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Study Status: 
Open
Study Description: 

Study Name: ALIVE

Study Objective: Determine the effect of GB002 on improving   pulmonary hemodynamics in subjects with World Health Organization (WHO) Group   1 PAH who are WHO Functional Class (FC) II or III

 Key Inclusion Criteria:

  • current diagnosis of symptomatic PAH classified by one of the following:
  • a. Idiopathic PAH (IPAH) or heritable pulmonary arterial hypertension (HPAH).

b. PAH associated with one of the following connective tissue diseases (CTDs):

− Systemic sclerosis,

− Mixed CTD or overlap syndrome,

− Systemic lupus erythematosus.

c. PAH associated with anorexigen or methamphetamine use.

d. Congenital heart disease with simple systemic to pulmonary shunt at least 1 year

     after surgical repair.

  • 6MWD ≥ 150 meters and ≤ 550 meters at screening.
  • WHO FC II or III symptomatology.
  • RHC confirming PAH
  1. mPAP ≥ 25 mmHg (at rest),
  2. Pulmonary capillary wedge pressure ≤ 15 mmHg, or mean left atrial pressure (mLAP) or left ventricular-end diastolic pressure (LVEDP) ≤ 15 mmHg in the absence of left atrial obstruction,

c. PVR ≥ 400 dyne•s/cm5.

Key Exclusion Criteria:

  • Evidence of chronic thromboembolic disease or acute pulmonary embolism as assessed by ventilation-perfusion (V/Q) scan, computed tomography (CT)-angiogram, or pulmonary angiogram
  • SBP > 160 or SBP < 90
  • WHO Pulmonary Hypertension Group 2–5.
  • Untreated obstructive sleep apnea
Principal Investigator: 
Irina Sobol, MD
Contact: 

PI: Irina Sobol, MD (646) 962 5555

RC:  Katelyn Bastert, (212) 746 2698

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