Extension Study for Participants in LIQ861 Trials to Evaluate the Long-term Safety of Dry Powder Inhalation of Treprostinil
Primary Pulmonary Hypertension
About this trial
This is an interventional treatment trial for Primary Pulmonary Hypertension focused on measuring Pulmonary Arterial Hypertension, Idiopathic Pulmonary Arterial Hypertension, Heritable Pulmonary Arterial Hypertension, Drug Induced Pulmonary Arterial Hypertension, Toxin Induced Pulmonary Arterial Hypertension, Connective tissue disease
Eligibility Criteria
Inclusion Criteria:
- 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.
- Patient is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Patient has fulfilled all entry criteria at the time of enrollment in original study with LIQ861.
- 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.
- 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.
Exclusion Criteria:
- 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.
- Patient withdrew consent during participation in another LIQ861 study.
- Patient is a female who wishes to become pregnant or who has a positive pregnancy test on Day 1 (LTI-302 Study Initiation Visit).
- 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.
- 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.
Sites / Locations
- Banner University Medical Center
- Arizona Pulmonary Specialists, Ltd.
- West Los Angeles VA Healthcare Center
- UC Davis Medical Center
- Los Angeles Biomedical Research Center
- University of Colorado Anschutz Medical Campus
- University of Florida
- Mayo Clinic-Jacksonville
- AdventHealth
- Emory University School of Medicine
- Northwestern Medicine, Feinberg School of Medicine
- University of Chicago Medicine
- University of Kansas Medical Center
- Ochsner Medical Center
- Tufts Medical Center
- Mayo Clinic-Rochester
- University of New Mexico Health Science Center
- University of Cincinnati Medical Center
- Oregon Health and Science Center
- Alleghany General Hospital
- UPMC Presbyterian Hospital
- UT Southwestern Medical Center
- Houston Methodist Lung Center
- University of Texas Health Science Center at San Antonio
- INOVA Fairfax Medical Campus
Arms of the Study
Arm 1
Experimental
LIQ861 Inhaled Treprostinil
LIQ861 inhaled treprostinil at capsule strengths of 25 μg, 50 μg, 75 μg and 100 μg. LIQ861 will be administered using the RS00 Model 8 dry powder inhalation (DPI) device (Plastiape S.p.A.; Osnago, Italy) at dose levels of 25 μg capsule strength to 200 μg capsule strength treprostinil four times a day (QID) in individual patients. Titrating to dose levels beyond 200 μg capsule strength QID, under clinical investigator supervision, requires review and approval from the Medical Monitor.