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A Phase 3 Open-label, Multicenter Study to Evaluate the Long-term Safety and Tolerability of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group I) Patients This study is in follow-up

General Information

Age Group

Adult

Status

Active

Protocol Number

LTI-301

Background 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