LVEDP) of ≤ 12 mm
  • PVR >5 mmHg/L/min (Woods unit)
  • Functional class III or IV according to the WHO set forth at the Dana Point Classification 2008 Meeting
  • On 2 or more specific standard PAH therapies (for ≥ 12 consecutive weeks and at stable dose for ≥ 8 consecutive weeks) unless documented inability to tolerate 2 standard therapies
  • Meet the following criteria determined by pulmonary function tests completed no more than 24 weeks prior to screening, performed with or without bronchodilation:
    • Forced expiratory volume in one second (FEV1) ≥ 55% of predicted normal
    • FEV1:forced vital capacity (FVC) ratio ≥ 0.60
    • 6MWD ≥150 meters and ≤450 meters
    • Negative serum pregnancy test
    • Female of childbearing age either surgically sterilized or using acceptable method of contraception
    • Ability to provide written informed consent by the patient or legal guardian

Ineligibility Information

  • History of heart disease including left ventricular ejection fraction (LVEF) ≤ 40% or clinically significant valvular constrictive or atherosclerotic heart disease (myocardial infarction, angina, cerebrovascular accident)
  • History of malignancy in 2 years prior to enrollment
  • Pulmonary hypertension (PH) belonging to groups 2 to 5 of the 2013 Nice classification
  • Current or recent (< 3 months) use of inotropic or vasopressor agents for the treatment of PAH
  • Recent (< 3 months) PAH related hospital admission
  • Naïve to available standard PAH therapy
  • Concomitant genetic or acquired immunosuppressive diseases (such as HIV, AIDS)
  • Other exclusion criteria may apply