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
- mPAP ≥ 25 mmHg (at rest),
- 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