General Information
Age Group
AdultStatus
ActiveProtocol Number
LTI-301Background Information
The purpose of this study to evaluate the long-term safety and tolerability of inhaled LIQ861 (treprostinil) using a dry powder inhaler.
National Clinical Trial (NCT) identifier on clinicaltrials.gov: NCT03399604
Offered At
Inova Heart and Vascular Institute
Advanced Lung Disease and Transplant Clinic
3300 Gallows Road, Falls Church, VA 22042
Principal Investigator
Oksana Shlobin, MD
Eligibility Information
- Male or female patients =/> 18 years of age
- Diagnosed with PAH belonging to Nice Clinical Classification Grp 1
- NYHA Functional Class II-IV at Screening
- Can complete a baseline 6MWD =/> 150m
- FEV1 =/> 60% and FEV1/FVC ratio =/> 60% during the 6 month period before enrollment
Ineligibility Information
- Diagnosed with PH in the Nice Classification Groups 2-5, or PAH Group 1 subgroups 1.4.3 (associated with portal hypertension) or 1.4.5 (associated with schistosomiasis)
- Patient is currently taking oral prostacyclin analogues or agonists, including treprostinil and selexipag
- Uncontrolled systemic hypertension (=/>160/100 mmHg)
- Has had an atrial septostomy
- Has had a pulmonary infarction within 2 weeks of screening
- Pregnancy
- Has had a stroke or transient ischemic attack within 6 months of screening
- Severe hepatic or renal impairment