Summary

for people ages 18 years and up (full criteria)
at UC Davis
study started
estimated completion

Description

Summary

The primary objective of this study is to evaluate the long-term safety of LIQ861 in patients with pulmonary arterial hypertension (PAH).

Official Title

A Global, Open-Label Extension Study for Participants in LIQ861 Trials to Evaluate the Long-term Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Patients

Details

One of the greatest impediments to patient treatment satisfaction with current inhaled treprostinil therapy is inconvenience. Currently, PAH patients using inhaled treprostinil may require more than 36 breaths per day using a nebulizer requiring daily set up and cleaning. The use of a discrete, hand-held dry powder inhaler to deliver treprostinil to the lungs could represent a major improvement in convenience and patient satisfaction, thereby improving the quality of life for PAH patients. Liquidia is pursuing approval of LIQ861, an inhalation dry powder formulation of treprostinil that is produced using Liquidia's PRINT® Technology (Particle Replication in Nonwetting Templates), as an alternative to current inhaled treprostinil therapy for the treatment of patients with PAH (WHO Group 1).

Keywords

Primary Pulmonary Hypertension Pulmonary Arterial Hypertension Idiopathic Pulmonary Arterial Hypertension Heritable Pulmonary Arterial Hypertension Drug Induced Pulmonary Arterial Hypertension Toxin Induced Pulmonary Arterial Hypertension Connective tissue disease Hypertension, Pulmonary Familial Primary Pulmonary Hypertension Hypertension Treprostinil LIQ861 Inhaled Treprostinil

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Evidence of a personally signed and dated informed consent document exists indicating that the patient has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures.
  2. Patient is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  3. Patient has fulfilled all entry criteria at the time of enrollment in original study with LIQ861.
  4. Patient has completed the protocol defined end of study procedures or met a protocol-defined and adjudicated endpoint in the original LIQ861 study in which they were enrolled.
  5. Patient, whether male or female, agrees to use a medically acceptable method of contraception throughout the entire study period from informed consent through the termination visit, if the possibility of conception exists. Eligible male and female patients must also agree not to participate in a conception process (e.g., actively attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) during the study and for 30 days after the last dose of LIQ861.

You CAN'T join if...

  1. Patient prematurely discontinued LIQ861 due to a drug-related AE/SAE or tolerability issue in the original LIQ861 study in which they were enrolled, or patient did not complete protocol defined study procedures at an end of study visit (not Early Termination visit) in their original LIQ861 study.
  2. Patient withdrew consent during participation in another LIQ861 study.
  3. Patient is a female who wishes to become pregnant or who has a positive pregnancy test on Day 1 (LTI-302 Study Initiation Visit).
  4. Patient has undergone lung or heart/lung transplant or the initiation of parenteral (intravenous [IV] infusion or subcutaneous injection) therapy with a prostacyclin during the time since participation in their original LIQ861 study.
  5. Any reason exists that, in the opinion of the Investigator or Medical Monitor, precludes the patient from participating in the study, e.g., any previous or intercurrent medical condition that may increase the risk associated with study participation or that would confound study analysis or impair study participation or cooperation.

Locations

  • UC Davis Medical Center
    Sacramento California 95817 United States
  • Los Angeles Biomedical Research Center
    Torrance California 90502 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Liquidia Technologies, Inc.
ID
NCT03992755
Phase
Phase 3
Study Type
Interventional
Last Updated